Phase 3 trial of combination for advanced head, neck cancer halted due to lack of benefit
Click Here to Manage Email Alerts
A randomized phase 3 trial designed to evaluate xevinapant with chemoradiotherapy as treatment for certain patients with head and neck cancers has been discontinued due to likely lack of benefit, according to the agent’s manufacturer.
Chemoradiotherapy has been standard care for locally advanced squamous cell carcinoma of the head and neck for multiple decades. Trials of new treatment approaches, including immunotherapy approaches, have not been successful.
The TrilynX trial assessed whether the addition of xevinapant (Merck KGaA, Darmstadt, Germany) — a small-molecule inhibitor of apoptosis protein — to chemoradiotherapy would improve outcomes for patients with unresected locally advanced HNSCC.
A preplanned interim analysis performed by the study’s independent monitoring committee showed the combination likely would not improve EFS, the trial’s primary endpoint.
The company will continue to review the data and share findings in a peer-reviewed forum, according to a Merck KGaA press release.
“We sincerely thank the patients, caregivers and clinical investigators who participated in this trial,” Danny Bar-Zohar, MD, the company’s global head of research and development and chief medical officer for the health care business sector, said in the release. “[Although] 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.”
The company also stopped the phase 3 X-Ray Vision trial, designed to compare radiotherapy plus either xevinapant or placebo for patients who underwent resection of locally advanced head and neck cancer.
Read more about
Click Here to Manage Email Alerts