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DARMSTADT, Germany–BUSINESS WIRE–
Merck, a leading science and technology company, today announced the discontinuation of the Phase III randomized TrilynX study evaluating xevinapant plus chemoradiotherapy (CRT) in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). The decision follows a pre-planned interim analysis performed by the study’s Independent Data Monitoring Committee, which found that the trial would be unlikely to meet its primary objective of prolonging event-free survival. Top-line safety data were overall compatible with the chemo-radio sensitizing properties of xevinapant. The company will conduct an in-depth review of the data and will share the results in a peer-reviewed forum.
LA SCCHN has proven to be a difficult-to-treat form of cancer. CRT has remained the standard of care for decades, despite multiple studies designed to improve outcomes with new treatment approaches, including multiple immunotherapy trials.
“We sincerely thank the patients, caregivers and clinical investigators who participated in this trial,” said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck. “While we are disappointed by these results, we remain steadfast in our commitment to develop transformative medicines within our oncology portfolio for areas of high unmet need.”
Given the totality of the data, the company decided to also stop the Phase III clinical trial X-Ray Vision (xevinapant plus radiotherapy, compared to placebo plus radiotherapy) in patients who underwent resection of locally advanced head and neck cancer.
Merck is working to develop and deliver new treatment options that exploit the vulnerabilities of tumor cells. The company is exploring modalities including antibody-drug conjugates (ADCs) and DNA damage response (DDR) inhibitors, across multiple tumor types, including many that have proven difficult to treat where there are significant unmet needs for patients. The company’s support for the head and neck cancer community remains steadfast with Erbitux®, approved in combination with radiotherapy for the initial treatment of locally advanced SCCHN, and which continues to be studied in more than 200 active clinical trials, including at least 15 Phase III studies.
About Xevinapant
Xevinapant (formerly known as Debio 1143) is an investigational potent oral small-molecule IAP (inhibitor of apoptosis protein) inhibitor. In March 2021, Merck gained exclusive rights from Debiopharm International SA to develop and commercialize xevinapant worldwide. Xevinapant is not approved for any use anywhere in the world.
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