KGaA (Merck) has discontinued the Phase III TrilynX trial evaluating xevinapant in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). The company stated that its decision was informed by a pre-planned interim analysis performed by the Independent Data Monitoring Committee. It found that the study is “unlikely to meet its primary objective of prolonging event-free survival”.
The gold standard of business intelligence. Merck licenced xevinapant from Debiopharm International in in 2021. Xevinapant is an inhibitor of apoptosis protein (IAP) antagonist designed to restore cancer cell sensitivity to apoptosis.
Following the news of trial termination, Merck’s stock was down by over 10% in trading on the Frankfurt Stock Exchange. The randomised placebo-controlled Phase III TrilynX trial (NCT04459715) enrolled approximately 730 participants with LA SCCHN. The study evaluated xevinapant in combination with chemoradiation therapy versus placebo and chemoradiation.
The trial’s primary endpoint was event-free survival for up to five years. Merck was quick to add that the safety data for xevinapant was “overall compatible with the chemo-radio sensitizing properties of the therapy”. The company plans to conduct an in-depth review of the data and share these results in the future.
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