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Bavencio Phase 3 head and neck cancer trial terminated

Published on 16/03/20 at 12:24pm

Merck KGaA, its biopharma division EMD Serono, and Pfizer have announced their decision to terminate their ongoing Phase 3 trial of the checkpoint inhibitor Bavencio (avelumab) after it became apparent following an independent Data Monitoring Committee interim analysis that the drug was unlikely to achieve its primary endpoint.

The drug was being tested in combination with chemoradiotherapy (CRT) for the treatment of untreated locally advanced squamous cell carcinoma of the head and neck. During a review of the data generated from 697 previously untreated patients, it was determined that the combo was not on track to produce a statistically significant improvement in progression-free survival compared to CRT alone.

Despite this setback, the three firms were keen to point out the success of the drug in January in Phase 3 trials for urothelial carcinoma, which accounts for around 90% of bladder cancer cases, where it was shown to extend overall survival compared to best supportive care.

The trio confirmed that a full analysis of the study findings would be shared with the scientific community in due time.

Bavencio has already secured approval in advanced renal cell carcinoma (kidney cancer), urothelial carcinoma and Merckel cell carcinoma.

Matt Fellows

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