Amgen (NASDAQ:AMGN) today announced new data from its oncology pipeline in lung cancer will be presented during the 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer taking place virtually from Jan. 28-31, 2021.
| THOUSAND OAKS, Calif., Jan. 12, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from its oncology pipeline in lung cancer will be presented during the 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer taking place virtually from Jan. 28-31, 2021. Phase 2 data from the CodeBreaK 100 clinical study, evaluating investigational sotorasib (AMG 510) in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) will be presented as part of the WCLC Presidential Symposium from 3:50-4 p.m. PST on Friday, Jan. 29. Additionally, updated Phase 1 data from AMG 757, an investigational first-in-class BiTE® molecule that is uniquely designed to target delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC), will also be presented in an oral presentation. “We are incredibly excited to present the first complete Phase 2 non-small cell lung cancer data set for an investigational KRASG12C inhibitor, including novel biomarker analyses,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “This is an historic moment not only for us, but for the scientific community working on the 40-year quest to target KRAS, one of cancer research’s toughest challenges. Additionally, following recent regulatory submissions to the FDA and European Medicines Agency, we remain focused on rapidly bringing this potential foundational KRAS G12C therapy to patients with advanced non-small cell lung cancer harboring this mutation.” “KRAS G12C is one of the most common driver mutations in non-small cell lung cancer; each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated non-small cell lung cancer,” said Suresh S. Ramalingam, M.D., deputy director of Winship Cancer Institute at Emory University in Atlanta. “The sotorasib data that will be presented at WCLC represents an important step forward in addressing the high unmet need for patients with this mutation.” Abstracts not featured in the Presidential Symposium are available at https://wclc2020.iaslc.org/. Learn more about how Amgen Oncology is advancing its pioneering science with the relentless pursuit of innovative modalities and unique pathways for cancer patients and their families at AmgenOncology.com/medical. Clinical Abstracts and Presentation Times:
Amgen Webcast Investor Call Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event. About Sotorasib Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.1 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 Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST 1.1 at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021. A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC patients (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b sotorasib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment. For information, please visit www.codebreaktrials.com. About BiTE® Technology 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. 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. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. 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. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks References
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Company Codes: NASDAQ-NMS:AMGN |
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