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Trial Design Issues, Failure To Follow Guidance Likely to Hurt Merck At Keytruda Advisory Panel

 
• By Sarah Karlin-Smith

Merck’s decisions to repeatedly ignore US FDA’s advice will be on display as the company tries to convince the agency’s Oncologic Drug’s Advisory Committee the immunotherapy is ready for accelerated approval for patients with high-risk early-stage triple-negative breast cancer based on interim study results.

Molecular model of Keytruda
FDA is asking an advisory panel whether Merck's Keytruda needs more data before a regulatory decision for triple-negative breast cancer can be made • Source: Shutterstock

The US FDA offered a multi-prong critique of Merck & Co., Inc.’s application for Keytruda (pembrolizumab) to treat patients with high-risk early-stage triple-negative breast cancer in the run up to the company’s 9 February advisory committee review, highlighting philosophical differences with the sponsor about the level of unmet need and the data tradeoffs that would allow.

Merck is seeking accelerated approval for the immunotherapy to be used in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery based on interim results of the KEYNOTE-522 trial, a randomized double-blind placebo-controlled trial comparing Keytruda to placebo in

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