Biotechnology company Tempest Therapeutics, Inc. (TPST) announced Thursday an agreement with Roche Group (RHHBY.PK) to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, a form of liver cancer with high unmet need.
Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study. Tempest is preparing for the Phase 3 study start in the first quarter of 2025.
This agreement builds on a clinical collaboration between the companies pursuant to which amezalpat was combined with atezolizumab and bevacizumab in first-line HCC patients and compared to atezolizumab and bevacizumab alone in a randomized Phase 1b/2 study. Tempest retains all development and commercial rights to amezalpat.
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