Not intended for UK-, US- or Canada-based media DARMSTADT, Germany -- (BUSINESS WIRE) -- Merck, a leading science and technology company, today announced that 43 abstracts covering several modalities and mechanisms will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6, Chicago, Ill., US. New data for the medicines BAVENCIO® (avelumab), ERBITUX® (cetuximab), and TEPMETKO® (tepotinib) and pipeline assets including the first-in-class investigational IAP (inhibitor of apoptosis protein) inhibitor xevinapant demonstrate the Company’s efforts to pioneer novel medicines intended to improve the lives of people living with cancer. “The research we will present at ASCO 2023 demonstrates that we are not only maximizing the impact of our standard-of-care treatments but also advancing development programs focused on synergistic approaches targeting key cancer pathways and mechanisms,” said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck. Key presentations include: · BAVENCIO (Abstracts: 4515, 4516) clinical data reinforce its role as a standard of care in first-line maintenance for advanced urothelial carcinoma (UC): Poster discussions, including long-term safety analyses and an analysis of quality-adjusted survival from the Phase III JAVELIN Bladder 100 study, confirm the acceptable long-term benefit-risk profile as well as the net benefit estimate of BAVENCIO first-line (1L) maintenance and further support its use as a standard of care for advanced UC. As part of the JAVELIN Bladder regimen, BAVENCIO first-line maintenance has demonstrated the longest survival benefit seen to date in a global, randomized Phase III trial in advanced UC. · Xevinapant (Abstracts: TPS6101, 6027) preclinical data supporting dosing rationale for this investigational IAP inhibitor as well as a trial-in-progress poster outlining design of the recently initiated Phase III XRay Vision® study in locally advanced squamous cell carcinoma of the head and neck (LA SCCHN): Preclinical data demonstrate the benefit of extended xevinapant treatment beyond the completion of xevinapant plus radiotherapy (RT) and support the rationale for administration of six cycles of xevinapant in the ongoing Phase III studies, while also indicating that restoring sensitivity to apoptosis may address some unmet treatment needs in LA SCCHN. The trial design of the ongoing randomized Phase III XRay Vision study also will be featured. This study is assessing xevinapant plus RT in patients with resected, high-risk LA SCCHN who are not eligible for cisplatin. · TEPMETKO (Abstracts: 9021, 9060, 9070, 9074) data continue to demonstrate durable efficacy for first-line treatment of METex14 advanced non-small cell lung cancer (NSCLC): Long-term outcomes from the VISION study, the largest study of a MET inhibitor in patients with METex14-skipping advanced NSCLC (N=313), demonstrate the robust and durable clinical activity of TEPMETKO, particularly in the first-line setting, detected by liquid and/or tissue biopsy: with median follow-up of 32.6 months, in 164 first-line patients, overall response rate was 57.3% (95% CI: 49.4, 65.0) and median duration of response was 46.4 months (13.8, not estimable). A manageable safety profile further supports its use in clinical practice. Additional presentations for TEPMETKO include analyses from the INSIGHT 2 study in EGFRm METamp NSCLC for patients treated with TEPMETKO plus osimertinib. · ERBITUX (Abstracts: 3507, 3544, 3603) data to be presented at the congress add to the growing body of evidence supporting the role of cetuximab-based therapies across the continuum of care in the treatment of RAS wild-type metastatic colorectal cancer and as a backbone of treatment in SCCHN. Additional company-sponsored activity at ASCO: · CME Live Symposium & Webcast, “After More Than a Decade: Can We Now Enhance Treatment of Patients With LA SCCHN?” with course director Kevin Harrington, PhD, FRCR, FRCP, The Institute of Cancer Research, The Royal Marsden Hospital, London, UK, on June 3, 7:00-8:00 PM CDT, Hilton Chicago (720 South Michigan Ave.), room Continental A. · A UC Biosphere™ Connect event, “First-Line Maintenance Therapy: Supporting Patient Care in aUC” on June 4, 6:30-8:00 PM CDT, Marriott Marquis Chicago (connected to McCormick Place, 2121 S. Prairie Ave.), Great Lakes Ballroom C, Level 2) In addition to the data being presented at ASCO 2023, Merck will launch a new educational initiative for oncology professionals on the unmet medical need in LA SCCHN, cancer’s resistance to apoptosis, and the role of apoptosis proteins. More information on the initiative can be found at www.TheWallinSCCHN.com. Select Merck-related abstracts accepted for presentation at ASCO 2023 include (all times in CDT):
Advancing the Future of Cancer Care
About BAVENCIO® (avelumab)
BAVENCIO Approved Indications In the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced RCC. Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. BAVENCIO is currently approved for at least one indication for patients in more than 50 countries.
BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC) The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.
About TEPMETKO® (tepotinib) TEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020. In February 2021, the US Food and Drug Administration granted accelerated approval to TEPMETKO, making it the first and only once-daily oral MET inhibitor approved for patients in the US with metastatic NSCLC with METex14-skipping alterations. In February 2022, the European Commission (EC) approved once-daily oral TEPMETKO as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. TEPMETKO is available in a number of countries. To meet an urgent clinical need, TEPMETKO is also available in a pilot zone of China in line with the government policy to drive early access for innovative medicines approved outside of China. Merck is also investigating the potential role of tepotinib in treating patients with NSCLC and acquired resistance due to MET amplification in the Phase II INSIGHT 2 study of tepotinib in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib. TEPMETKO Safety Profile from the EU Summary of Product Characteristics (SmPC) The special warnings and precautions for use for TEPMETKO monotherapy include Interstitial lung disease (ILD) or ILD-like adverse reactions including pneumonitis, increase of liver enzymes (ALT and AST), QTc prolongation, and embryo-fetal toxicity. The most common adverse reactions in ≥ 20% of exposed to tepotinib at the recommended dose in the target indication are oedema, mainly peripheral oedema, nausea, hypoalbuminemia, diarrhea and increase in creatinine. The most common serious adverse reactions in ≥ 1% of patients are peripheral oedema, generalized oedema and ILD.
About Xevinapant
About ERBITUX® (cetuximab) ERBITUX has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998. All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
About Merck Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. View source version on businesswire.com: https://www.businesswire.com/news/home/20230525005670/en/ CONTACT:
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