Roche Holding AG’s (OTC:RHHBY) Genentech sells bevacizumab as Avastin and atezolizumab as Tecentriq.
Also Read: What’s Going On With Cancer-Focused Tempest Therapeutics Stock On Thursday?
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 the appropriateness of the current amezalpat dose and the Phase 3 study schedule.
- 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.
The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting.
The company is preparing for the Phase 3 study start in the first quarter of 2025.
Price Action: TPST stock is up 34.90% at $1.61 at the last check on Thursday.
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