On September 16, 2020 Amgen (NASDAQ:AMGN) reported that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, Sept. 19-21, 2020 (Press release, Amgen, SEP 16, 2020, View Source [SID1234565259]).
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Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations. Data from the study of sotorasib, Amgen’s investigational KRASG12C inhibitor, will showcase Phase 1 clinical results on durability of clinical benefit in patients with non-small cell lung cancer (NSCLC). Additionally, data from Amgen’s bispecific T cell engager (BiTE) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). Abstracts will be released on Saturday, Sept. 19, and will be followed by oral presentations (sotorasib, Sunday Sept. 20 and AMG 160, Monday Sept. 21) that will highlight more recent data.
"During ESMO (Free ESMO Whitepaper), we will highlight our pioneering work in two key areas of oncology research – KRAS inhibition and BiTE therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Clinicians will be presenting updated data from the first and largest Phase 1 human clinical study of an investigational KRASG12C inhibitor, sotorasib — now the first KRASG12C inhibitor to advance to a Phase 3 study. In addition, early and encouraging data from our BiTE platform in the solid tumor setting will be presented. Our data at ESMO (Free ESMO Whitepaper) underscore our unique approach to harnessing the human biology of cancer to alter the course of cancer care for patients who need it most."
Learn more about Amgen’s development of innovative medicines for novel targets in difficult-to-treat solid tumors at AmgenOncology.com.
Key Clinical Abstracts and Presentation Times (Pipeline):
Durability of Clinical Benefit and Biomarkers in Patients (pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) Treated With AMG 510 (sotorasib)*
Presentation #1257O, Proffered Paper Session, Sunday, Sept. 20, 2020, from 2:25 p.m. – 2:37 p.m. CEST / 5:25 a.m. – 5:37 a.m. PDT
Results From a Phase 1 Study of AMG 160, a Half-Life Extended (HLE), PSMA-Targeted, Bispecific T Cell Engager (BiTE) Immune Therapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Presentation #609O, Proffered Paper Session, Monday, Sept. 21, 2020, from 2:25 p.m. – 2:37 p.m. CEST / 5:25 a.m. – 5:37 a.m. PDT
Amgen Webcast Investor Call
Amgen will host two webcast calls for the investment community in conjunction with the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT, 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 investigators, will discuss Phase 1 data being presented on the Company’s investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen’s clinical development team, will discuss the Phase 1 data being presented on the Company’s investigational half-life extended bispecific T-cell engager (BiTE) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA).
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.
To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com.
About CodeBreaK
The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C-mutant solid tumors 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 were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.
Amgen’s single-arm Phase 2 trials in both non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK 100) are now fully enrolled. The potentially registrational Phase 2 trial in NSCLC is on track for data readout later in 2020 and a Phase 3 trial comparing sotorasib with docetaxel in NSCLC has begun recruiting. The Phase 2 CRC trial is expected to have a data readout in early 2021.
Amgen is currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101). In addition, a randomized global Phase 3 confirmatory study in NSCLC (CodeBreaK 200) has been initiated. Additional information about CodeBreaK clinical trials can be found at View Source
About BiTE Technology
BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific 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-specific 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.