Merck KGaA Discontinues Xevinapant Program for Locally Advanced Head and Neck Cancer

1. Discontinuation of Phase III Trial: Merck KGaA has discontinued the Phase III TrilynX study evaluating xevinapant plus chemoradiotherapy in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
2. Reason for Discontinuation: The decision was based on a pre-planned interim analysis that found the trial would be unlikely to meet its primary objective of prolonging event-free survival.
3. Safety Data: Top-line safety data were overall compatible with the chemo-radio sensitizing properties of xevinapant.
4. Impact on Other Trials: The company has also stopped the Phase III clinical trial X-Ray Vision, which was evaluating xevinapant plus radiotherapy in patients who underwent resection of locally advanced head and neck cancer.
5. Commitment to Oncology Portfolio: Despite the discontinuation, Merck KGaA remains committed to developing transformative medicines within its oncology portfolio for areas of high unmet need.
6. Erbitux: The company continues to support the head and neck cancer community with Erbitux, which is approved in Europe in combination with radiotherapy for the treatment of locally advanced SCCHN.
7. Market Impact: Merck KGaA's shares have plunged following the announcement of the trial's discontinuation.