Merck KGaA Abandons Trials After Phase III Head and Neck Cancer Study Failure

Merck KGaA has announced that its drug candidate xevinapant did not meet the expected outcomes in the Phase III TrilynX study, which aimed to improve survival rates in patients with locally advanced head and neck cancer. The company shared that an Independent Data Monitoring Committee concluded that the study was unlikely to achieve its primary goal of enhancing event-free survival during a planned interim analysis. Despite this, the safety profile of xevinapant matched its known chemo-radio-sensitizing effects.

Due to these results, Merck KGaA has decided to halt the TrilynX study. This trial was focused on patients with locally advanced squamous cell carcinoma of the head and neck who had not yet undergone surgical resection. Additionally, Merck KGaA will discontinue another study named X-Ray Vision, which was testing the combination of xevinapant with radiotherapy in patients with the same type of cancer who had received surgery.

Danny Bar-Zohar, Chief Medical Officer of Merck KGaA's healthcare division, expressed the company's disappointment but emphasized their ongoing dedication to developing transformative oncology treatments for high-need areas. The company plans to conduct a thorough review of the TrilynX study results and will share their findings in a peer-reviewed publication.

Xevinapant is an orally available small-molecule inhibitor designed to block apoptosis proteins that aid cancer cell survival. Its mechanism is intended to induce the death of tumor cells. Initially developed by Debiopharm International, Merck KGaA acquired exclusive global rights to xevinapant for approximately $226 million in March 2021.

The failure of xevinapant in the Phase III study represents a setback for Merck KGaA’s oncology program. This comes in the wake of another disappointment in December 2023, when the company's BTK inhibitor evobrutinib did not meet its primary efficacy endpoint in late-stage studies for relapsing multiple sclerosis. The drug failed to significantly reduce the annualized relapse rate compared to Sanofi’s Aubagio (teriflunomide), leading Merck KGaA to terminate its development in multiple sclerosis in March 2023.

Adding to their oncology efforts, Merck KGaA had previously strengthened its portfolio in April 2024 through a $1.4 billion agreement with Caris Life Sciences. This collaboration aims to discover and develop first-in-class antibody-drug conjugates for cancer treatment.

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