Amgen To Showcase Data From Oncology Pipeline During ESMO Virtual Congress 2020
Amgen (NASDAQ:AMGN) announced it will present data from its oncology pipeline during the ESMO Virtual Congress 2020, taking place from Sept. 19-21, 2020. Key presentations include Phase 1 clinical results for AMG 510, a KRASG12C inhibitor for non-small cell lung cancer, and AMG 160, a bispecific T cell engager targeting prostate cancer. Highlights include a presentation on clinical benefit durability for AMG 510 on Sept. 20 and AMG 160 on Sept. 21. The company will also hold webcast calls on Sept. 20 and 21 to discuss Phase 1 data with investors.
- Presentation of Phase 1 results for AMG 510 poised to advance to Phase 3 study.
- Encouraging preliminary data from AMG 160 targeting difficult-to-treat prostate cancer.
- Active enrollment in multiple ongoing clinical trials enhancing pipeline visibility.
- None.
THOUSAND OAKS, Calif., Sept. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020.
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, 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 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 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 http://www.codebreaktrials.com.
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.
For more information, follow us on www.twitter.com/amgenoncology.
About Amgen
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.
Forward-Looking Statements
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, 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.
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.
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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631 (media)
Jessica Akopyan, 805-447-0974 (media)
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