Drugs / Sunitinib
Sunitinib
also known as
Sunitinib malate · SU011248 · SUTENT · SU 11248 · NSC 736511 · SUN · SUO11248 · Sutent, sunitinib · +14 more
Small molecule targets CSF1R, FLT1, FLT3, FLT4, KDR, KIT, MET, PDGFRA, PDGFRB, RET via inhibition
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed renal cell adenocarcinoma 2 milestones | |||||
| Filed | EU (EMA) | SUTENT | renal cell adenocarcinoma | 2017-05-31 | “the European Medicines Agency (EMA) has validated for review a Type II Variation application for SUTENT in the same patient population.” pfizer.com ↗ |
| Filed | US (FDA) | SUTENT | renal cell adenocarcinoma | 2017-05-31 | “a supplemental New Drug Application (sNDA) for SUTENT® (sunitinib) has been accepted for filing by the U.S. Food and Drug Administration (FDA).” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | SUTENT | — | 2007-02-02 – 2021-08-30 | fda.gov ↗ |
| Approved | EU (EMA) | Sutent | — | 2006-07-19 | europa.eu ↗ |
| Approved | US (FDA) | SUTENT | — | 2006-01-26 | fda.gov ↗ |
Trials 362 · started per year
today
US approved 2006
EU approved 2006
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT00583063 | Oct 2007 → Apr 2008 | cancer | University of Chicago | Completed | No outcome recorded |
| Phase 0 | NCT00864864 | May 2007 → May 2011 | brain neoplasm, glioblastoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 166 trials | ||||||
| Phase 1 | NCT05687123 | Aug 2024 → Dec 2026 expected | pancreatic neuroendocrine tumor | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05245968 | Dec 2021 → Dec 2026 expected | gastrointestinal stromal tumor | Taiho Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03900793 | Aug 2019 → Aug 2027 expected | osteosarcoma | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 1 | NCT03905889 | Jun 2019 → Mar 2022 | renal cell carcinoma | Brown University | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02779283 | Jan 2016 → Apr 2018 | acute lymphoblastic leukemia, acute myeloid leukemia | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02483247 | Sep 2015 → May 2019 | cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02386111 | May 2015 → Aug 2017 | clear cell renal carcinoma | Celldex Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02164240 | Jul 2014 → Dec 2016 | gastrointestinal stromal tumor | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02074878 | Jun 2014 → May 2017 | breast cancer | Mothaffar Rimawi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02058901 | Jul 2013 → Jun 2019 | cancer | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 1 | NCT01472081 | Feb 2012 → Feb 2016 | clear cell renal carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01498835 | Feb 2012 → Nov 2014 | soft tissue sarcoma | Heidelberg University | Completed | No outcome recorded |
| Phase 1 | NCT01441388 | Dec 2011 → Nov 2013 | glioblastoma, hepatocellular carcinoma, renal cell carcinoma | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT01286896 | Apr → Dec 2011 | cancer | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01308034 | Mar 2011 → May 2016 | sarcoma | Centre Leon Berard | Completed | No outcome recorded |
| Phase 1 | NCT01243359 | Oct 2010 → Feb 2014 | cancer of unknown primary site, clear cell renal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01122615 | May 2010 → Jul 2014 | renal cell carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00813423 | Feb 2010 → Jul 2023 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01061411 | Feb 2010 → Oct 2015 | clear cell sarcoma of kidney, renal cell carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT00890747 | Aug 2009 → May 2011 | Burkitt lymphoma, HIV infectious disease, HIV-associated cancer, Hodgkins lymphoma +47 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00981890 | Jul 2009 → May 2014 | metastatic malignant neoplasm in the brain | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT01005472 | Dec 2008 → Jan 2018 | metastatic melanoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00777478 | Dec 2008 → May 2012 | colorectal cancer | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT00747305 | Oct 2008 → Jul 2014 | kidney cancer | Harry Drabkin | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00904657 | Oct 2008 → Apr 2009 | hypertensive disorder | University of Cologne | Completed | No outcome recorded |
| Phase 1 | NCT00788060 | Oct 2008 → Dec 2012 | renal cell carcinoma | Daniel George, MD | Completed | No outcome recorded |
| Phase 1 | NCT00729833 | Sep 2008 → Aug 2011 | cancer of unknown primary site | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT00732992 | Aug 2008 → Nov 2009 | cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00555672 | Aug 2008 → Dec 2009 | gastric cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00906360 | Jul 2008 → Sep 2012 | hypopharynx squamous cell carcinoma, larynx verrucous carcinoma, metastatic squamous cell carcinoma, nasal cavity and paranasal sinus squamous cell carcinoma +5 | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT00555620 | May 2008 → Aug 2010 | gastric cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00611728 | Mar 2008 → Jun 2010 | glioblastoma | Duke University | Completed | No outcome recorded |
| Phase 1 | NCT00520533 | Feb 2008 → Jul 2011 | renal cell carcinoma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded |
| Phase 1 | NCT00631527 | Feb 2008 → Jan 2015 | prostate cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00720148 | Feb 2008 → Jul 2010 | cancer | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT00631410 | Jan 2008 → Jul 2009 | colorectal neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00555256 | Nov 2007 → Feb 2010 | non-small cell lung carcinoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT00553696 | Nov 2007 → Jul 2009 | gastric neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00543504 | Oct 2007 → Apr 2020 | cancer of unknown primary site | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00694096 | Sep 2007 → Sep 2014 | renal cell carcinoma | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT00581789 | Aug 2007 → Feb 2010 | non-small cell lung carcinoma | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT00573404 | Jul 2007 → Sep 2009 | gastrointestinal stromal tumor | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00495872 | Jun 2007 → Oct 2012 | cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00499135 | May 2007 → May 2014 | clear cell renal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00524186 | May 2007 → Aug 2013 | esophageal cancer, gastric cancer | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT00462553 | Mar 2007 → Jun 2010 | cancer of unknown primary site, pancreatic adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00437372 | Mar 2007 → Dec 2010 | head and neck cancer, nervous system neoplasm, thoracic cancer | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT00372424 | Dec 2006 → Sep 2011 | breast cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00528619 | Nov 2006 → Apr 2010 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00372853 | Nov 2006 → May 2010 | renal cell carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00387920 | Oct 2006 → Sep 2012 | central nervous system teratoma, childhood central nervous system germinoma, childhood central nervous system mixed germ cell tumor, pediatric CNS choriocarcinoma +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00422344 | Oct 2006 → Feb 2010 | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00399152 | Oct 2006 → Dec 2008 | gastrointestinal stromal tumor, kidney cancer | AEterna Zentaris | Completed | No outcome recorded |
| Phase 1 | NCT00291577 | Jul 2006 → Oct 2008 | breast neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00357318 | Jun 2006 → Jul 2012 | cancer of unknown primary site | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00790595 | Jun 2006 → Jul 2009 | prostate cancer | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00421512 | Mar 2006 → May 2008 | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00402415 | Feb 2006 → Jul 2008 | neoplasm | Yale University | Terminated | No outcome recorded |
| Phase 1 | NCT00861419 | Dec 2005 → ? | cancer | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT00511849 | Nov 2005 → Feb 2009 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00599924 | Sep 2005 → Nov 2008 | colorectal neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00174434 | Sep 2005 → Aug 2007 | breast neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00618124 | May 2005 → Jul 2008 | breast cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00615446 | Mar 2005 → May 2009 | cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00712504 | Jul 2004 → Nov 2007 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1/230 trials · 1 met primary | ||||||
| Phase 1/2 | NCT06222593 | Oct 2024 → Jul 2026 overdue | renal cell carcinoma | State University of New York at Buffalo | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05024214 | Nov 2021 → Dec 2026 expected | hepatocellular carcinoma, non-small cell lung carcinoma, renal cell carcinoma | 3D Medicines (Sichuan) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06940349 | Oct 2021 → Jan 2026 overdue | refractory malignant neoplasm | Rabin Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03277924 | May 2017 → Jun 2024 | bone sarcoma, soft tissue sarcoma | Spanish Group for Research in Sarcomas | Completed | No outcome recorded |
| Phase 1/2 | NCT02380625 | Apr 2015 → Jan 2016 | Ebola hemorrhagic fever | Clinical Research Management, Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT02401815 | Mar 2015 → May 2020 | gastrointestinal stromal tumor | Cogent Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02919371 | Dec 2014 → Dec 2020 | renal cell carcinoma | King Faisal Specialist Hospital & Research Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT00905021 | Mar 2010 → Jan 2011 | breast cancer | Baylor Breast Care Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT00975806 | Sep 2009 → Oct 2011 | renal cell carcinoma | Celgene Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT00879619 | Jul 2009 → Oct 2011 | prostate adenocarcinoma | John P. Fruehauf | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00887575 | Jun 2009 → Jul 2013 | breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT01070706 | Mar → Dec 2009 | breast cancer | Jungsil Ro | Completed | No outcome recorded |
| Phase 1/2 | NCT00931450 | Mar 2009 → Oct 2011 | breast cancer | Catalan Institute of Oncology | Unknown | No outcome recorded |
| Phase 1/2 | NCT00818350 | Jan → Aug 2009 | urinary bladder neoplasm | Campania Younger Oncologists Association | Unknown | No outcome recorded |
| Phase 1/2 | NCT00753727 | Sep 2008 → Mar 2012 | soft tissue sarcoma | Australasian Sarcoma Study Group | Unknown | No outcome recorded |
| Phase 1/2 | NCT00783653 | Aug 2008 → Jul 2013 | acute myeloid leukemia | University Medical Center Hamburg-Eppendorf | Completed | No outcome recorded |
| Phase 1/2 | NCT00673816 | May 2008 → Feb 2011 | von Hippel-Lindau disease | National Eye Institute (NEI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00891475 | May 2008 → Jan 2010 | renal cell carcinoma | Kidney Cancer Research Bureau | Completed | No outcome recorded |
| Phase 1/2 | NCT00417885 | Jun 2007 → Jul 2009 | breast cancer | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT00522249 | May 2007 → May 2008 | renal cell carcinoma | The Methodist Hospital Research Institute | Terminated | No outcome recorded |
| Phase 1/2 | NCT00453154 | Mar 2007 → Jun 2013 | small cell lung carcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 1/2 | NCT00417677 | Mar → May 2007 | renal cell carcinoma | Wyeth is now a wholly owned subsidiary of Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT00463060 | Jan 2007 → Jul 2014 | cancer | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 1/2 | NCT00496223 | Sep 2006 → Jun 2007 | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 1/2 | NCT00361244 | Jul 2006 → Oct 2007 | colorectal carcinoma | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00616122 | Mar 2006 → Mar 2011 | breast cancer | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 1/2 | NCT00304200 | Mar 2006 → Oct 2007 | metastatic melanoma | Northern California Melanoma Center | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00137436 | Oct 2005 → May 2008 | prostate neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT00457743 | Jan 2005 → Aug 2008 | gastrointestinal stromal tumor | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT00113529 | Oct 2004 → Sep 2007 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2216 trials · 9 met primary · 22 missed | ||||||
| Phase 2 | NCT07667751 | Jun 2026 → Dec 2027 expected | ovarian cancer | Bai-Rong Xia | Recruiting | No outcome recorded |
| Phase 2 | NCT07477457 | Mar 2026 → Mar 2028 expected | metastatic neoplasm, osteosarcoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06208748 | Aug 2024 → Jun 2026 overdue | gastrointestinal stromal tumor | Sarcoma Alliance for Research through Collaboration | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05366816 | Oct 2023 → Dec 2026 expected | gastrointestinal stromal tumor | University of Miami | Recruiting | No outcome recorded |
| Phase 2 | NCT04644432 | Mar 2020 → Sep 2022 | renal cell carcinoma | Herlev and Gentofte Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03899155 | Aug 2019 → Aug 2029 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2 | NCT03641326 | Feb 2019 → Apr 2021 | central nervous system sarcoma, gliosarcoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03323710 | Sep 2018 → Dec 2019 | renal cell carcinoma | Military Institute od Medicine National Research Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03463460 | Jun 2018 → Apr 2027 expected | thymic carcinoma | Dwight Owen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03541902 | May 2018 → Jul 2027 expected | chromophobe renal cell carcinoma, papillary renal cell carcinoma, renal cell carcinoma associated with Xp11.2 translocations/TFE3 gene fusions, sarcomatoid renal cell carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Show all 216 trials opens the full record — a long page | ||||||
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT03909724 | Oct 2019 → Jul 2021 | colorectal cancer, metastatic neoplasm | Amsterdam UMC, location VUmc | Unknown | Missed primary |
| Phase 2/3 | NCT03025893 | Aug 2018 → Jan 2022 | adult glioblastoma, brain glioma | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Phase 2/3 | NCT01164202 | Jul 2010 → Jul 2017 | liver cancer | Federation Francophone de Cancerologie Digestive | Completed | No outcome recorded |
| Phase 318 trials · 4 met primary · 10 missed | ||||||
| Phase 3 | NCT05208047 | Apr 2022 → Sep 2025 overdue | gastrointestinal stromal tumor, metastatic malignant neoplasm | Cogent Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT02535351 | Nov 2015 → Sep 2018 | clear cell renal carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Terminated | No outcome recorded |
| Phase 3 | NCT01064310 | May 2010 → Oct 2011 | renal cell carcinoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01099423 | Apr 2010 → Apr 2016 | kidney cancer | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | Missed primary |
| Phase 3 | NCT00699374 | Jul 2008 → Dec 2011 | hepatocellular carcinoma | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT00676650 | Jul 2008 → Dec 2011 | prostate cancer | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT00693992 | Jun 2008 → Nov 2013 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 3 | NCT00375674 | Aug 2007 → Apr 2016 | kidney neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00457392 | Jul 2007 → Jul 2010 | non-small cell lung carcinoma | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00372567 | Jun 2007 → Nov 2009 | gastrointestinal stromal tumor | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00457691 | Jun 2007 → Mar 2010 | colorectal cancer | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00428597 | Jun 2007 → Apr 2009 | pancreatic endocrine carcinoma | Pfizer | Terminated | Met primary |
| Phase 3 | NCT00435409 | Feb 2007 → Dec 2009 | breast cancer | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00393939 | Feb 2007 → Feb 2010 | breast neoplasm | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00373256 | Nov 2006 → Jun 2009 | breast neoplasm | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00373113 | Nov 2006 → Oct 2009 | breast cancer | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT00326898 | Apr 2006 → Aug 2015 | clear cell renal carcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 3 | NCT00083889 | Aug 2004 → Sep 2008 | renal cell carcinoma | Pfizer | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT02691793 | Nov 2017 → Aug 2019 | refractory malignant neoplasm | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02570789 | Dec 2012 → Dec 2018 | clear cell renal carcinoma | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01525550 | Jun 2012 → Mar 2016 | pancreatic neuroendocrine tumor | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT01402089 | Jan 2012 → Jul 2015 | gastrointestinal stromal tumor, non-small cell lung carcinoma, renal cell carcinoma | Markus Joerger | Completed | No outcome recorded |
| Phase 4 | NCT00930345 | Dec 2008 → Oct 2013 | renal cell carcinoma | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 4 | NCT00793871 | Nov 2008 → Apr 2014 | gastrointestinal stromal tumor | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00706706 | Jul 2008 → Aug 2011 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase not applicable17 trials | ||||||
| — | NCT06032728 | Oct 2023 → Oct 2033 expected | clear cell renal carcinoma | First Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| — | NCT02688491 | Jul 2016 → Jul 2026 overdue | kidney cancer | First Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| — | NCT02450123 | Mar 2016 → Aug 2019 | refractory malignant neoplasm | Samsung Medical Center | Completed | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT02239952 | Nov 2014 → Nov 2021 | malignant glioma | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| — | NCT02013089 | Dec 2013 → May 2017 | digestive system cancer | Sun Yat-sen University | Unknown | No outcome recorded |
| — | NCT01740154 | Sep 2012 → Mar 2014 | renal cell carcinoma | Case Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01636908 | Aug 2011 → Jan 2018 | cancer | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| — | NCT01190241 | Aug 2010 → Dec 2017 | cancer, metastatic neoplasm | Amsterdam UMC, location VUmc | Terminated | No outcome recorded |
| — | NCT01054911 | Oct 2009 → Sep 2014 | neoplasm | University of Alabama at Birmingham | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00943839 | Feb 2009 → Nov 2014 | kidney cancer | Centre Antoine Lacassagne | Completed | No outcome recorded |
| — | NCT00656669 | Apr 2008 → Sep 2010 | breast cancer | Indiana University | Completed | No outcome recorded |
| — | NCT00849186 | Aug 2007 → Jul 2009 | kidney cancer | Roswell Park Cancer Institute | Completed | No outcome recorded |
| — | NCT00428220 | Jul 2007 → Aug 2014 | breast cancer, gastric cancer, gastrointestinal stromal tumor, hepatocellular carcinoma +6 | Pfizer | Completed | No outcome recorded |
| — | NCT00531544 | Feb 2007 → Jun 2012 | renal cell carcinoma | King Faisal Specialist Hospital & Research Center | Completed | No outcome recorded |
| — | NCT00443534 | May 2006 → Dec 2011 | neoplasm | Pfizer | Completed | No outcome recorded |
| — | NCT00798889 | Mar 2004 → Dec 2011 | cancer | Pfizer | Completed | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT00130897 | Jul 2005 → Nov 2011 | renal cell carcinoma | Pfizer | Approved for marketing | No outcome recorded |
| — | NCT00094029 | Sep 2004 → Oct 2011 | digestive system neoplasm | Pfizer | Approved for marketing | No outcome recorded |
| — | NCT06948955 | — | gastrointestinal stromal tumor | Cogent Biosciences, Inc. | Available | No outcome recorded |
| Comparator or background therapy78 trials | ||||||
| Phase 1 | NCT03275558 Comparator | Jul 2018 | gliosarcoma | Center Trials & Treatment | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01548170 Comparator | Apr → Jul 2011 | cancer | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Completed | No outcome recorded |
| Phase 1 | NCT00884676 Background | Nov 2008 → Nov 2013 | cancer of unknown primary site | Jaime Merchan | Completed | No outcome recorded |
| Phase 1 | NCT01258348 Background | Jul 2008 → Feb 2012 | renal cell carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01743300 Comparator | Jul 2007 → Dec 2010 | — | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00705874 Background | May 2006 → Aug 2011 | cancer | Progen Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02446795 Background | Nov 2016 → Dec 2017 | renal cell carcinoma | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 2 | NCT06326190 Comparator | Mar 2025 → Apr 2027 expected | meningioma | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 2 | NCT06427057 Background | Jul 2024 → Dec 2025 overdue | urinary system neoplasm | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05773274 Comparator | Jan 2024 → Apr 2029 expected | digestive system neuroendocrine tumor, grade 1/2 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT04633122 Comparator | Nov 2020 → Jul 2022 | gastrointestinal stromal tumor | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02959554 Comparator | Dec 2016 → Aug 2020 | renal cell carcinoma | AIO-Studien-gGmbH | Terminated | No outcome recorded |
| Phase 2 | NCT03379012 Background | Feb 2016 → Jan 2018 | renal cell carcinoma | Kidney Cancer Research Bureau | Completed | No outcome recorded |
| Phase 2 | NCT02230176 Comparator | Feb 2015 → Apr 2024 | pancreatic endocrine carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 2 | NCT02187302 Comparator | Jul 2014 → Jul 2016 | renal cell carcinoma | NewLink Genetics Corporation | Completed | Missed primary |
| Phase 2 | NCT01984242 Comparator | Jan 2014 → Oct 2016 | renal cell carcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT02072031 Comparator | Dec 2013 → Dec 2016 | renal cell carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT01835158 Comparator | Jul 2013 → Apr 2016 | clear cell renal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01616186 Comparator | Jul 2012 → Dec 2015 | metastatic malignant neoplasm | Andrea Harzstark | Withdrawn | No outcome recorded |
| Phase 2 | NCT01673386 Comparator | Jul 2012 → Jan 2014 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01396408 Comparator | Feb 2012 → Jul 2015 overdue | — | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01829841 Comparator | May 2011 → Apr 2013 | renal cell carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01306045 Comparator | Feb 2011 → Feb 2014 | non-small cell lung carcinoma, small cell lung carcinoma, thymic carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01216371 Comparator | Oct 2010 → Oct 2015 | renal cell carcinoma | Association of Urologic Oncology (AUO) | Unknown | No outcome recorded |
| Phase 2 | NCT01108445 Comparator | Sep 2010 → Feb 2015 | renal cell carcinoma | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT01185366 Comparator | Aug 2010 → Sep 2019 | kidney cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT01147822 Comparator | May 2010 → May 2012 | renal cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01024920 Comparator | Dec 2009 → Nov 2011 | renal cell carcinoma | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00982657 Comparator | Sep 2009 → Mar 2014 | cancer | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00556205 Comparator | Sep 2009 | renal cell carcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT01082809 Comparator | Mar 2009 → Jan 2012 | adenocarcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01506336 Comparator | Oct 2008 → Sep 2011 | gastrointestinal stromal tumor | AB Science | Completed | No outcome recorded |
| Phase 2 | NCT00709995 Background | Jun 2008 → Feb 2010 | renal cell carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00578526 Comparator | Apr 2008 → Jul 2014 | urinary bladder cancer, urothelial carcinoma | AHS Cancer Control Alberta | Completed | No outcome recorded |
| Phase 2 | NCT00619268 Comparator | Feb 2008 → Feb 2012 | renal cell carcinoma | Centre Leon Berard | Completed | Missed primary |
| Phase 2 | NCT00678119 Background | Jan 2008 → May 2012 | renal cell carcinoma | Argos Therapeutics | Completed | Missed primary |
| Phase 2 | NCT00491738 Background | Aug 2007 → Jan 2008 | renal cell carcinoma | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00393796 Comparator | May 2006 → Dec 2011 | urinary bladder cancer | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT07218926 Comparator | Dec 2025 → May 2028 expected | gastrointestinal stromal tumor | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT07165418 Comparator | Sep 2025 → Dec 2028 expected | renal cell carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06726421 Background | Sep 2024 → Sep 2030 expected | renal cell carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT05734105 Comparator | Dec 2023 → Dec 2027 expected | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05678673 Comparator | Jan 2023 → Jul 2025 overdue | renal cell adenocarcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05477576 Comparator | Mar 2022 → Dec 2026 expected | carcinoid tumor, pancreatic neuroendocrine tumor | RayzeBio, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05043090 Comparator | Oct 2021 → Dec 2025 overdue | papillary renal cell carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04409223 Comparator | Sep 2020 → Mar 2022 | gastrointestinal stromal tumor | Jiangsu HengRui Medicine Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04523272 Comparator | Aug 2020 → Jun 2025 overdue | kidney cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT04394975 Comparator | Aug 2020 → Apr 2024 | renal cell adenocarcinoma | Shanghai Junshi Bioscience Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03768063 Comparator | Feb 2019 → Jul 2028 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03673501 Comparator | Feb 2019 → Sep 2021 overdue | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Active not recruiting | Missed primary |
| Phase 3 | NCT03729245 Comparator | Dec 2018 → Jan 2022 | renal cell carcinoma | Nektar Therapeutics | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT03260894 Comparator | Dec 2017 → Aug 2018 | renal cell carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03091192 Comparator | Jul 2017 → Aug 2019 overdue | renal cell carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 3 | NCT03141177 Comparator | Jul 2017 → Feb 2020 overdue | renal cell carcinoma | Bristol-Myers Squibb | Active not recruiting | Met primary |
| Phase 3 | NCT02811861 Comparator | Oct 2016 → Aug 2020 overdue | renal cell carcinoma | Eisai Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT02853331 Comparator | Sep 2016 → Oct 2018 | renal cell carcinoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02684006 Comparator | Mar 2016 → Aug 2023 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02420821 Comparator | May 2015 → Feb 2020 | renal cell carcinoma | Hoffmann-La Roche | Completed | Mixed |
| Phase 3 | NCT02231749 Comparator | Oct 2014 → Jun 2017 | renal cell carcinoma | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT01582672 Comparator | Nov 2012 → Apr 2018 | renal cell carcinoma | Argos Therapeutics | Terminated | Missed primary |
| Phase 3 | NCT01694277 Comparator | Apr 2012 → Dec 2020 | gastrointestinal stromal tumor | AB Science | Completed | No outcome recorded |
| Phase 3 | NCT01265901 Background | Dec 2010 → Jul 2015 | renal cell carcinoma | Immatics Biotechnologies GmbH | Completed | Missed primary |
| Phase 3 | NCT01481870 Comparator | Jan 2010 → Jul 2013 | renal cell carcinoma | Yamagata University | Unknown | No outcome recorded |
| Phase 3 | NCT00732914 Comparator | Jan 2009 → Oct 2013 | renal cell carcinoma | Sponsor GmbH | Completed | Missed primary |
| Phase 3 | NCT00720941 Comparator | Aug 2008 → May 2012 | renal cell carcinoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00471328 Background | Mar 2007 → Aug 2008 | gastrointestinal stromal tumor | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00397345 Background | Sep 2006 → Dec 2009 | clear cell renal carcinoma | Oxford BioMedica | Completed | Missed primary |
| Phase 3 | NCT00075218 Comparator | Dec 2003 → May 2008 | gastrointestinal stromal tumor | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT05949424 Comparator | May 2024 → Mar 2025 | breast carcinoma, endometrial carcinoma, ovarian carcinoma, renal cell carcinoma +1 | University Medical Center Groningen | Unknown | No outcome recorded |
| Phase 4 | NCT02555748 Comparator | Nov 2015 → Jan 2020 | renal cell carcinoma | Institut Claudius Regaud | Completed | No outcome recorded |
| — | NCT05751733 Comparator | Feb 2023 → Jan 2026 overdue | gastrointestinal stromal tumor | Xiangya Hospital of Central South University | Recruiting | No outcome recorded |
| — | NCT05816642 Comparator | Aug 2022 → Dec 2023 | renal cell carcinoma | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT03862768 Comparator | Jul 2019 → Jun 2021 | gastrointestinal stromal tumor | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| — | NCT03571438 Comparator | Oct 2017 → Sep 2022 | kidney cancer | University Hospital, Grenoble | Unknown | No outcome recorded |
| — | NCT02208583 Comparator | Jun 2014 → Dec 2016 | hormone-resistant prostate carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| — | NCT02208128 Comparator | May 2014 → Feb 2018 | renal cell carcinoma | Heidelberg University | Unknown | No outcome recorded |
| — | NCT01502228 Background | Oct 2011 → Feb 2014 | renal cell carcinoma | Indiana University | Terminated | No outcome recorded Stop: Business |
| — | NCT00537056 Background | Oct 2007 → Oct 2011 | renal cell carcinoma | Stanford University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 73
| Date | Issuer | Release |
|---|---|---|
| 2025-02-15 | Exelixis | Results Exelixis Announces Final Five-Year Follow-up Results from CheckMate -9ER Trial Evaluating CABOMETYX® (cabozantinib) in Combination with Opdivo® (nivolumab) in Patients with Advanced Kidney Cancer at ASCO GU 2025 exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). |
| 2024-01-22 | Ipsen | Results Latest Phase III trial data investigating Cabometyx® in combination with immunotherapy to be presented at ASCO GU 2024 ipsen.com ↗
Four-year extended follow-up data from landmark Phase III CheckMate -9ER trial reinforce sustained long-term efficacy benefits for the combination of Cabometyx® and nivolumab versus sunitinib in advanced renal cell carcinoma |
| 2024-01-22 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma bms.com ↗
Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) today announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo ® (nivolumab) in combination with CABOMETYX ® (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). |
| 2024-01-22 | Bristol-Myers Squibb | Results Eight-Year Data for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Continue to Demonstrate Longest Survival Benefit vs. Sunitinib Reported in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
Patients with previously untreated advanced or metastatic renal cell carcinoma treated with Opdivo plus Yervoy experienced a 28% reduction in the risk of death vs. sunitinib at eight years from the start of treatment, regardless of risk group |
| 2024-01-22 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma exelixis.com ↗
Results continued to show superior progression-free survival (PFS) and objective response rates (ORR) in patients treated with Opdivo plus CABOMETYX over sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) scores. |
| 2023-05-26 | Eisai Inc. | Results LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma After four years of follow-up, LENVIMA plus KEYTRUDA reduced the risk of death by 21% versus sunitinib in the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial Final results will be presented at ASCO 2023 in an oral abstract session eisai.com ↗
After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). |
| 2023-05-25 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma merck.com ↗
After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). |
| 2023-02-13 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Durable Survival with Over Three Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma bms.com ↗
Data to be featured at ASCO GU 2023 demonstrate continued overall survival, progression-free survival and objective response rate benefits with Opdivo in combination with CABOMETYX compared to sunitinib, regardless of IMDC risk score |
| 2023-02-13 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Durable Survival with Over Three Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma exelixis.com ↗
Data to be featured at ASCO GU 2023 demonstrate continued overall survival, progression-free survival and objective response rate benefits with Opdivo in combination with CABOMETYX compared to sunitinib, regardless of IMDC risk score |
| 2022-05-27 | Ipsen | Results ASCO 2022: New Cabometyx® data show encouraging results in monotherapy and in combination across different tumor types including metastatic non-small cell lung cancer ipsen.com ↗
New analyses from pivotal Phase III Checkmate -9ER trial further support the superior efficacy of Cabometyx and nivolumab over sunitinib in advanced renal cell carcinoma |
| 2022-04-28 | Mendus | Results Immunicum AB: Immunicum Publishes Phase II MERECA Trial Results of Ilixadencel in Kidney Cancer in European Urology Open Sciences mendus.com ↗
The MERECA study showed that the combination of ilixadencel with the tyrosine kinase inhibitor sunitinib was safe and associated with a positive trend for improved tumor response rate and overall survival, compared with sunitinib monotherapy (control group). |
| 2022-02-15 | Ipsen | Results Cabometyx® in combination with Opdivo® demonstrated continued survival and quality of life benefits with over two years of follow-up in the Phase III CheckMate -9ER trial ipsen.com ↗
Updated results to be presented at ASCO GU 2022 showed sustained efficacy and tumor shrinkage benefits with Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) compared to sunitinib1 |
| 2022-02-14 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Continued Survival Benefits with Over Two Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma bms.com ↗
Updated results to be presented at ASCO GU 2022 show sustained efficacy benefits with Opdivo in combination with CABOMETYX compared to sunitinib |
| 2022-02-14 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Continued Survival Benefits with Over Two Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma exelixis.com ↗
Updated results to be presented at ASCO GU 2022 show sustained efficacy benefits with Opdivo in combination with CABOMETYX compared to sunitinib |
| 2021-09-18 | Ipsen | Results ESMO 2021: Cabometyx® demonstrates sustained 78% reduction in risk of disease progression or death in people living with uncommon form of thyroid cancer ipsen.com ↗
New data demonstrated improved efficacy for Cabometyx and nivolumab regardless of prior nephrectomy status, when measured by PFS, ORR, CR and response durability outcomes, versus sunitinib (Abstract 663P). |
| 2021-09-16 | Bristol-Myers Squibb | Results Five-Year Data from CheckMate -214 Show Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Longest Median Overall Survival Currently Reported in Phase 3 Trial of Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
After a median follow-up of 67.7 months, Opdivo plus Yervoy maintained superior overall survival (OS) and response benefits versus sunitinib in both patients with intermediate- and poor-risk prognostic factors, the primary endpoint population, and across all randomized patients. |
| 2021-09-16 | Exelixis | Results Exelixis Announces CABOMETYX® in Combination with OPDIVO® Provides Efficacy Benefits Regardless of Prior Nephrectomy in Patients with Previously Untreated Advanced Renal Cell Carcinoma Based on CheckMate -9ER Analysis Presented at ESMO 2021 exelixis.com ↗
Progression-free survival and objective response rate benefits were observed with combination regimen versus sunitinib regardless of prior nephrectomy status |
| 2021-06-07 | Merck Sharp & Dohme LLC | Results New Data on KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Versus Sunitinib in First-Line Treatment for Patients With Advanced Renal Cell Carcinoma From Pivotal Phase 3 CLEAR/KEYNOTE-581 Trial Presented at 2021 ASCO Annual Meeting merck.com ↗
Results from a new analysis evaluating health-related quality of life (HRQoL) based on patient-reported outcomes are being presented during an oral abstract session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502). |
| 2021-06-07 | Eisai Inc. | Results New Data on LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) Versus Sunitinib in First-Line Treatment for Patients With Advanced Renal Cell Carcinoma From Pivotal Phase 3 CLEAR/KEYNOTE-581 Trial Presented at 2021 ASCO Annual Meeting Results From New Analysis Evaluating Health-Related Quality of Life (HRQoL) Based on Patient-Reported Outcomes Using Three HRQoL Scales eisai.com ↗
The additional data showed an improvement of specific health-related quality of life measures for patients who received LENVIMA plus KEYTRUDA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients. |
| 2021-02-15 | Eisai Inc. | Results LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma LENVIMA Plus KEYTRUDA Significantly Reduced Risk of Disease Progression or Death by 61% Versus Sunitinib, With a Median PFS of Nearly Two Years Versus Nine Months for Sunitinib LENVIMA Plus Everolimus Significantly Improved PFS and Objective Response Rate Versus Sunitinib First Results From Pivotal CLEAR Study (Study 307/KEYNOTE-581) Presented at 2021 Genitourinary Cancers Symposium (ASCO GU) and Published in the New England Journal of Medicine eisai.com ↗
LENVIMA plus everolimus also showed statistically significant improvements in PFS (HR=0.65 [95% CI: 0.53-0.80]; p<0.001) and ORR (relative risk=1.48 [95% CI: 1.26-1.74]; p<0.001) versus sunitinib. |
| 2021-02-13 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma merck.com ↗
KEYTRUDA plus LENVIMA demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS; HR=0.39 [95% CI: 0.32-0.49]; p<0.001), overall survival (OS; HR=0.66 [95% CI: 0.49-0.88]; p=0.005) and objective response rate (ORR; relative risk=1.97 [95% CI: 1.69-2.29]; p<0.001) versus sunitinib. |
| 2021-02-13 | Exelixis | Results Exelixis Highlights Positive Results for CABOMETYX® (cabozantinib) in Patients with Metastatic Papillary Renal Cell Carcinoma in SWOG S1500/PAPMET Study at ASCO GU exelixis.com ↗
Median PFS was 9.0 months (95% CI: 6-12) with CABOMETYX (n=44) versus 5.6 months (95% CI: 3-7) with sunitinib (n=46) (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.37 to 0.97; p=0.019). |
| 2021-02-08 | Ipsen | Results New data from pivotal Phase III CheckMate -9ER trial of Cabometyx® in combination with Opdivo® showed significantly improved QoL benefits and sustained superior efficacy versus sunitinib in patients living with aRCC ipsen.com ↗
With a median follow-up of two years, Cabometyx® in combination with Opdivo® continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib1 |
| 2021-02-08 | Bristol-Myers Squibb | Results OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma in the Phase 3 CheckMate -9ER Trial bms.com ↗
With a median follow-up of two years, OPDIVO in combination with CABOMETYX continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib |
| 2021-02-08 | Exelixis | Results OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma in the Phase 3 CheckMate -9ER Trial exelixis.com ↗
With a median follow-up of two years, OPDIVO in combination with CABOMETYX continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib |
| 2021-02-05 | Ipsen | Results Ipsen to showcase commitment to going beyond traditional outcome measures for patients living with renal cell carcinoma at ASCO GU 2021 ipsen.com ↗
Highlights include extended follow-up and health-related quality of life data from the pivotal CheckMate -9ER trial, further supporting superiority of Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib in first-line advanced RCC1,2 |
| 2020-11-10 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients… merck.com ↗
LENVIMA plus everolimus also met the trial’s primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. |
| 2020-11-10 | Eisai Inc. | Results LENVIMA® Plus KEYTRUDA® Demonstrated Statistically Significant Improvement in Progression-Free Survival, Overall Survival and Objective Response Rate Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma LENVIMA® Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib Results of Investigational Phase 3 CLEAR Trial (Study 307)/KEYNOTE-581 to be Presented at Upcoming Medical Meeting eisai.com ↗
LENVIMA plus everolimus also met the trial’s primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. |
| 2020-09-19 | Ipsen | Results ESMO 2020: Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) demonstrates significant survival benefits in patients with advanced renal cell carcinoma in pivotal Phase III CheckMate -9ER trial ipsen.com ↗
Cabometyx® in combination with Opdivo® showed superior overall survival and doubled median progression-free survival and objective response rate versus sunitinib, and had a favorable safety profile |
| 2020-09-19 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial bms.com ↗
Opdivo in combination with CABOMETYX showed superior overall survival and doubled median progression-free survival and objective response rate with a favorable safety profile vs. sunitinib |
| 2020-09-19 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial exelixis.com ↗
In patients receiving Opdivo in combination with CABOMETYX, median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months vs. 8.3 months, respectively (HR 0.51; 95% CI: 0.41 to 0.64; p<0.0001). |
| 2020-09-17 | Bristol-Myers Squibb | Results Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
With the longest follow-up for an immunotherapy-based combination in previously untreated advanced RCC, Opdivo plus Yervoy continued to show superior, long-term overall survival (OS) and durable responses compared to sunitinib. |
| 2020-08-18 | Mendus | Results Immunicum AB (publ) Announces Update on Survival Data from Phase II MERECA Trial of Ilixadencel in Kidney Cancer mendus.com ↗
Based on the updated survival data, the final median OS value was reached in the sunitinib control group, while the median OS has not yet been reached in the ilixadencel treatment group. |
| 2020-06-16 | Mendus | Results Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, Immunotherapy mendus.com ↗
The same two patients also exhibited stable disease for 9 months (on third line regorafenib) and 12 months (on second line sunitinib), respectively, based on the modified RECIST criteria. |
| 2020-05-29 | Hutchison Medipharma Limited | Results Chi-Med to Discuss Select Global Clinical Trial Data Presented at ASCO20 hutch-med.com ↗
Savolitinib vs. sunitinib study in PRCC patients demonstrated 27% vs. 7% ORR, with no savolitinib responding patients with disease progression at data cut-off, and encouraging overall survival hazard ratio of 0.51 with median not reached |
| 2020-04-22 | Ipsen | Results Ipsen reports solid sales growth in first quarter 2020 with limited COVID-19 impact ipsen.com ↗ |
| 2020-04-20 | Ipsen | Results Ipsen announces positive topline results from pivotal Phase III CheckMate -9ER trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) in previously untreated advanced renal cell carcinoma ipsen.com ↗
Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib |
| 2020-04-20 | Bristol-Myers Squibb | Results Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma bms.com ↗
Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib |
| 2020-04-20 | Exelixis | Results Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib |
| 2020-02-15 | Bristol-Myers Squibb | Results Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 42-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
Updated results from CheckMate -214 study show that more than 50% of patients treated with Opdivo plus Yervoy were alive at 42 months compared to 39% of patients treated with sunitinib |
| 2019-09-25 | Mendus | Results Immunicum AB (publ) Announces Complete Topline Data Analysis from Phase II MERECA Trial mendus.com ↗
The median Duration of Response was 7.1 months for the ilixadencel combination group versus 2.9 months in the sunitinib monotherapy group over the 18 months study period |
| 2019-08-29 | Mendus | Results Immunicum AB (publ) Announces Positive Phase II MERECA Topline Results Including Complete Tumor Responses in Metastatic Renal Cell Carcinoma Patients mendus.com ↗ |
| 2019-02-16 | Merck KGaA, Darmstadt, Germany | Results Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in the New England Journal of Medicine prnewswire.com ↗
Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). |
| 2019-02-16 | Pfizer | Results Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in The New England Journal of Medicine pfizer.com ↗
Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). |
| 2019-02-16 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) Reduced Risk of Death by Nearly Half Compared to Sunitinib as First-Line Treatment for Advanced Renal Cell Carcinoma (RCC) merck.com ↗
This is the first combination regimen to significantly improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib. |
| 2019-02-11 | Merck Sharp & Dohme LLC | Results Merck Highlights Breadth of Immuno-Oncology Research Program in Genitourinary Cancers at ASCO GU merck.com ↗
Results across OS, PFS and ORR were consistent across all IMDC risk groups and regardless of PD-L1 expression. |
| 2019-02-11 | Bristol-Myers Squibb | Results Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
The 30-month OS rate for the intermediate- and poor-risk population was 60% for patients treated with Opdivo plus low-dose Yervoy versus 47% for patients treated with sunitinib [Hazard Ratio (HR) 0.66 (95% Confidence Interval [CI]: 0.54, 0.80); p < 0.0001]. |
| 2018-12-20 | Hutchison Medipharma Limited | Results Chi-Med Announces Progress in Savolitinib Lung Cancer Program and Update on Kidney Cancer Strategy hutch-med.com ↗
Sutent® (sunitinib) (VEGFR TKI) in first-line PRCC was effective, providing similar tumor control across MET positive and negative patients. |
| 2018-10-22 | Bristol-Myers Squibb | Results Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
With a minimum follow-up of 30 months, 36% of patients who received Opdivo plus Yervoy were still alive and not requiring subsequent therapy vs. 16% of patients who received sunitinib. |
| 2018-09-11 | Pfizer | Results BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Significantly Improved Progression-Free Survival in Previously Untreated Patients with Advanced Renal Cell Carcinoma in Phase III Study pfizer.com ↗
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO® (avelumab) in combination with INLYTA® (axitinib), compared with SUTENT® (sunitinib) as initial therapy for patients with advanced renal cell carcinoma (RCC). |
| 2018-02-23 | Pfizer | Regulatory Pfizer Announces Update on European Marketing Authorization Application for SUTENT® (sunitinib) in Adult Patients at High Risk of Recurrent Renal Cell Carcinoma pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against expanding use of SUTENT® (sunitinib) to include the adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). |
| 2018-02-06 | Hoffmann-La Roche | Results Phase III IMmotion151 study showed Roche's TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) reduced the risk of disease worsening or death by 26 percent in certain people with advanced kidney cancer roche.com ↗ |
| 2018-02-05 | Genentech, Inc. | Results Phase III IMmotion151 Study Showed Genentech’s TECENTRIQ (Atezolizumab) and Avastin (Bevacizumab) Reduced the Risk of Disease Worsening or Death by 26 Percent in Certain People with Advanced Kidney Cancer gene.com ↗
Those who received TECENTRIQ plus Avastin had a 26-percent reduced risk of disease worsening or death (PFS) compared to people treated with sunitinib (median PFS [mPFS]: 11.2 vs. 7.7 months; HR=0.74; 95 percent CI 0.57, 0.96; p=0.02). |
| 2017-12-11 | Hoffmann-La Roche | Results Phase III IMmotion151 study showed Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death for the initial treatment of certain people with advanced kidney cancer roche.com ↗
Tecentriq and Avastin showed improvement in investigator-assessed progression-free survival (PFS) compared with sunitinib for people whose disease expressed PD-L1 |
| 2017-12-10 | Genentech, Inc. | Results Phase III IMmotion151 Study Showed Genentech’s Tecentriq (Atezolizumab) and Avastin (Bevacizumab) Reduced the Risk of Disease Worsening or Death for the Initial Treatment of Certain People with Advanced Kidney Cancer gene.com ↗
TECENTRIQ and Avastin showed improvement in investigator-assessed progression-free survival (PFS) compared with sunitinib for people whose disease expressed PD-L1 |
| 2017-11-16 | Pfizer | Regulatory Pfizer Receives FDA Approval for SUTENT® (sunitinib malate) as First and Only Adjuvant Treatment for Adult Patients at High Risk of Recurrent Renal Cell Carcinoma pfizer.com ↗ |
| 2017-11-07 | Bristol-Myers Squibb | Results Opdivo Plus Yervoy Combination Delivered Overall Survival Benefit Across PD-L1 Expression Levels in Intermediate- and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
Results also show that patients reported significantly better kidney cancer symptom control in the Opdivo (nivolumab) plus Yervoy (ipilimumab) arm compared to the sunitinib arm |
| 2017-09-19 | Pfizer | Regulatory Pfizer Announces Outcome of FDA Advisory Committee Meeting for SUTENT® in Patients at High Risk of Recurrent Renal Cell Carcinoma after Surgery pfizer.com ↗
today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) |
| 2017-09-10 | Bristol-Myers Squibb | Results Opdivo Plus Yervoy Combination Demonstrated Superior Overall Survival and Showed Durable Responses in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma in Phase 3 CheckMate -214 Trial bms.com ↗
Opdivo (nivolumab) plus Yervoy (ipilimumab) reduced the risk of death by 37% versus standard of care, sunitinib, in intermediate- and poor-risk patients |
| 2017-09-09 | Exelixis | Results Exelixis and Ipsen Announce Results from Phase 2 CABOSUN Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma at ESMO 2017 exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced updated results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). |
| 2017-09-07 | Bristol-Myers Squibb | Results CheckMate -214 Study Evaluating Opdivo in Combination with Yervoy Stopped Early for Demonstrating Overall Survival Benefit in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that a Phase 3 study evaluating Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) met its co-primary endpoint, demonstrating superior overall survival (OS) compared to sunitinib in intermediate- and poor-risk patients. |
| 2017-08-15 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Announces Topline Results from CheckMate -214, a Phase 3 Study of Opdivo in Combination with Yervoy in Intermediate and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma bms.com ↗
The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR versus 26.5% for sunitinib. |
| 2017-06-19 | Exelixis | Results Exelixis Announces Independent Radiology Committee Review Confirms Results from CABOSUN, the Phase 2 Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. |
| 2017-05-31 | Pfizer | Regulatory Pfizer Announces Acceptance of Regulatory Submissions by U.S. FDA and European Medicines Agency for SUTENT® (sunitinib) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that a supplemental New Drug Application (sNDA) for SUTENT® (sunitinib) has been accepted for filing by the U.S. Food and Drug Administration (FDA). |
| 2017-02-18 | Hoffmann-La Roche | Results Phase II study supports potential for Roche’s TECENTRIQ (atezolizumab) plus Avastin (bevacizumab) for people with locally advanced or metastatic renal cell carcinoma roche.com ↗
No PFS advantage was observed compared to sunitinib in the intention-to-treat [ITT] population (mPFS: 11.7 vs. 8.4 months; HR = 1.00; 95% CI 0.69, 1.45). |
| 2017-02-17 | Genentech, Inc. | Results Phase II Study Supports Potential for Genentech’s Tecentriq® (Atezolizumab) Plus Avastin® (Bevacizumab) for People with Locally Advanced or Metastatic Renal Cell Carcinoma gene.com ↗
Study results also showed encouraging efficacy compared to sunitinib in those people whose disease expressed the PD-L1 (programmed death-ligand 1) protein |
| 2016-10-10 | Exelixis | Results Exelixis Announces Positive Results from Phase 2 CABOSUN Trial of Cabozantinib Versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma Presented at ESMO 2016 exelixis.com ↗
The median progression-free survival (PFS) for cabozantinib was 8.2 months versus 5.6 months for sunitinib, corresponding to a 2.6 months (46 percent) improvement favoring cabozantinib over sunitinib. |
| 2016-10-09 | Pfizer | Results First Positive Phase 3 Results In Adjuvant Setting For Renal Cell Carcinoma Show SUTENT® (sunitinib) Extended Disease Free Survival After Surgical Removal pfizer.com ↗
The trial showed SUTENT extended disease-free survival (DFS) by more than one year versus placebo in patients who were at high risk for recurrence after surgical resection of renal cell carcinoma (RCC) (HR 0.761; P=0.030 [95% CI: 0.594-0.975]). |
| 2016-07-08 | Pfizer | Results Pfizer Announces Positive Top-Line Results From Phase 3 S-TRAC Trial of SUTENT® (sunitinib) as Adjuvant Therapy in Patients at High Risk of Recurrent Renal Cell Carcinoma pfizer.com ↗
The S-TRAC trial is the first RCC trial of a tyrosine kinase inhibitor (TKI) to prolong DFS in the adjuvant setting. |
| 2016-05-23 | Exelixis | Results Exelixis Announces Results from Randomized Phase 2 Trial CABOSUN Demonstrate Cabozantinib Significantly Improved Progression-Free Survival versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for cabozantinib compared with sunitinib in patients with advanced intermediate- or poor-risk RCC. |
| 2015-09-27 | Immatics Biotechnologies GmbH | Results Immatics announces results of IMPRINT phase 3 clinical trial investigating the addition of IMA901 to standard first-line therapy with sunitinib for advanced/metastatic RCC immatics.com ↗
The phase 3 trial did not meet its primary endpoint of showing an overall survival benefit of IMA901 in combination with sunitinib compared with sunitinib alone in this patient population. |
| 2014-05-21 | Mendus | Results Immunicum reports preliminary regression data after add-on therapy with tyrosine kinase inhibitors and continued compelling survival data from the formally completed phase I/II-study in renal cell … mendus.com ↗
In one case, a patient had four brain metastases of which two have gone into complete remission and the remaining two into a continued extensive partial regression. |
| 2014-04-01 | GlaxoSmithKline | Results Results from phase III patient preference study of GSK’s Votrient® (pazopanib) vs. Sutent® (sunitinib) in advanced renal cell carcinoma published in Journal of Clinical Oncology gsk.com ↗
The results showed that 70% (95%* CI, 60.9–78.4) of patients expressed a preference for pazopanib compared to 22% (95%* CI, 14.7–30.6) expressing a preference for sunitinib, as assessed by a questionnaire. |
All press releases naming this drug 81 releases
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 444 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sunitinib | “Days -13 (or -7) to day 0 (total 7 or 14 days) - oral sunitinib daily Cycle 1: day 1 - Cycle 1 AC (60/600mg/m2); days 15-21 - oral sunitinib daily Cycle 2: day 1 - Cycle 2 AC...” NCT01176799 ↗403“This trial will be conducted to assess the activity of Sunitinib in patients affected by advanced or recurrent B3 thymoma or thymic carcinoma progressing after at least one...” NCT03449173 ↗ “In total, 136 patients will be randomized in a 2:1 ratio to [177Lu]Lu-DOTATATE (≤4 doses of 7.4 GBq given every 4 wk) or local standard of care (hydroxyurea, bevacizumab,...” PMID 40774695 ↗ Jan 2026 “Participants with PDGFRA gene mutations will receive a drug called sunitinib, which inhibits some proteins that are thought to be key factors in the development and progression...” NCT02208583 ↗ “A Phase I Dose Escalation Study With Sunitinib (SutentR) in Combination With Capecitabine and Irinotecan (Capiri) in Previously Treated Patients With Advanced Colorectal Cancer” NCT00777478 ↗ “Sunitinib (SUTENT) is a potent tyrosine kinase inhibitor, with double antiangiogenic and antitumor activity, targeting multiple receptors as VEGF-R, PDGF-R, KIT and FLT3.” NCT01215565 ↗ “Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity” NCT00265317 ↗ “Within the SOC arm, patients received single-agent bevacizumab (19), axitinib (18), everolimus (7), pazopanib (4), sorafenib (4), sunitinib (2), or temsirolimus (2).” PMID 28950297 ↗ Nov 2017 “Immediate CN followed by sunitinib therapy vs treatment with 3 cycles of sunitinib followed by CN in the absence of progression followed by sunitinib therapy.” PMID 30543350 ↗ Feb 2019 “Results of the ADAPT Phase 3 Study of Rocapuldencel-T in Combination with Sunitinib as First-Line Therapy in Patients with Metastatic Renal Cell Carcinoma.” PMID 32034074 ↗ Feb 2020 “Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial.” PMID 17046465 ↗ Oct 2006 |
| Known as | NSC 736511 | “Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study” NCT00453154 ↗1“A Phase II Evaluation of Sunitinib Malate (Sutent®, SU11248, NCI-Supplied Agent , NSC # 736511) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus” NCT00378911 ↗ |
| Known as | NSC-750690 | ChEMBL registry synonym — accepted as the source's own label CHEMBL535 ↗ |
| Known as | PHA-290940AD | ChEMBL registry synonym — accepted as the source's own label CHEMBL535 ↗ |
| Known as | SU 11248 | “Sunitinib (SU 11248) is a small molecule with good oral bioavailability that inhibits multiple receptor tyrosine kinases (RTKs) expressed on diverse tumour cells: VEGFR, PDGFR,...” NCT01100177 ↗6“A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breast” NCT00482755 ↗ “An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma” NCT01216657 ↗ “SUTENT (SUNITINIB, SU11248) is a potent multi-target inhibitor of VEGFR1-3, PDGFR-α/β, FLT3, c-KIT, RET and CSF-1R.” NCT00535379 ↗ “A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain” NCT00462982 ↗ |
| Known as | SU-010398 | ChEMBL registry synonym — accepted as the source's own label CHEMBL535 ↗ |
| Known as | SU-011248 L-MALATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL535 ↗ |
| Known as | SU011248 | “A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED...” NCT01525550 ↗37“The Influence of Genotype/Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib (Sutent, SU011248) in Patient With Imatinib Resistant...” NCT01743300 ↗ “A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer...” NCT00457392 ↗ “SU011248 is an orally administered inhibitor of the vascular endothelial growth factor (VEGF) receptors, platelet-derived growth factor (PDGF) receptor, FLT-3 and c-KIT.” NCT00299741 ↗ “A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer” NCT00338884 ↗ “Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors” NCT00428597 ↗ “Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg” NCT00226811 ↗ “Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma” NCT00589784 ↗ “Sunitinib Malate (SU011248)” NCT00706706 ↗ “Sunitinib Malate (SU011248)” NCT00793871 ↗ “Sunitinib (SU011248)” NCT00550810 ↗ |
| Known as | SU011248, Sutent | “SU011248, Sutent” NCT00247676 ↗ |
| Known as | SU011248-Sutent-Sunitinib | “SU011248-Sutent-Sunitinib” NCT00611728 ↗ |
| Known as | SU11248 is also known as Sutent | “SU11248 is also known as Sutent” NCT00304200 ↗ |
| Known as | SUN | “Sunitinib (SUN)-induced hypoxia within the tumor could promote the activation of the prodrug evofosfamide (EVO), locally releasing the cytotoxic DNA alkylator...” PMID 34190375 ↗ Jul 20211“Our main comparator was sunitinib (SUN).” PMID 37146227 ↗ May 2023 |
| Known as | Sunitinib accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL535 ↗ |
| Known as | Sunitinib l-malate | ChEMBL registry synonym — accepted as the source's own label CHEMBL535 ↗ |
| Known as | Sunitinib malate | “A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED...” NCT01525550 ↗55“Sunitinib malate is an orally administered small molecule that inhibits the tyrosine kinase enzymatic activities of the receptors for VEGF and PDGF, and also blocks signalling...” NCT01731925 ↗ “To assess the efficacy (objective response rate) of sunitinib (sunitinib malate) given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced...” NCT00389974 ↗ “sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or...” NCT00375674 ↗ “To evaluate the anti-tumor activity of SU11248 (sunitinib malate), a highly potent, selective tyrosine kinases inhibitor, in patients with persistent or recurrent clear cell...” NCT00979992 ↗ “This is a phase II study to evaluate the effectiveness of study drug sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas of the salivary gland.” NCT00886132 ↗ “This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer.” NCT00411151 ↗ “Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with other regimens in similar settings.” NCT00730353 ↗ “RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.” NCT01024205 ↗ “OBJECTIVES: Primary * Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients with unresectable hepatocellular carcinoma.” NCT00514228 ↗ “Sunitinib malate capsule 50mg administered orally, once daily in 28-day cycle(14 days on treatment from Day 1-14, 14 days off treatment from day 15-28).” NCT04523272 ↗ |
| Known as | Sunitinib malate (suntinib; SU11248, SU011248, Sutent) | “Sunitinib malate (suntinib; SU11248, SU011248, Sutent®)” NCT00843037 ↗ |
| Known as | Sunitinib maleate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00891475 ↗ |
| Known as | Sunitinib, NSC 736511, Sutent | “Sunitinib, NSC 736511, Sutent” NCT00961571 ↗ |
| Known as | SUO11248 | “This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.” NCT00393796 ↗1“Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)” NCT00495625 ↗ |
| Known as | SUTENT | “Sunitinib (Sutent®; Pfizer, New York, NY, USA) is a multitargeted tyrosine-kinase inhibitor (TKI) with activity against the stem cell-factor receptor (KIT) and platelet-derived...” NCT02623127 ↗22“A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With...” NCT00491738 ↗ “Sunitinib (SUTENT) is a potent tyrosine kinase inhibitor, with double antiangiogenic and antitumor activity, targeting multiple receptors as VEGF-R, PDGF-R, KIT and FLT3.” NCT01215565 ↗ “The THYSU trial is a phase II trial of sunitinib (Sutent) in patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma.” NCT00510640 ↗ “sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year” NCT01164202 ↗ “This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere).” NCT00712504 ↗ “Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors” NCT00428597 ↗ “A Phase II Study of SUNITINIB MALATE (Sutent) and Chemoembolization in Patients With Unresectable Hepatocellular Cancer” NCT00524316 ↗ “the present study will investigate the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously” NCT00748358 ↗ “Study of Sutent®/Sunitinib (SU11248) in Subjects With NF-1 Plexiform Neurofibromas” NCT01402817 ↗ “sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.” NCT00400114 ↗ |
| Known as | SUTENT (REGISTERED) | “A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED...” NCT01525550 ↗ |
| Known as | Sutent(R) | “Sunitinib (Sutent(R)) is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and gastrointestinal stromal tumors.” NCT00402415 ↗ |
| Known as | Sutent, sunitinib | “SUTENT (Sunitinib)” NCT01054911 ↗1“Sutent, sunitinib” NCT00471276 ↗ |
| Action | Inhibit | “Platelet-derived growth factor receptor alpha inhibitor” CHEMBL535 ↗6“Vascular endothelial growth factor receptor 2 inhibitor” CHEMBL535 ↗ “Vascular endothelial growth factor receptor 3 inhibitor” CHEMBL535 ↗ “Vascular endothelial growth factor receptor 1 inhibitor” CHEMBL535 ↗ “Macrophage colony stimulating factor receptor inhibitor” CHEMBL535 ↗ “Platelet-derived growth factor receptor beta inhibitor” CHEMBL535 ↗ “sunitinib, a multitargeted tyrosine kinase inhibitor” PMID 17046465 ↗ Oct 2006 |
| Modality | Small molecule | “an Oral Multi-Targeted Tyrosine Kinase Inhibitor” NCT00392496 ↗ |
| Route | Oral | “by oral capsule” NCT00056693 ↗ |
| Target | CSF1R | “Macrophage colony stimulating factor receptor inhibitor” CHEMBL535 ↗ |
| Target | FLT1 | “Vascular endothelial growth factor receptor 1 inhibitor” CHEMBL535 ↗ |
| Target | FLT4 | “Vascular endothelial growth factor receptor 3 inhibitor” CHEMBL535 ↗ |
| Target | KDR | “Vascular endothelial growth factor receptor 2 inhibitor” CHEMBL535 ↗ |
| Target | KIT | “SU011248 is an orally administered inhibitor of the vascular endothelial growth factor (VEGF) receptors, platelet-derived growth factor (PDGF) receptor, FLT-3 and c-KIT.” NCT00299741 ↗ |
| Target | PDGFRA | “Platelet-derived growth factor receptor alpha inhibitor” CHEMBL535 ↗ |
| Target | PDGFRB | “Platelet-derived growth factor receptor beta inhibitor” CHEMBL535 ↗ |