Merck KGaA abandons head and neck cancer drug previously seen as key growth driver

Merck KGaA has recently announced the discontinuation of two pivotal Phase III clinical trials involving its inhibitor-of-apoptosis proteins (IAP) antagonist, xevinapant, aimed at treating head and neck squamous cell carcinoma (HNSCC). This decision marks the second late-stage trial failure for the German pharmaceutical company this year.

The primary reason behind this move was the outcome of the TrilynX study. This particular trial was designed to assess the efficacy of xevinapant combined with chemoradiotherapy in patients suffering from unresected, locally advanced HNSCC. Unfortunately, the study indicated that it was unlikely to achieve its primary goal of improving event-free survival rates among the participants. This failure led Merck to also terminate the X-Ray Vision trial, which was investigating the use of xevinapant in conjunction with radiotherapy for patients with resected HNSCC. The company cited the cumulative data as the reason for halting this trial as well.

The setback with xevinapant is especially disappointing for healthcare professionals and key opinion leaders (KOLs) who had high hopes for the TrilynX trial. Earlier in the year, many experts believed that the trial had the potential to significantly alter treatment practices for high-risk HNSCC patients. However, there were also more cautious voices within the medical community who pointed out a history of Phase III trial failures in this particular domain.

With the termination of both the TrilynX and X-Ray Vision studies, Merck currently has no ongoing clinical investigations involving xevinapant. This development might pose a significant challenge for the company's previously laid-out healthcare business projections, particularly their medium-term growth forecast in the mid-single-digit percentage range. This is further exacerbated by the earlier discontinuation of another anticipated growth driver, the multiple sclerosis treatment evobrutinib, which also failed in a Phase III trial in March.

Despite these setbacks, Merck has stated that it will conduct a comprehensive review of the data gathered from the xevinapant trials. The company plans to share the findings in a peer-reviewed medical journal, which could provide further insights into the drug's performance and potential future applications.

In summary, Merck KGaA has faced significant hurdles this year with the failure of key late-stage trials for both xevinapant and evobrutinib. These developments underscore the inherent challenges and uncertainties in the field of pharmaceutical research and development, particularly in the quest to find effective treatments for complex conditions such as HNSCC. The outcomes of the in-depth data reviews and subsequent peer-reviewed publications will be crucial in determining the future trajectory of Merck's research efforts and its strategic direction in oncology and other therapeutic areas.