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Tempest and Roche Partner to Advance Amezalpat Combination Therapy into First-Line Hepatocellular Carcinoma Pivotal Trial

NextEdge Admin

10 Oct 2024

1 min 53 sec

Tempest Therapeutics, a clinical-stage biotech company focused on developing targeted and immune-mediated cancer therapies, announced an agreement with Roche to advance the combination of amezalpat (TPST-1120) with atezolizumab (Tecentriq®) and bevacizumab into a pivotal Phase 3 trial for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). Atezolizumab and bevacizumab are the current standard of care for this form of liver cancer, which has a high unmet need.

Under the agreement, Roche will supply atezolizumab globally, while Tempest will sponsor and lead the trial. This follows a successful Phase 1b/2 study where amezalpat combined with atezolizumab and bevacizumab showed a six-month improvement in median overall survival (OS) compared to the standard therapy. Tempest retains all rights to amezalpat.

“We're excited to advance amezalpat into a pivotal study, reinforcing our commitment with Roche to deliver groundbreaking cancer treatments,” said Stephen Brady, CEO of Tempest. Positive Phase 2 data showed the combination therapy’s potential to improve first-line HCC treatment, with enhanced survival benefits in key subpopulations. After meeting with the FDA, Tempest has aligned on the Phase 3 study plan, aiming to expedite the timeline with a pre-specified early efficacy analysis.