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
Detailed results of this potentially registrational Phase 2 clinical study in patients with advanced NSCLC will be submitted to the IASLC 2020
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.1,2 Targeting the KRAS protein, the most commonly altered family member in solid tumors, has been one of the toughest challenges in cancer research.1 A specific mutation known as KRAS G12C, is a major driver of tumor growth, occurring broadly across solid tumor indications. In the
The CodeBreaK clinical development program for
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.
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 is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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.
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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CONTACT: Amgen, Thousand Oaks
1 Cox AD, et al. Nat Rev Drug Discov. 2014;13:828-851.
2 Fernandez-Medarde A, et al. Genes Cancer. 2011;2:344-358.
3 Biernacka A, et al. Cancer Genet. 2016;209:195-198.
5 Neumann J, et al. Pathol Res Pract. 2009;205:858-862.
6 Jones RP, et al. Br
7 Wiesweg M, et al. Oncogene. 2019;38:2953-2966.
8 Canon J, et al. Nature. 2019;575:217-223.
9 Zhou L, et al. Med Oncol. 2016;33:32.
10 Ryan MB, et al. Nat Rev
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