DARMSTADT, Germany - Monday, 16. October 2023

Not intended for UK-, US- or Canada-based media

(BUSINESS WIRE) -- Merck, a leading science and technology company, today announced that 28 abstracts featuring the latest research on the company’s oncology portfolio addressing unmet needs across bladder, head and neck, lung, colorectal and other cancers, will be presented at the 2023 European Society of Medical Oncology (ESMO) Annual Meeting, October 20-24, Madrid, Spain.

Presentations at the meeting encompass new analyses for the standard-of-care medicines BAVENCIO® (avelumab), TEPMETKO® (tepotinib) and ERBITUX® (cetuximab). Additional presentations and activities at ESMO highlight the company’s efforts to improve the lives of people with cancer. Key presentations include:

BAVENCIO

Based on the results of the randomized Phase III JAVELIN Bladder 100 study, the first-line maintenance regimen of BAVENCIO plus best supportive care has become a guideline-recommended standard of care in the locally advanced and metastatic urothelial carcinoma (UC) treatment setting. Previously presented long-term follow-up results have demonstrated median overall survival (OS) from start of chemotherapy of 29.7 months among patients receiving BAVENCIO who had not progressed on first-line platinum-based chemotherapy, establishing a new reference point for treatment outcomes in clinical studies. New analyses and real-world evidence to be presented at ESMO reinforce the role of the JAVELIN Bladder regimen in this setting.

Long-term efficacy and safety outcomes from JAVELIN Bladder 100 confirm the prolonged OS, progression-free survival, and tolerability of first-line maintenance with BAVENCIO in patients older than 65 years with advanced UC.

Further evidence from France and the United States, including first-time data in patients with advanced UC with histological variants in the French AVENANCE study, support the findings of JAVELIN Bladder 100 in real-world settings.

Additional real-world analyses reinforce the use of BAVENCIO as a treatment for advanced/metastatic Merkel cell carcinoma (MCC), a rare form of skin cancer. After a median follow-up of ~29 months, data from the MCC TRIM study showed a median OS of 52 months for patients with metastatic MCC treated with BAVENCIO in a real-world setting in Germany. Most patients (~86%) received first-line BAVENCIO. BAVENCIO was the first cancer immunotherapy to receive accelerated approval from the US Food and Drug Administration (FDA) in March 2017 for the treatment of metastatic MCC; the approval was based on the results of the multicenter, international, single-arm, open-label, Phase II JAVELIN Merkel 200 trial. In September 2023, the accelerated approval in the US was converted into full approval for use of BAVENCIO for the treatment of metastatic MCC.

TEPMETKO

TEPMETKO is the first oral MET inhibitor to have received a regulatory approval anywhere in the world for the treatment of advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations, with its approval in Japan in March 2020. Updated findings from the Phase II VISION trial, which is the largest study of a MET inhibitor in this setting and served as the basis for regulatory approvals, continue to show clinically meaningful long-term efficacy in patients with METex14-skipping NSCLC treated with TEPMETKO regardless of line of therapy (2L, 2L+ and 3L+).

Head and Neck Cancer

Aligned with the company’s commitment to addressing the unmet needs of patients with squamous cell carcinoma of the head and neck (SCCHN), a new analysis of real-world survival outcomes and survival risk factors in elderly patients with locally advanced (LA) disease will be presented. Findings highlight poor survival outcomes, especially in patients aged 70 years and older with advanced disease stage and comorbidities, underscoring the need for innovative effective treatments for this population.

The company is investigating the IAP (inhibitor of apoptosis protein) inhibitor xevinapant (formerly known as Debio 1143) in two ongoing Phase III clinical trials in patients with LA SCCHN. The first is the international, randomized, double-blind, placebo-controlled TrilynX study (NCT04459715) to evaluate the efficacy and safety of xevinapant versus placebo when added to definitive chemoradiotherapy in patients with unresected LA SCCHN. The second is XRay Vision (NCT05386550), an international randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of xevinapant versus placebo when added to adjuvant, post-operative radiotherapy in patients with resected LA SCCHN who are at high risk for relapse and are ineligible for cisplatin.

Additional company-sponsored activity at ESMO:

Medical Symposia

Putting Patients First: Cultivating Care in Bladder Cancer. Chair: Joaquim Bellmunt, USA. Saturday, 21 October 2023, 13:00-14:30, Toledo Auditorium

Exploring SCCHN: Insight Into an Evolving Treatment Landscape. Chair: Hisham Mehanna, UK. Saturday, 21 October 2023, 18:30-20:00, Oviedo Auditorium

Evening Lecture

Beyond biomarkers: Navigating patient selection in mCRC. Sunday, 22 October 2023, 19:45-22:00, Espacio La Salle, C. de San Juan de la Salle, 4

Additionally, the company will feature its 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 can be found at www.TheWallinSCCHN.com or at Booth #526.

Select Merck-related abstracts accepted for presentation at ESMO 2023 include (all times in CEST):

Advancing the Future of Cancer Care

At Merck, we strive every day to improve the futures of people living with cancer. Our research explores the full potential of promising mechanisms in cancer research, focused on synergistic approaches designed to hit cancer at its core. We are determined to maximize the impact of our standard-of-care treatments and to continue pioneering novel medicines. Our vision is to create a world where more cancer patients will become cancer survivors. Learn more at www.merckgrouponcology.com.

About BAVENCIO® (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.

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