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Tempest Partners with Roche to Advance Amezalpat Combination Therapy For Metastatic Liver Cancer Treatment

Tempest Therapeutics collaborates with Roche to advance amezalpat in a Phase 3 trial for unresectable liver cancer.

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  • Oct 11, 2024

  • Mrudula Kulkarni

Tempest Partners with Roche to Advance Amezalpat Combination Therapy  For Metastatic Liver Cancer Treatment

Tempest Therapeutics, Inc., a clinical-stage biotechnology firm focused on developing first-in-class targeted and immune-mediated cancer therapies, has announced a collaboration with Roche to evaluate amezalpat (TPST-1120) along with atezolizumab (Tecentriq®) and bevacizumab. This combination will advance into a pivotal Phase 3 trial aimed at treating unresectable or metastatic hepatocellular carcinoma (HCC), a liver cancer type with unmet medical needs. 


Roche will provide atezolizumab globally as part of the agreement, while Tempest will lead and sponsor the pivotal study. This partnership builds on their previous clinical collaboration, where amezalpat was tested with atezolizumab and bevacizumab against the standard regimen in a randomised Phase 1b/2 trial. Tempest retains all rights related to Amezalpat's development and commercialisation. 

“We’re excited to announce this agreement that supports the advancement of amezalpat into a pivotal study and reinforces both Tempest and Roche’s shared commitment to delivering groundbreaking cancer treatments for patients. Based on the positive Phase 2 data, I believe this combination therapy can significantly improve first-line liver cancer treatment, and we look forward to amezalpat moving into this pivotal Phase 3 study,” said Stephen Brady, president and chief executive officer of Tempest.

In June, Tempest reported encouraging survival data from the ongoing Phase 1b/2 study, showing a six-month increase in median overall survival (OS) for patients receiving the combination therapy compared to those on the standard treatment. This survival benefit was consistent across crucial patient subgroups. The data also indicated that the amezalpat combination provided clinical advantages irrespective of PD-L1 status and in patients with immune excluded and immune desert tumours. In particular, patients with beta-catenin gene mutations had higher response rates and longer median OS, reinforcing amezalpat's potential mechanism of action.


In August, Tempest held an end-of-phase two meeting with the FDA, where they reached a consensus on the Phase 3 study design, including the dosing schedule for amezalpat and the primary endpoint of OS, reflecting positive results from the Phase 2 study. The FDA also approved the statistical plan, which includes a pre-specified early efficacy analysis that could potentially expedite the timeline for primary analysis by eight months.


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