Xevinapant Five-Year Data Show Survival Rate Nearly Doubled in Patients with Unresected LA SCCHN, When Added to Standard of Care

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• First randomized trial in decades to show significant improvement in overall survival in patients with LA SCCHN, reinforcing the transformative potential of xevinapant over standard of care in the curative setting
• Patients treated with xevinapant plus CRT almost twice as likely to be alive at five years (53% vs 28%) in Phase II study
• Two ongoing Phase III clinical trials of xevinapant in this setting, TrilynX and XRay Vision, are currently recruiting, with more than 250 centers worldwide

Excerpt from the Press Release:

ROCKLAND, Mass.–(BUSINESS WIRE)–EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the US and Canada, today announced that the IAP (inhibitor of apoptosis protein) inhibitor xevinapant (formerly known as Debio 1143) plus chemoradiotherapy (CRT) markedly improved long-term efficacy outcomes in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) compared with placebo plus CRT. The addition of xevinapant more than halved the risk of death over five years compared with placebo. These late-breaking data from the 96-patient Phase II trial will be presented during the mini-oral session on head and neck cancer on September 10, 2022 at 10:55 AM CEST (Abstract #LBA33) at the European Society of Medical Oncology Congress 2022.

“There is a clear need for improved treatment options for patients with unresected locally advanced head and neck cancer. Chemoradiotherapy has served as the standard of care in this setting for the past several decades, yet half of patients treated with CRT see their cancer return, whether locally or as metastatic disease,” said Prof. Jean Bourhis, M.D., Ph.D., Department Head of Radio-Oncology at the University Hospital of Lausanne and lead investigator of the study. “The five-year results from this randomized Phase II study are the first to show improved efficacy outcomes over standard of care for these patients and suggest the potential for xevinapant to increase the proportion of patients who achieve cure following definitive therapy.”

In this analysis, overall survival (OS) was evaluated at five years after the last patient was randomized; median follow-up was 60.1 months (range, 7.1-70.5 months) in the xevinapant arm and 39.2 months (range, 4.8-71.2 months) in the placebo arm. The data show:

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