Tempest Therapeutics announced positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration for amezalpat in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma. Key outcomes of the FDA meeting include: Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints; Agreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 study; Agreement on the Phase 3 statistical plan including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months.
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