Drugs / Sotorasib
Sotorasib
also known as
AMG510 · (S)-AMG-510 · CT-AMG510AMG-510AMG510 · KRAS G12C INHIBITOR 9 · KRAS MUTANT-TARGETING AMG 510 · LUMAKRAS · LUMYKRAS · SOTORASIB (AMG510) RACEMATE
Small molecule targets KRAS via inhibition
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 6 milestones | |||||
| Filed | EU (EMA) | — | non-small cell lung carcinoma | 2021-09-08 | “has submitted an MAA in the EU” amgen.com ↗ |
| Filed | Japan (PMDA) | — | non-small cell lung carcinoma | 2021-09-08 | “has submitted an MAA in the EU and New Drug Applications in Japan (J-NDA)” amgen.com ↗ |
| Filed | Other | — | non-small cell lung carcinoma | 2021-09-08 | “through the initiative, has submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia , Brazil , Canada and the United Kingdom” amgen.com ↗ “Additionally, Amgen has submitted an MAA in the EU and New Drug Applications in Japan (J-NDA), Switzerland , South Korea and United Arab Emirates” amgen.com ↗ “has submitted an MAA in the EU and New Drug Applications in Japan (J-NDA), Switzerland , South Korea , Singapore , Israel , Turkey and Taiwan” amgen.com ↗ “Through Project Orbis , Amgen also has Marketing Authorization Applications (MAAs) for sotorasib in review in Israel and Singapore .” amgen.com ↗ “Amgen also has Marketing Authorization Applications (MAAs) for sotorasib in review in Australia, Brazil, Singapore, and Israel.” amgen.com ↗ “has submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia , Brazil , Canada and the United Kingdom” amgen.com ↗ “Additionally, Amgen submitted MAAs for sotorasib in Australia , Brazil , Canada and the United Kingdom in January 2021” amgen.com ↗ “Additionally, Amgen submitted MAAs for sotorasib in Australia , Brazil , Canada and the United Kingdom in Jan. 2021” amgen.com ↗ “Additionally, Amgen has submitted an MAA in the EU and New Drug Applications in Japan (J-NDA), Switzerland” amgen.com ↗ |
| Filed | EU (EMA) | — | non-small cell lung carcinoma | 2020-12-22 | “today announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib” amgen.com ↗ |
| Filed | US (FDA) | — | non-small cell lung carcinoma | 2020-12-16 | “today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib” amgen.com ↗ “Amgen submitted the sotorasib NDA on Dec. 16, 2020” amgen.com ↗ |
| Filed | UK (MHRA) | — | non-small cell lung carcinoma | — | “through the initiative, has submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia , Brazil , Canada and the United Kingdom” amgen.com ↗ “Additionally, Amgen submitted MAAs for sotorasib in Australia , Brazil , Canada and the United Kingdom in January 2021” amgen.com ↗ “Additionally, Amgen submitted MAAs for sotorasib in Australia , Brazil , Canada and the United Kingdom in Jan. 2021” amgen.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansion | US (FDA) | LUMAKRAS | — | 2025-01-16 | fda.gov ↗ |
| Filed | Other | — | — | 2022-09-11 | “Additionally, Amgen has submitted MAAs in Argentina , Colombia , Hong Kong , Kuwait , Malaysia , Mexico , Qatar , Saudi Arabia , Taiwan , Thailand and Turkey .” amgen.com ↗ |
| Filed | Other | — | — | 2022-03-08 | “Additionally, Amgen has submitted MAAs in Argentina , Colombia , Hong Kong , Kuwait , Malaysia , Mexico , Qatar , Saudi Arabia , Taiwan , Thailand and Turkey .” amgen.com ↗ “Additionally, Amgen has submitted MAAs in Turkey , Taiwan , Colombia , Thailand , Mexico , Hong Kong , Saudi Arabia , Argentina , Kuwait and Qatar .” amgen.com ↗ |
| Approved · conditional | EU (EMA) | Lumykras | — | 2022-01-06 | europa.eu ↗ |
| Approved | US (FDA) | LUMAKRAS | — | 2021-05-28 | fda.gov ↗ |
Trials 62 · started per year
today
US approved 2021
EU approved 2022
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 128 trials · 1 met primary | ||||||
| Phase 1 | NCT06892054 | Aug 2025 → Aug 2030 expected | pancreatic adenocarcinoma | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | Recruiting | No outcome recorded |
| Phase 1 | NCT06804824 | Feb 2025 → Aug 2027 expected | cancer | Vividion Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06807619 | Jan 2025 → Jan 2028 expected | brain neoplasm | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06333951 | Sep 2024 → Oct 2026 expected | non-small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06061523 | Jul → Sep 2024 | — | Amgen | Withdrawn | No outcome recorded |
| Phase 1 | NCT06249282 | Apr 2024 → Nov 2026 expected | non-small cell lung carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06127940 | Oct 2023 → Jun 2025 | non-small cell lung carcinoma | Karolinska University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05815173 | Aug 2023 → Aug 2027 expected | respiratory system cancer | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 1 | NCT05374538 | Nov 2022 → Aug 2023 | non-small cell lung carcinoma | Vitrac Therapeutics, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05497557 | Jul → Sep 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05480865 | Jul 2022 → Aug 2024 | metastatic malignant neoplasm, non-small cell lung carcinoma | Navire Pharma Inc., a BridgeBio company | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05327491 | Mar → Jul 2022 | — | Amgen | Completed | Met primary |
| Phase 1 | NCT04959981 | Sep 2021 → Apr 2023 | non-small cell lung carcinoma | Erasca, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05045638 | Aug → Oct 2021 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05048784 | Aug 2021 → Feb 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04892017 | Jun 2021 → Mar 2026 | metastatic neoplasm, non-small cell lung carcinoma | Deciphera Pharmaceuticals, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04887064 | Apr 2021 → Mar 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05599828 | Jul → Sep 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04380753 | Apr 2020 → Dec 2021 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05578859 | Mar 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05571163 | Mar → Jun 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05581992 | Jan 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04185883 | Dec 2019 → Dec 2026 expected | cancer | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05568082 | Dec 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05581758 | Nov 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05550129 | Nov 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05577624 | Nov → Dec 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05598281 | Nov 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07012031 | Jun 2026 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05251038 | Sep 2022 → Jan 2023 | malignant pancreatic neoplasm | Devalingam Mahalingam | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05180422 | Jun 2022 → Jan 2023 | non-small cell lung carcinoma | Criterium, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05074810 | Apr 2022 → Jun 2026 overdue | non-small cell lung carcinoma | Verastem, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05313009 | Mar 2022 → Jul 2023 | non-small cell lung carcinoma | Medical University of South Carolina | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04720976 | Mar 2021 → Dec 2023 | non-small cell lung carcinoma | Allist Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04092673 | Oct 2019 → Dec 2024 | cancer | Effector Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT03600883 | Aug 2018 → May 2026 | — | Amgen | Completed | No outcome recorded |
| Phase 220 trials | ||||||
| Phase 2 | NCT07543172 | Oct 2026 → Jun 2029 expected | non-small cell lung carcinoma | Roswell Park Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07172919 | Jan 2026 → Jan 2028 expected | — | Amgen | Recruiting | No outcome recorded |
| Phase 2 | NCT07124884 | Aug 2025 → Jun 2030 expected | acute myeloid leukemia, KRAS gene mutation, colorectal carcinoma | Federation Francophone de Cancerologie Digestive | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06068153 | Mar 2025 → Sep 2026 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Withdrawn | No outcome recorded |
| Phase 2 | NCT06582771 | Aug 2024 → Aug 2027 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05638295 | Aug 2024 → Dec 2028 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05815186 | Apr 2024 → Apr 2025 | respiratory system cancer | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 2 | NCT06333678 | Mar 2024 → Jan 2026 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05993455 | Jul → Sep 2023 | — | Korea University Anam Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2027 expected | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05564377 | Apr 2023 → Jul 2030 expected | Her2-receptor negative breast cancer, endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05631249 | Dec 2022 → Dec 2027 expected | acute myeloid leukemia, KRAS gene mutation, non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT05451056 | Aug 2022 → Jan 2026 | non-small cell lung carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT05400577 | Jul 2022 → Jan 2024 | non-small cell lung carcinoma | Fox Chase Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05311709 | May 2022 → Oct 2024 | non-small cell lung carcinoma | Vestre Viken Hospital Trust | Unknown | No outcome recorded |
| Phase 2 | NCT05118854 | Mar 2022 → Oct 2027 expected | lung cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05398094 | Mar 2022 → Dec 2027 expected | non-small cell lung carcinoma | Fundación GECP | Recruiting | No outcome recorded |
| Phase 2 | NCT04933695 | Jan 2022 → May 2025 | non-small cell lung carcinoma | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT05054725 | Dec 2021 → Jul 2024 | non-small cell lung carcinoma | Revolution Medicines, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04625647 | Apr 2021 → Dec 2026 expected | lung adenocarcinoma | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT06252649 | Jul 2024 → Sep 2028 expected | colorectal cancer | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT05920356 | Nov 2023 → Jun 2027 expected | non-small cell lung carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT05198934 | Apr 2022 → Jul 2025 | colorectal cancer | Amgen | Completed | Met primary |
| Phase 3 | NCT04303780 | Jun 2020 → Aug 2022 overdue | — | Amgen | Active not recruiting | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06314763 | Nov 2023 → Mar 2024 | — | Radboud University Medical Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04667234 | — | non-small cell lung carcinoma | Amgen | No longer available | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05036291 Background | Oct 2021 → Sep 2025 | cancer or benign tumor | Ningbo Newbay Technology Development Co., Ltd | Terminated | No outcome recorded |
| Phase 1/2 | NCT07563738 Background | Mar 2026 → Sep 2029 expected | malignant pancreatic neoplasm, mesothelioma, non-small cell lung carcinoma | Orion Corporation, Orion Pharma | Recruiting | No outcome recorded |
| Phase 3 | NCT06497556 Comparator | Sep 2024 → May 2026 overdue | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2026-07-01 | Genentech, Inc. | Results Genentech’s Divarasib Shows Superiority in Head-To-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today positive results from the Phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against the approved, first generation KRAS G12C inhibitors sotorasib or adagrasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC). |
| 2026-07-01 | Genentech, Inc. | Results Genentech’s Divarasib Shows Superiority in Head-to-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer gene.com ↗
The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS). |
| 2025-12-29 | Verastem, Inc. | Results Verastem Oncology Provides Update on RAMP 203 Phase 1/2 Clinical Trial for Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer verastem.com ↗
While avutometinib plus defactinib combined well with a G12C inhibitor to drive early and sustained anti-tumor responses, next generation G12C inhibitors are establishing a new benchmark with higher response rates. |
| 2025-01-17 | Amgen | Regulatory FDA APPROVES LUMAKRAS® (SOTORASIB) IN COMBINATION WITH VECTIBIX® (PANITUMUMAB) FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER amgen.com ↗ |
| 2024-12-18 | Verastem, Inc. | Results Verastem Oncology Provides a Clinical Update for RAMP 203 Trial in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer verastem.com ↗
No dose-limiting toxicities (DLTs) have been observed in the triplet combination. |
| 2024-01-18 | Verastem, Inc. | Regulatory Verastem Oncology Granted Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC) verastem.com ↗ |
| 2023-12-26 | Amgen | Regulatory AMGEN PROVIDES REGULATORY UPDATE ON STATUS OF LUMAKRAS® (SOTORASIB) amgen.com ↗
This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). |
| 2023-10-22 | Amgen | Results AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS VECTIBIX® (PANITUMUMAB) DATA IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER amgen.com ↗
Both doses demonstrated a statistically significant superiority in progression-free survival (PFS) over the investigator's choice of therapy in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). |
| 2023-10-16 | Amgen | Results AMGEN TO PRESENT NEW RESEARCH FROM ONCOLOGY PORTFOLIO AND PIPELINE AT ESMO 2023 amgen.com ↗
Pivotal Phase 3 CodeBreaK 300 Study Data Support LUMAKRAS ® (sotorasib) Plus Vectibix ® (panitumumab) Combination in KRAS G12C-Mutated mCRC |
| 2023-10-14 | Verastem, Inc. | Results Verastem Oncology Announces Initial Results of RAMP 203 Trial of Avutometinib and LUMAKRAS™ (sotorasib) in KRAS G12C-Mutant Non-Small Cell Lung Cancer verastem.com ↗
These initial findings, including the recommended Phase 2 dose and the encouraging preliminary efficacy and safety results, provide support for the combination, and I look forward to completing the expansion phase of the trial. |
| 2023-09-10 | Amgen | Results AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS CHEMOTHERAPY DATA IN FIRST-LINE KRAS G12C NSCLC AT WCLC amgen.com ↗
In patients treated in the first-line setting (n=20), the confirmed objective response rate (ORR) was 65%, with a 100% disease control rate (DCR) (95% CI: 83.2, 100). |
| 2023-08-21 | Amgen | Regulatory AMGEN TO DISCUSS APPLICATION FOR LUMAKRAS® (SOTORASIB) FOR THE TREATMENT OF KRAS G12C-POSITIVE NSCLC AT FDA ADVISORY COMMITTEE MEETING amgen.com ↗ |
| 2023-08-03 | Amgen | Results AMGEN REPORTS SECOND QUARTER FINANCIAL RESULTS amgen.com ↗
Positive Top-Line Results for LUMAKRAS ® (Sotorasib) Plus Vectibix ® (Panitumumab) in Metastatic Colorectal Cancer |
| 2023-06-04 | Amgen | Results AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) CODEBREAK 200 CNS DATA AT ASCO 2023 amgen.com ↗
LUMAKRAS ® (sotorasib) Demonstrated Delayed Time to CNS Progression, Longer CNS PFS and Higher Intracranial ORR vs Docetaxel in Post-Hoc Analysis of Phase 3 CodeBreaK 200 Trial |
| 2023-06-01 | Amgen | Results AMGEN PRESENTS NEW SCIENTIFIC AND CLINICAL RESEARCH ACROSS ITS DIVERSE ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2023 amgen.com ↗
Novel Combinations Show Encouraging Safety and Efficacy in Pre-Treated KRAS G12C-Mutated Metastatic CRC and First-Line NSCLC |
| 2022-09-12 | Amgen | Results LUMAKRAS® (SOTORASIB) COMBINED WITH VECTIBIX® (PANITUMUMAB) SHOWS CONFIRMED 30% OBJECTIVE RESPONSE RATE IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER amgen.com ↗
We are thrilled to see these CodeBreaK 101 results, which show that LUMAKRAS plus Vectibix achieved a 30% confirmed objective response rate in patients with KRAS G12C-mutated metastatic colorectal cancer. |
| 2022-09-11 | Amgen | Results LUMAKRAS®/LUMYKRAS® (SOTORASIB) DEMONSTRATES SUPERIOR PROGRESSION-FREE SURVIVAL OVER DOCETAXEL IN FIRST POSITIVE PHASE 3 TRIAL OF A KRAS G12C INHIBITOR IN NON-SMALL CELL LUNG CANCER amgen.com ↗
Amgen (NASDAQ: AMGN) today announced detailed results from the global Phase 3 CodeBreaK 200 trial, which showed once-daily oral LUMAKRAS ® /LUMYKRAS ® (sotorasib) led to significantly superior progression-free survival (PFS; primary endpoint) and a significantly higher objective response rate (ORR; a key secondary endpoint) in patients with KRAS G12C-mutated non small cell lung cancer (NSCLC), compared with intravenous chemotherapy, docetaxel. |
| 2022-08-30 | Amgen | Results AMGEN ANNOUNCES TOPLINE DATA FROM LUMAKRAS® (SOTORASIB) PHASE 3 TRIAL IN NON-SMALL CELL LUNG CANCER amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS ® (sotorasib) met its primary endpoint of progression-free survival (PFS), demonstrating statistical significance and superiority over standard of care chemotherapy, intravenous docetaxel. |
| 2022-08-07 | Amgen | Results AMGEN DATA AT WCLC 2022 HIGHLIGHTS POTENTIAL TO DELIVER TRANSFORMATIVE MEDICINES FOR HISTORICALLY DIFFICULT-TO-TREAT LUNG CANCERS amgen.com ↗
First Data From LUMAKRAS Plus Immunotherapy and LUMAKRAS Plus SHP2 Inhibitor Combinations Show Clinical Activity and Support Ongoing Investigation |
| 2022-05-26 | Amgen | Results NEW DATA SHOWCASES HOW AMGEN IS ADVANCING ALL ANGLES OF CANCER CARE THROUGH INNOVATIVE ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2022 amgen.com ↗
At least one newly acquired genomic alteration at progression was detected in 19 (28%) NSCLC patients and in 33 (73%) CRC patients. |
| 2022-04-12 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Preclinical Data from DCC-3116 Program at the AACR Annual Meeting deciphera.com ↗
Results from the preclinical studies showed that KRASG12C inhibitors, sotorasib and adagrasib, activate ULK-mediated autophagy as an adaptive treatment resistance mechanism. |
| 2022-04-10 | Amgen | Results LUMAKRAS® (SOTORASIB) CODEBREAK 100 STUDY SHOWS TWO-YEAR OVERALL SURVIVAL OF 32.5% IN PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER amgen.com ↗
In this long-term, two-year analysis of 174 heavily pre-treated patients (172 with baseline measurable lesion(s)), LUMAKRAS demonstrated a centrally confirmed objective response rate (ORR) of 40.7%, disease control rate (DCR) of 83.7% and median duration of response (DOR) of 12.3 months. |
| 2022-02-14 | Amgen | Results LUMAKRAS® (SOTORASIB) SHOWS ENCOURAGING AND CLINICALLY MEANINGFUL ANTICANCER ACTIVITY IN PATIENTS WITH KRAS G12C-MUTATED ADVANCED PANCREATIC CANCER IN CODEBREAK 100 TRIAL amgen.com ↗
Data show encouraging and clinically meaningful anticancer activity and a positive benefit:risk profile. |
| 2022-01-20 | Amgen | Regulatory LUMAKRAS® (SOTORASIB) RECEIVES APPROVAL IN JAPAN FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that LUMAKRAS ® (sotorasib) has been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy. |
| 2022-01-10 | Amgen | Regulatory EUROPEAN COMMISSION APPROVES LUMYKRAS® (SOTORASIB) FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER amgen.com ↗ |
| 2021-11-12 | Amgen | Regulatory LUMYKRAS® (sotorasib) Receives Positive Opinion From EMA CHMP For Patients With KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer amgen.com ↗
The EMA CHMP positive opinion brings patients in the EU closer to this transformative therapy and highlights our commitment to improving patient outcomes in difficult-to-treat cancers. |
| 2021-09-16 | Amgen | Results LUMAKRAS™ (Sotorasib) Combined With Vectibix® (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer amgen.com ↗
These new data show that combining LUMAKRAS™ (sotorasib) with Vectibix ® (panitumumab), Amgen 's monoclonal antibody epidermal growth factor receptor (EGFR) inhibitor, demonstrated encouraging efficacy and safety. |
| 2021-09-08 | Amgen | Results Amgen Presents New Data From Thoracic Oncology Portfolio At WCLC21 amgen.com ↗
These new analyses, respectively, provide encouraging evidence of durable systemic anticancer activity in patients with previously treated, stable brain metastases with LUMAKRAS, as well as insights into biomarkers of LUMAKRAS response. |
| 2021-06-04 | Amgen | Results Results From Phase 2 CodeBreaK 100 Show LUMAKRAS™ (sotorasib) Is The First And Only KRAS G12C Inhibitor With Overall Survival Data amgen.com ↗
LUMAKRAS shows a median overall survival (OS) of 12.5 months among 124 evaluable patients, the majority of which were previously treated with both platinum-based chemotherapy and immunotherapy (81%) (data cutoff of March 15, 2021 ). |
| 2021-05-28 | Amgen | Regulatory FDA Approves LUMAKRAS™ (Sotorasib), The First And Only Targeted Treatment For Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer amgen.com ↗
LUMAKRAS has received accelerated approval based on overall response rate (ORR) and duration of response (DoR). |
| 2021-04-28 | Amgen | Regulatory Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study amgen.com ↗
Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose. |
| 2021-02-16 | Amgen | Regulatory FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. |
| 2021-01-29 | Amgen | Regulatory Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that its investigational KRAS G12C inhibitor sotorasib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). |
| 2021-01-28 | Amgen | Results Amgen's Investigational KRAS G12C Inhibitor Sotorasib Demonstrated Rapid, Deep And Durable Responses In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer amgen.com ↗
Sotorasib demonstrated a confirmed objective response rate (ORR) and disease control rate (DCR) of 37.1% and 80.6%, respectively, and a median duration of response of 10 months (data cutoff of Dec.1, 2020; median follow-up time was 12.2 months). |
| 2020-12-22 | Amgen | Regulatory Amgen Submits Sotorasib Marketing Authorization Application To The European Medicines Agency amgen.com ↗
Amgen (NASDAQ: AMGN) today announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRAS G12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). |
| 2020-12-16 | Amgen | Regulatory Amgen Submits Sotorasib New Drug Application To U.S. FDA For Advanced Or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation amgen.com ↗ |
| 2020-12-08 | Amgen | Regulatory Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRAS G12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy. |
| 2020-10-05 | Amgen | Results Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer amgen.com ↗
Sotorasib demonstrated an objective response rate (primary end point) consistent with previously reported Phase 1 data in patients with advanced NSCLC taking the 960 mg daily dose. |
| 2020-09-20 | Amgen | Results Clinical Data From Full Phase 1 Cohort Of Investigational Sotorasib Published In New England Journal Of Medicine amgen.com ↗
Median progression-free survival (mPFS) in patients treated with sotorasib was 6.3 months. |
| 2020-05-29 | Amgen | Results Amgen Presents New AMG 510 Clinical Data Across Multiple Solid Tumors During ASCO20 Virtual Scientific Program amgen.com ↗
Amgen (NASDAQ:AMGN) today announced new data from the CodeBreaK 100 clinical development program evaluating investigational AMG 510 (proposed INN sotorasib) in heavily pretreated patients with a range of KRAS G12C -mutant solid tumors. |
| 2019-10-30 | Amgen | Results The Discovery Of Amgen's Novel Investigational KRAS(G12C) Inhibitor AMG 510 Published In Nature amgen.com ↗
Early evidence of clinical activity of AMG 510 is also presented in the paper. |
| 2019-09-28 | Amgen | Results Amgen Announces New Clinical Data Evaluating Novel Investigational KRAS(G12C) Inhibitor In Patients With Solid Tumors At ESMO 2019 amgen.com ↗ |
| 2019-09-17 | Amgen | Results Amgen Showcases New Data From Oncology Pipeline And Portfolio At ESMO 2019 amgen.com ↗
In addition to the responses seen in non-small cell lung cancer patients with KRAS G12C -mutant tumors, we will report the first responses in advanced colorectal and appendiceal cancers at the upcoming congress. |
| 2019-09-08 | Amgen | Results Amgen Announces New Clinical Data Evaluating Novel Investigational KRAS(G12C) Inhibitor In Larger Patient Group At WCLC 2019 amgen.com ↗
The additional follow-up in a larger group of patients with non-small cell lung cancer (NSCLC) continued to show anti-tumor activity with no dose-limiting toxicities. |
| 2019-06-03 | Amgen | Results Amgen Announces First Clinical Data Evaluating Novel Investigational KRASG12C Inhibitor AMG 510 At ASCO 2019 amgen.com ↗
In the trial, there were no dose-limiting toxicities at tested dose levels. |
All press releases naming this drug 52 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sotorasib | “To evaluate the efficacy of induction with sotorasib (AMG 510) in combination with cisplatin (or carboplatin) and pemetrexed in patients with surgically resectable KRAS...” NCT05118854 ↗53“Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).” NCT04303780 ↗ “Sotorasib will be administered with the recommended dosage per prescribing information approved by the FDA” NCT05036291 ↗ “Sotorasib is administered as an 8-week-introduction treatment” NCT06127940 ↗ |
| Known as | (S)-AMG-510 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | AMG510 | “To evaluate the efficacy of induction with sotorasib (AMG 510) in combination with cisplatin (or carboplatin) and pemetrexed in patients with surgically resectable KRAS...” NCT05118854 ↗16“AMG510 (Sotorasib) is small molecule that specifically and irreversibly inhibits the KRAS-G12C mutant protein.” NCT05398094 ↗ “Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation” NCT03600883 ↗ “AMG510/Sotorasib was the first KRAS G12C inhibitor to the enter the clinic.” NCT05313009 ↗ |
| Known as | CT-AMG510AMG-510AMG510 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | KRAS G12C INHIBITOR 9 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | KRAS MUTANT-TARGETING AMG 510 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | LUMAKRAS | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | LUMYKRAS | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | SOTORASIB (AMG510) RACEMATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Action | Inhibit | “a highly potent, selective, and well-tolerated KRASG12C inhibitor” PMID 31820981 ↗ Dec 2019 |
| Modality | Small molecule | “identification of a novel quinazolinone scaffold” PMID 31820981 ↗ Dec 2019 |
| Route | Oral | “following administration as an oral Tablet formulation” NCT03600883 ↗ |
| Target | KRAS | “a highly potent, selective, and well-tolerated KRASG12C inhibitor” PMID 31820981 ↗ Dec 2019 |