Tempest Enters Agreement with Roche to Progress Amezalpat Therapy in Hepatocellular Carcinoma

2 min read | October 10, 2024 05:33 AM PDT | By Team Kalkine Media

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Tempest Enters Agreement with Roche to Progress Amezalpat Therapy in Hepatocellular Carcinoma — Image source: Shutterstock

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Highlights:

Tempest Therapeutics has entered into an agreement with Roche to advance amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
The Phase 3 trial is scheduled to commence in Q1 2025, following promising Phase 2 data that indicated a six-month improvement in median overall survival with the combination therapy.
Tempest will sponsor and lead the pivotal study, while retaining all development and commercial rights to amezalpat, and the FDA has approved the study plan, including the primary endpoint and statistical analysis.

Tempest Therapeutics {NASDAQ:TPST} has announced a strategic agreement with Roche to progress amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab into a pivotal Phase 3 clinical trial aimed at treating unresectable or metastatic hepatocellular carcinoma (HCC). This trial is set to begin in the first quarter of 2025, building on the encouraging Phase 2 data that demonstrated a six-month increase in median overall survival for patients receiving the combination therapy compared to those in the control group.

As part of the agreement, Roche will provide atezolizumab for the trial on a global scale, while Tempest will take the lead in sponsoring and managing the pivotal study. Importantly, Tempest retains all development and commercial rights to amezalpat, allowing the company to maintain control over the future direction of the drug.

The Food and Drug Administration (FDA) has reviewed and approved the Phase 3 study plan, which includes the primary endpoint and statistical methodology. Additionally, a pre-specified early efficacy analysis has the potential to expedite the study's timeline, possibly shortening it by up to eight months. This development marks a significant step for Tempest Therapeutics as it seeks to deliver innovative treatment options for patients with HCC, a challenging and often aggressive form of liver cancer.

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