Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer

Amgen 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.

David M. Reese, M.D., executive vice president of Research and Development at Amgen Said: 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, 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

The RAS gene family, which has been the subject of almost four decades of research, contains some of the most frequently mutated oncogenes in human cancers. Targeting the KRAS protein, the most commonly altered family member in solid tumors, has been one of the toughest challenges in cancer research. A specific mutation known as KRAS G12C, is a major driver of tumor growth, occurring broadly across solid tumor indications. In the U.S., about 13% of patients with non-small cell lung cancer harbor the KRAS G12C mutation. It is also found in approximately 3-5% of colorectal cancers and 1-2% of numerous other solid tumors, making this among the most broadly represented mutations across cancer patient subgroups. With the discovery of a unique surface groove in the KRASG12C protein, Amgen developed and advanced the first investigational KRASG12C inhibitor into the clinic and is exploring the potential of KRASG12C inhibition across multiple tumor types for patients who remain in dire need of treatment options. 

About CodeBreaK

The CodeBreaK clinical development program for Amgen's investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 500 patients across 13 tumor types since its inception.

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

Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.

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.


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