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:
- Registrational Phase 2 Trial of Sotorasib in KRAS p.G12C Mutant NSCLC: First Disclosure of the CodeBreaK 100 Primary Analysis
Presentation #PS01.07, Presidential Symposium, Saturday, Jan. 30 from 7:50-8 a.m. SGT / Friday, Jan. 29 from 3:50-4 p.m. PST
- Clinical Characteristics and Outcomes in Advanced KRAS Mutant NSCLC – A Multi-Centre Collaboration in Asia (ATORG-005)
Presentation #MA04.06, Mini-oral Presentation, Friday, Jan. 29 from 5:15-5:20 p.m. SGT / Friday, Jan. 29 from 1:15-1:20 a.m. PST
- A Phase 1 Study of AMG 757, Half-Life Extended Bispecific T-Cell Engager (BiTE®) Immune Therapy Against DLL3, in SCLC
Presentation #OA11.03, Oral Presentation, Sunday, Jan. 31 from 3:30-3:40 p.m. SGT / Saturday, Jan. 30 from 11:30-11:40 p.m. PST
- AMG 757, a Half-Life Extended Bispecific T-Cell Engager (HLE BiTE® Immuno-Oncology Therapy) Targeting DLL3, for the Treatment of Small Cell Lung Cancer
Presentation #P15.01, e-Poster Presentation
Amgen Webcast Investor Call
Amgen will host a webcast call for the investment community in conjunction with WCLC 2020. On Friday, Jan. 29, 2021 at 5 p.m. PST, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical trial investigators, will discuss the registrational Phase 2 NSCLC data being presented on the Company's investigational KRASG12C inhibitor sotorasib.
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.
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.1 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning four continents. In just over two years, the sotorasib clinical program CodeBreaK has established the deepest clinical data set with nearly 700 patients studied across 13 tumor types.
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
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.
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
BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient's own T cells to any tumor-associated antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-associated antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.
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.
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.
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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CONTACT: Amgen, Thousand Oaks
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1. Kim D, et al. Cell. 2020;183 :850-859.
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