The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab.

Drugs · 2024 · PMC11652590 · PMID 39538109

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did not reach statistical significanceno p-value reported

In the HCC case, the initial confirmatory trial, KEYNOTE-240 ( NCT02702401 ) did not reach statistical significance for either dual primary endpoint, OS or PFS [ 83 ].

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