Disappointing Phase 3 Trial Results Cause Merck to Shelve Head and Neck Cancer Drug

An interim analysis of Merck’s TrilynX study, involving patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) treated with a combination of its drug xevinapant and chemotherapy, revealed that the trial will be unable to meet its objective of extending event-free survival. As a result, the German biopharma has decided to discontinue the treatment.

In a post-market announcement, the company revealed that the trial had reached the worst-case scenario and failed to achieve its primary objective, highlighting the difficulty of treating LA SCCHN.

Based on all data collected so far, the company has also decided to shut down its other trial, X-Ray Vision, the second phase 3 trial focused on patients who underwent resection of LA SCCHN and were treated with xevinapant plus radiotherapy.

Initially, when the company shared phase 2 results for the drug at the ESCO Congress in 2022, xevinapant was observed to improve overall survival in patients compared to the standard of care. It was awarded breakthrough status by the US FDA and became a key asset in Merck’s oncology portfolio.

The failure of the trial is a significant setback for head and neck cancer patients, as advancements in this area have been limited in recent years. It also hinders Merck’s target of launching a new product every year and a half.

Merck, however, emphasized its continued commitment to the head and neck cancer community with its EGFR inhibitor Erbitux. Marketed by Eli Lilly, Erbitux is commercialized by Merck outside of the U.S. and Canada. Additionally, the company recognizes the need to strengthen its pipeline, particularly through external partnerships. Accelerating drug development and market entry remains a priority, as highlighted in last year’s R&D update.

Danny Bar-Zohar, Merck’s chief medical officer, said, “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.”

Merck licensed xevinapant from Debiopharm in 2021 in a deal costing over $1 billion. At one point, the treatment was ahead of rival drugs such as Ascentage Pharma/Clover Bio’s APG-1387, Astex Pharma’s tolinapant, and IGM Bio/Medivir’s birinapant.

According to analysts, the failure of xevinapant is a clear negative for the company, as it was the strongest pipeline candidate available in the near future.

This setback follows closely on the heels of another late-stage disappointment with Merck’s multiple sclerosis therapy evobrutinib. After two failed phase 3 trials, the treatment was abandoned last December, representing another significant setback.

As a result of these recent announcements, Merck’s stock on the Frankfurt Stock Exchange fell by 8%, trading at 153.65 euros.

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