Merck KGaA Discontinues Xevinapant Program in Locally Advanced Head and Neck Cancer Due to Phase III Trial Failure

1. Trial Discontinuation: Merck KGaA has discontinued the Phase III TrilynX study evaluating xevinapant plus chemoradiotherapy in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) due to the trial being unlikely to meet its primary objective of prolonging event-free survival.
2. Independent Data Monitoring Committee: The decision to stop the trial was based on a pre-planned interim analysis performed by the study’s Independent Data Monitoring Committee.
3. Safety Data: Topline safety data from the trial were overall compatible with the chemo-radio sensitizing properties of xevinapant.
4. Additional Study Termination: Merck KGaA will also halt the Phase III X-Ray Vision study, which was evaluating xevinapant plus radiotherapy in patients who underwent resection of locally advanced head and neck cancer.
5. Company Response: Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck KGaA, expressed disappointment but reaffirmed the company’s commitment to developing transformative medicines for areas of high unmet need.
6. Background: Xevinapant is an investigational oral small-molecule inhibitor of apoptosis proteins, which was licensed by Merck KGaA from Debiopharm International SA in 2021.