Merck 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 sensitising 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.
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 tumour cells. The company is exploring modalities including antibody-drug conjugates (ADCs) and DNA damage response (DDR) inhibitors, across multiple tumour 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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