Drugs / Cobimetinib
Cobimetinib
also known as
GDC-0973 · Cob · Cobimetinib = code number RO5514041/F04 · COBIMETINIB FUMARATE · Cobimetinib hemifumarate · Cotellic · Gdc-0973 hemifumarate · RG 7420 · +2 more
Small molecule targets MAP2K1, MAP2K2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed melanomatosis 2 milestones | |||||
| Filed | US (FDA) | — | melanomatosis | 2015-02-18 | “Administration (FDA) has accepted for review Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib” exelixis.com ↗ “Genentech filed its New Drug Application (NDA) for cobimetinib with the U.S. Food and Drug Administration (FDA) in December” exelixis.com ↗ |
| Filed | EU (EMA) | — | melanomatosis | — | “In the European Union, Roche filed a Marketing Authorization Application for cobimetinib used in combination with vemurafenib in September of 2014.” exelixis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | COTELLIC | — | 2018-01-26 – 2022-10-28 | fda.gov ↗ |
| Approved | EU (EMA) | Cotellic | — | 2015-11-20 | europa.eu ↗ |
| Approved | US (FDA) | COTELLIC | — | 2015-11-10 | fda.gov ↗ |
Trials 109 · started per year
today
US approved 2015
EU approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 0 | NCT04005690 | Aug 2019 → Jun 2027 expected | pancreatic ductal adenocarcinoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 131 trials | ||||||
| Phase 1 | NCT05691504 | Sep 2023 → Feb 2027 expected | endometrial carcinoma, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma +1 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05441514 | Apr 2023 → Mar 2026 | acute myeloid leukemia | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT05034627 | Aug 2022 → Dec 2025 overdue | pancreatic adenocarcinoma | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04835805 | May 2021 → Dec 2026 expected | melanoma | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04190628 | Jun 2020 → Apr 2024 | neoplastic disease or syndrome | ABM Therapeutics Corporation | Terminated | 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 | NCT04109456 | Mar 2020 → Dec 2024 | metastatic melanoma | InxMed (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03695380 | Jan 2019 → Jul 2023 | ovarian cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03178851 | Jun 2017 → May 2019 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03284502 | May 2017 → Sep 2024 | metastatic neoplasm | Hanmi Pharmaceutical Company Limited | Unknown | No outcome recorded |
| Phase 1 | NCT02876224 | Sep 2016 → Jun 2019 | colorectal cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02721459 | Sep 2016 → Oct 2019 overdue | melanoma, skin cancer | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02818023 | Jul 2016 → Jun 2019 | melanoma | Yana Najjar | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02670044 | Mar 2016 → Dec 2020 | acute myeloid leukemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02457793 | Jun 2015 → Dec 2016 | colorectal cancer, metastatic melanoma, non-small cell lung carcinoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02300025 | Aug 2014 → Jan 2015 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02136524 | Apr → May 2014 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01974258 | Feb → Jul 2014 | neoplasm | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 1 | NCT01988896 | Dec 2013 → Nov 2019 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01986166 | Nov 2013 → Jan 2016 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01876641 | Oct 2013 → Jun 2018 | metastatic melanoma | Mohammed M Milhem | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01929876 | Jul → Oct 2013 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01711762 | Sep 2012 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01656642 | Aug 2012 → Mar 2020 | melanoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01562275 | Apr 2012 → Jan 2015 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01271803 | Feb 2011 → Oct 2013 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01277718 | Jan → Feb 2011 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01249131 | Dec 2010 → Jan 2011 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01249118 | Nov 2010 → Jan 2011 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00996892 | Nov 2009 → Mar 2014 | cancer | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT00467779 | May 2007 → Apr 2014 | cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/214 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT04216953 | Feb 2020 → Dec 2024 | soft tissue sarcoma | Centre Leon Berard | Completed | No outcome recorded |
| Phase 1/2 | NCT04214418 | Feb 2020 → Apr 2022 | digestive system cancer | Columbia University | Terminated | No outcome recorded |
| Phase 1/2 | NCT03989115 | Jul 2019 → Feb 2022 | cancer | Revolution Medicines, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03732703 | Apr 2019 → Dec 2024 | refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Completed | No outcome recorded |
| Phase 1/2 | NCT03566485 | Jul 2018 → Dec 2020 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT03312530 | Nov 2017 → May 2021 | plasma cell myeloma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03281369 | Oct 2017 → Oct 2025 | digestive system carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03202940 | Sep 2017 → Jan 2029 expected | non-small cell lung carcinoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03193190 | Jul 2017 → Feb 2025 | pancreatic adenocarcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03101254 | Jun 2017 → Oct 2020 | melanoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02639546 | May 2016 → Jul 2021 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT01959633 | Apr 2014 → Mar 2018 | melanoma | Fondazione Melanoma Onlus | Completed | No outcome recorded |
| Phase 1/2 | NCT01928394 | Oct 2013 → Feb 2019 | — | Bristol-Myers Squibb | Completed | Met primary |
| Phase 254 trials · 5 met primary · 2 missed | ||||||
| Phase 2 | NCT07449754 | Feb 2026 → Sep 2029 expected | melanoma | Hanmi Pharmaceutical Company Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT06813079 | Apr 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06440850 | Jul 2024 → Nov 2026 expected | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05756556 | Jun 2024 → Dec 2026 | melanoma | ImmVira Pharma Co. Ltd | Suspended | No outcome recorded |
| Phase 2 | NCT06229340 | Oct 2023 → Oct 2026 expected | colorectal cancer, lung cancer, malignant pancreatic neoplasm, melanoma +1 | N.N. Petrov National Medical Research Center of Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT05125471 | Jul 2022 → Sep 2025 | arteriovenous hemangioma/malformation | University of Arkansas | Completed | No outcome recorded |
| Phase 2 | NCT04941287 | Dec 2021 → Jan 2024 overdue | distal biliary tract carcinoma, gallbladder carcinoma, intrahepatic cholangiocarcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04551521 | Oct 2021 → Dec 2024 | cancer | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT04931342 | Oct 2021 → Feb 2028 expected | ovarian cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04079179 | Apr 2021 → Dec 2025 overdue | Erdheim-Chester disease, Langerhans cell histiocytosis, histiocytic sarcoma, juvenile xanthogranuloma +3 | Carl Allen | Recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04409639 | Jan 2021 → Apr 2025 overdue | chronic myelomonocytic leukemia | University of Utah | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04722575 | Dec 2020 → Dec 2023 overdue | melanoma | Fondazione Melanoma Onlus | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04302025 | Nov 2020 → Nov 2026 expected | non-small cell lung carcinoma | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04185831 | Oct 2020 → Jan 2024 overdue | cancer | Uppsala University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT04341181 | Aug 2020 → Apr 2029 expected | cancer | Ulrik Lassen | Recruiting | No outcome recorded |
| Phase 2 | NCT03625141 | Dec 2018 → Jun 2021 | metastatic melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03600701 | Nov 2018 → Jul 2025 overdue | non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03554083 | Oct 2018 → Apr 2025 | cutaneous melanoma | Mayo Clinic | Completed | Met primary |
| Phase 2 | NCT03363867 | Jul 2018 → Feb 2024 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Peter MacCallum Cancer Centre, Australia | Unknown | No outcome recorded |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT03430947 | Jul 2018 → Feb 2023 | metastatic malignant neoplasm in the brain, metastatic melanoma | Technical University Dresden | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03224208 | May 2018 → Sep 2020 | cutaneous melanoma | Fondazione Melanoma Onlus | Terminated | No outcome recorded |
| Phase 2 | NCT03340558 | May 2018 → Feb 2021 | colorectal cancer | Niharika Mettu | Withdrawn | No outcome recorded |
| Phase 2 | NCT03297606 | Mar 2018 → Dec 2026 expected | non-Hodgkin lymphoma, plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03201458 | Feb 2018 → Aug 2020 | gallbladder carcinoma, intrahepatic cholangiocarcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT03224767 | Jan 2018 → Sep 2023 overdue | papillary craniopharyngioma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03395899 | Dec 2017 → Aug 2023 | estrogen-receptor positive breast cancer | Queen Mary University of London | Completed | No outcome recorded |
| Phase 2 | NCT03264066 | Nov 2017 → Jun 2020 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03202316 | Aug 2017 → Dec 2027 expected | inflammatory breast carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03181100 | Jul 2017 → Jul 2027 expected | poorly differentiated thyroid gland carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma | M.D. Anderson Cancer Center | Active not recruiting | Met primary |
| Phase 2 | NCT03175432 | Jun 2017 → Jun 2028 expected | central nervous system melanocytic neoplasm, cutaneous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03005639 | Jun 2017 → Feb 2018 | melanoma | Inova Health Care Services | Withdrawn | No outcome recorded |
| Phase 2 | NCT03108131 | Apr 2017 → Apr 2024 | appendix adenocarcinoma, metastatic malignant neoplasm, neoplastic syndrome, skin squamous cell carcinoma +1 | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02968303 | Jan 2017 → Oct 2022 | melanoma of soft tissue | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02902029 | Nov 2016 → Mar 2024 | melanoma | University Hospital, Essen | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02768207 | May 2016 → Dec 2017 | metastatic melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | Mixed |
| Phase 2 | NCT02649972 | Jan 2016 → Dec 2022 | histiocytosis | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02537600 | Dec 2015 → Nov 2019 | melanoma | Center Eugene Marquis | Completed | No outcome recorded |
| Phase 2 | NCT02036086 | Aug 2015 → Jan 2024 | melanoma | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| Phase 2 | NCT02583516 | Jun 2015 → Sep 2019 | melanoma | Spanish Melanoma Group | Completed | Missed primary |
| Phase 2 | NCT02291289 | Apr 2015 → May 2019 | colorectal cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02322814 | Mar 2015 → Aug 2018 | breast cancer | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 2 | NCT02230306 | Feb 2015 → Mar 2016 | metastatic melanoma | Melissa Burgess, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02303951 | Jan 2015 → May 2020 | melanoma | University Hospital Tuebingen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02414750 | Dec 2014 → Nov 2020 | metastatic melanoma | Netherlands Working Group on Immunotherapy of Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02091141 | Apr 2014 → May 2023 | biliary tract cancer, salivary gland cancer, urinary bladder cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02060188 | Mar 2014 → Oct 2024 | colorectal cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01495988 | Aug 2013 → Jan 2016 | metastatic melanoma | Melanoma Research Foundation Breakthrough Consortium | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01813214 | Mar 2013 → Aug 2016 | melanoma | Georgetown University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05768178 | Mar 2023 → Oct 2029 expected | Erdheim-Chester disease, colorectal neoplasm, glioma, laryngeal neoplasm +6 | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 35 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT04007848 | Jul 2019 → Oct 2021 | histiocytosis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT03768063 | Feb 2019 → Jul 2028 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03273153 | Dec 2017 → Apr 2019 | melanoma | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 3 | NCT02788279 | Jul 2016 → Mar 2018 | colorectal cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT01689519 | Jan 2013 → May 2014 | melanoma | Hoffmann-La Roche | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT02908672 Background | Jan 2017 → Oct 2019 | melanoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02427893 Comparator | Aug 2015 → Nov 2016 | melanoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2020-10-24 | Revolution Medicines, Inc. | Results Revolution Medicines Reports Progress and Expansion of Combination Strategy with RMC-4630 as Therapeutic Backbone for RAS-Addicted Cancers revmed.com ↗
Interim results suggest that a dual intermittent dosing strategy for RMC-4630 and cobimetinib exceeds target plasma exposures for each drug based on preclinical models of RAS pathway-driven cancers that project potential clinical activity. |
| 2020-07-31 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. |
| 2020-07-30 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma gene.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. |
| 2019-12-13 | Hoffmann-La Roche | Results Roche announces positive Phase III study results for Tecentriq plus Cotellic and Zelboraf in people with previously untreated BRAF V600 mutation-positive advanced melanoma roche.com ↗
The study showed adding Tecentriq® (atezolizumab) to Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf. |
| 2019-12-13 | Exelixis | Results Exelixis Announces Positive Results From IMspire150, the Phase 3 Trial of Atezolizumab Plus Cotellic and Vemurafenib in People With Previously Untreated BRAF V600 Mutation-Positive Advanced Melanoma exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced positive results from IMspire150, the phase 3 trial of atezolizumab (TECENTRIQ®), cobimetinib (COTELLIC®) and vemurafenib (ZELBORAF®) in people with previously untreated BRAF V600 mutation-positive advanced melanoma. |
| 2019-12-12 | Genentech, Inc. | Results Genentech Announces Phase III Study Results for Tecentriq Plus Cotellic and Zelboraf in People With Previously Untreated BRAF V600 Mutation-positive Advanced Melanoma gene.com ↗
The study showed adding Tecentriq® (atezolizumab) to Cotellic ® (cobimetinib) and Zelboraf® (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf. |
| 2018-05-10 | Hoffmann-La Roche | Results Roche provides update on Phase III study of Tecentriq (atezolizumab) and Cotellic (cobimetinib) in people with heavily pre-treated locally advanced or metastatic colorectal cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMblaze370 study evaluating the combination of Tecentriq® (atezolizumab) and Cotellic® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. |
| 2018-05-10 | Exelixis | Results Exelixis Provides Update on IMblaze370 Phase 3 Pivotal Trial of Atezolizumab and Cobimetinib in Patients With Heavily Pretreated Locally Advanced or Metastatic Colorectal Cancer exelixis.com ↗
Genentech, Exelixis’ collaborator and sponsor of the IMblaze370 trial, informed the company that the combination of atezolizumab and cobimetinib did not deliver an improvement in overall survival (OS) versus regorafenib. |
| 2018-05-09 | Genentech, Inc. | Results Genentech Provides Update on Phase III Study Of TECENTRIQ (Atezolizumab) and COTELLIC (Cobimetinib) in People With Heavily Pre-Treated Locally Advanced or Metastatic Colorectal Cancer gene.com ↗
the Phase III IMblaze370 study evaluating the combination of TECENTRIQ® (atezolizumab) and COTELLIC ® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. |
| 2018-01-20 | Exelixis | Results Exelixis Announces Presentation of Updated Phase 1b Results for the Combination of Cobimetinib and Atezolizumab in Metastatic Colorectal Cancer at the 2018 American Society of Clinical Oncology Gastrointestinal Cancers Symposium exelixis.com ↗
In addition, the combination demonstrated a median 13-month overall survival as well as durable responses in patients with microsatellite-stable tumors, which have historically been resistant to immunotherapy administered on its own. |
| 2017-06-03 | Hoffmann-La Roche | Results Roche presents new data for TECENTRIQ® (atezolizumab) and updates from across its cancer immunotherapy development programme at ASCO 2017 roche.com ↗
Two Phase Ib studies in melanoma combining TECENTRIQ plus Cotellic® (cobimetinib) and TECENTRIQ plus Cotellic plus Zelboraf® (vemurafenib) showed that the addition of Zelboraf and/or Cotellic may alter the tumour micro environment, enhancing the an |
| 2016-11-07 | Exelixis | Results Exelixis Announces Presentation of Cobimetinib Combination Therapy Data at the Society for Melanoma Research 2016 Congress That Support Genentech’s Planned Phase 3 Pivotal Trials exelixis.com ↗
Additionally, data from a pooled analysis of the combination of cobimetinib and vemurafenib demonstrate the potential for the combination to deliver lasting clinical benefit. |
| 2016-10-07 | Exelixis | Results Exelixis Announces Genentech Presentation of Preliminary Phase 1b Results for the Combination of Cobimetinib, Vemurafenib and Atezolizumab at ESMO 2016 Congress exelixis.com ↗
The preliminary results to be presented at the ESMO Congress suggest that adding atezolizumab to the combination regimen is associated both with a manageable safety profile and promising antitumor activity. |
| 2016-06-05 | Exelixis | Results Exelixis Announces Genentech Presentation of Preliminary Phase 1B Trial Results for the Combination of Cobimetinib and Atezolizumab at ASCO 2016 Annual Meeting exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that its collaborator Genentech, a member of the Roche Group, will present preliminary results from a phase 1b clinical trial evaluating the safety and clinical activity of cobimetinib, an Exelixis-discovered MEK inhibitor, in combination with atezolizumab, an anti-PD-L1 antibody discovered and developed by Genentech, in patients with metastatic colorectal cancer (CRC). |
| 2015-11-25 | Exelixis | Regulatory Exelixis Announces European Commission Approval of COTELLIC™ (Cobimetinib) for Use in Combination with Vemurafenib in Advanced BRAF V600 Mutation-Positive Melanoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission (EC) has approved COTELLIC™ (cobimetinib) for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
| 2015-11-21 | Genentech, Inc. | Results Updated Data Showed That Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) Helped People With a Specific Type of Advanced Melanoma Live Significantly Longer Than With Zelboraf Alone gene.com ↗
Cotellic plus Zelboraf reduced the risk of death by 30 percent compared to Zelboraf alone and helped people live a median of nearly two years (median OS 22.3 months vs. 17.4 months, hazard ratio [HR]=0.70, 95 percent CI: 0.55-0.90, p=0.005). |
| 2015-11-21 | Exelixis | Results Exelixis Announces Presentation of Positive Overall Survival Results for COTELLIC™ in Combination with Vemurafenib in Advanced BRAF V600 Mutation-Positive Melanoma at Society for Melanoma Research 2015 International Congress exelixis.com ↗
Today’s presentation was the first to include detailed data on the endpoint. |
| 2015-11-10 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma gene.com ↗
FDA Approves Genentech’s Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma |
| 2015-11-10 | Exelixis | Regulatory FDA Approves COTELLIC™ (Cobimetinib) for use in Combination with Vemurafenib to Treat Advanced Melanoma exelixis.com ↗
Exelixis, Inc. (Nasdaq:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved COTELLIC™ (cobimetinib) as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib. |
| 2015-10-06 | Exelixis | Results Exelixis Announces Positive Overall Survival Results from Phase 3 Pivotal Trial of Cobimetinib in Combination with Vemurafenib in Patients with BRAF V600 Mutation-Positive Advanced Melanoma exelixis.com ↗ |
| 2015-09-25 | Exelixis | Regulatory European CHMP Adopts Positive Opinion for Cobimetinib in Combination with Vemurafenib for the Treatment of Advanced Melanoma exelixis.com ↗ |
| 2015-08-27 | Exelixis | Regulatory Exelixis Announces First Regulatory Approval of Cobimetinib in Switzerland exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that Swissmedic, the Swiss licensing and supervisory authority of Switzerland, has approved cobimetinib for use in combination with vemurafenib as a treatment for patients with advanced melanoma. |
| 2015-07-01 | Exelixis | Regulatory Exelixis Provides Update on Genentech’s Pending New Drug Application for Cobimetinib, an Exelixis-Discovered Compound exelixis.com ↗
FDA extended its review after Genentech submitted, at FDA request, additional data from coBRIM, the phase 3 registrational trial of cobimetinib and vemurafenib in patients with BRAF V600 mutation-positive advanced melanoma. |
| 2015-05-30 | Genentech, Inc. | Results Updated Data Showed Genentech’s Investigational Combination of Cobimetinib and Zelboraf (Vemurafenib) Helps People With Advanced Melanoma Live for a Year Without Their Disease Worsening gene.com ↗
The combination of cobimetinib and Zelboraf extended the time people lived without their disease getting worse to a year, |
| 2015-05-30 | Exelixis | Results Updated Positive Results from Two Trials of Cobimetinib in Combination with Vemurafenib for the Treatment of Patients with Advanced Melanoma Presented at 2015 ASCO Annual Meeting exelixis.com ↗
Exelixis Inc. (NASDAQ:EXEL) today announced updated positive results for cobimetinib, an Exelixis-discovered investigational compound, in combination with vemurafenib for the treatment of patients with previously untreated BRAF V600 mutation-positive advanced melanoma. |
| 2015-02-19 | Exelixis | Regulatory Exelixis Announces Acceptance of New Drug Application for Cobimetinib in Combination with Vemurafenib for Treatment of Patients with BRAF V600 Mutation-Positive Advanced Melanoma exelixis.com ↗
FDA has granted Priority Review to the NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 11, 2015. |
| 2015-02-18 | Genentech, Inc. | Regulatory FDA Grants Genentech's Cobimetinib Priority Review for Use in Combination with Zelboraf (Vemurafenib) in Advanced Melanoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. |
| 2014-12-15 | Exelixis | Regulatory Exelixis’ Collaborator Genentech Files New Drug Application for the Combination of Cobimetinib and Vemurafenib for the Treatment of Patients With BRAF V600 Mutation-Positive Advanced Melanoma exelixis.com ↗
Genentech, a member of the Roche Group, has completed the filing of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) |
| 2014-09-29 | Exelixis | Results Exelixis Announces Positive Results from Phase 3 Pivotal Trial of Cobimetinib in Combination with Vemurafenib in Patients with BRAF V600 Mutation-Positive Advanced Melanoma exelixis.com ↗ |
| 2014-07-14 | Exelixis | Results Exelixis Announces Positive Top-Line Results for Phase 3 Pivotal Trial of Cobimetinib in Combination With Vemurafenib in Patients With BRAF V600 Mutation-Positive Advanced Melanoma exelixis.com ↗
Exelixis’ collaborator Genentech, a member of the Roche Group, informed the company that coBRIM met its primary endpoint, delivering a statistically significant increase in progression-free survival (PFS) for the combination of cobimetinib plus vemurafenib as compared to vemurafenib alone. |
| 2014-05-07 | Exelixis | Results Exelixis Announces Presentation of Final Phase 1b Data for Cobimetinib in Combination with Vemurafenib at EADO Congress 2014 exelixis.com ↗ |
| 2013-09-28 | Exelixis | Results Exelixis Announces Presentation of Updated Phase 1b Data for Cobimetinib (GDC-0973/XL518) in Combination with Vemurafenib at ECC 2013 exelixis.com ↗
“The data presented today, while early-stage, suggest that the preliminary safety profile and activity of the investigational combination of cobimetinib and vemurafenib is promising in BRAFi-naïve patients,” said Michael Morrissey, Ph.D., president and CEO of Exelixis. |
| 2012-09-29 | Exelixis | Results Exelixis Announces Data Presentation for GDC-0973 (XL518) exelixis.com ↗
The results of the study were also highlighted in an ESMO press briefing. |
All press releases naming this drug 39 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 113 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cobimetinib | “Comparing Oral to Intravenous Administration of GDC-0973 (Cobimetinib)” NCT01249118 ↗108“Cobimetinib 60 mg on days 1-21, break 7 days, cycle 28 days orally” NCT06229340 ↗ |
| Known as | Cob | “cobimetinib (Cob) 60 mg IV once daily, 21 days on/7 days off schedule (21/7).” NCT01656642 ↗ |
| Known as | Cobimetinib = code number RO5514041/F04 | “Cobimetinib = code number RO5514041/F04” NCT02537600 ↗ |
| Known as | COBIMETINIB FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | Cobimetinib hemifumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | Cotellic | “Zelboraf + Cotellic used outside of indication, based on biomarker” NCT04817956 ↗ |
| Known as | GDC-0973 | “Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.” NCT01813214 ↗ |
| Known as | Gdc-0973 hemifumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | RG 7420 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | Xl-518 hemifumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | XL518 | “Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.” NCT01813214 ↗ |
| Action | Inhibit | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL2146883 ↗1“MEK inhibition with cobimetinib” PMID 25037139 ↗ Jul 2014 |
| Modality | Small molecule | “small-molecule inhibitor” NCT03395899 ↗ |
| Route | Oral | “Repeating oral dose” NCT00467779 ↗ |
| Target | MAP2K1 | “cobimetinib (GDC-0973), a highly selective inhibitor of MEK1” NCT02414750 ↗ |
| Target | MAP2K2 | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL2146883 ↗ |