THOUSAND OAKS, Calif., May 13, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from its oncology pipeline and marketed portfolio will be presented during the ASCO20 Virtual Scientific Program taking place May 29 - 31, 2020.
Notable data from the oncology pipeline include updated first-in-human studies evaluating sotorasib (AMG 510), a first-in-class investigational KRASG12C inhibitor, in patients with advanced colorectal cancer (CRC) and other solid tumors. Updated results from a Phase 1 dose escalation study of AMG 330, a BiTE® (bispecific T cell engager) molecule, in acute myeloid leukemia will be featured in an oral presentation.
"The development of Amgen's innovative medicines is rooted in our deep understanding of human and cancer genomes, which drives the advancement of next generation cancer treatments," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "At ASCO, the data we are sharing reinforce our commitment to advancing first-in-class therapies that can alter the course of cancer care for patients who need it most."
Amgen's abstracts are available on the ASCO website and include:
Clinical Data Abstracts (pipeline)
KYPROLIS® Clinical Data Abstract
IMLYGIC® Clinical Data Abstracts
Amgen Webcast Investor Meeting
Amgen will host a webcast call for the investment community in conjunction with the ASCO20 Virtual Scientific Program on Friday, May 29, at 1:00 p.m. PT. 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 participate to discuss Amgen's oncology program, including data being presented on the Company's 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.
To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com.
The subject of almost four decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRAS G12C is found in approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.3 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.
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 KYPROLIS® (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.4 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.4,5
Since its first approval in 2012, approximately 150,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:
KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi Arabia, Singapore, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.
Important U.S. KYPROLIS® (carfilzomib) Safety Information
Acute Renal Failure
Tumor Lysis Syndrome
Hepatic Toxicity and Hepatic Failure
Posterior Reversible Encephalopathy Syndrome (PRES)
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients
Please see full Prescribing Information at www.kyprolis.com.
About IMLYGIC® (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. The exact mechanism of action continues to be investigated.
IMLYGIC is the first and only oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory authorities, based on therapeutic benefit demonstrated in a pivotal Phase 3 study. IMLYGIC is indicated for the local treatment of melanoma in patients with unresectable cutaneous, subcutaneous, or nodal lesions after initial surgery.
The IMLYGIC clinical program continues to investigate the role of IMLYGIC both as monotherapy and in combination with other therapies across a variety of cancers and treatment settings.
INDICATION & LIMITATIONS OF USE
IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Please see www.Imlygic.com for full Prescribing Information, including Medication Guide.
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 about Amgen Biosimilars, 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.
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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)