Amgen (NASDAQ: AMGN) today announced positive topline Phase 2 results from the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 126 patients with KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC), who had failed a median of two prior lines of anti-cancer therapies (immunotherapy and/or chemotherapy).
| THOUSAND OAKS, Calif., Oct. 5, 2020 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive topline Phase 2 results from the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 126 patients with KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC), who had failed a median of two prior lines of anti-cancer therapies (immunotherapy and/or chemotherapy). 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. Other measures of efficacy, including duration of response, were promising and more than half of the responders were still on treatment and continuing to respond as of the data cutoff date. Safety and tolerability were similar to previously reported data in Phase 1 in patients with advanced NSCLC. “Targeting KRAS has been a 40-year quest that has left patients with limited options. These topline data underscore our belief in the potential for sotorasib to become the standard of care for non-small cell lung cancer patients with the KRAS G12C mutation who remain in need of new treatment options,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We now have more than 500 patients who have been enrolled across clinical studies, and we are rapidly moving forward with a broad-based development program, which includes monotherapy studies in non-small cell lung cancer, colorectal cancer and other solid tumors harboring the KRAS G12C mutation, as well as a suite of combination studies. We look forward to discussing the current results with the U.S. Food and Drug Administration (FDA) and other regulatory agencies, to determine the best path forward for sotorasib as a potential treatment for patients with NSCLC harboring the KRAS G12C mutation.” Detailed results of this potentially registrational Phase 2 clinical study in patients with advanced NSCLC will be submitted to the IASLC 2020 World Congress on Lung Cancer taking place January 2021. A global Phase 3 randomized active-controlled confirmatory study comparing sotorasib to docetaxel in KRAS G12C-mutant NSCLC patients (CodeBreaK 200) has begun recruiting. About KRAS About CodeBreaK CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The study enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline. Amgen’s single-arm Phase 2 trial in colorectal cancer (CRC) (also part of CodeBreaK 100) is fully enrolled and topline results are expected in 2021. A global Phase 3 randomized active-controlled confirmatory study comparing sotorasib to docetaxel in KRAS G12C-mutant NSCLC patients (CodeBreaK 200) has begun recruiting. Amgen is also enrolling several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101). About Amgen Oncology For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them. At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do. To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology. About Amgen
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Forward-Looking Statements No forward-looking statement can be guaranteed and actual results may differ materially from those we project. 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We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. CONTACT: Amgen, Thousand Oaks References 1 Cox AD, et al. Nat Rev Drug Discov. 2014;13:828-851.
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Company Codes: NASDAQ-NMS:AMGN |
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