Tempest Therapeutics Inc. (NASDAQ:TPST) stock is trading higher on Thursday, with a strong session volume of over 23 million as per data from Benzinga Pro.
The company entered into an agreement with Roche Holdings AG (OTC:RHHBY) 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 Phase 3 trial for the first-line treatment of liver cancer.
Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study.
This agreement builds on a clinical collaboration between the companies under 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.
"Based on the positive Phase 2 data, I believe this combination therapy holds the potential to 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 CEO of Tempest.
In June, Tempest reported updated survival data from the ongoing global randomized Phase 1b/2 study, demonstrating a six-month improvement in median overall survival (OS) for patients receiving the combination therapy compared to the control arm of atezolizumab and bevacizumab alone.
The survival benefit observed in the amezalpat arm was also maintained in key subpopulations.
These June data build upon previously released data from the primary analysis showing that the amezalpat combination therapy provided clinical benefit regardless of PD-L1 status and in patients with both immune excluded and immune desert tumors.
Patients with a mutation in the beta-catenin gene had an increased objective response rate, and a longer median OS was observed in the updated data set. Both were supported by amezalpat's purported mechanism of action.
The company is preparing for the Phase 3 study to start in the first quarter of 2025.
Price Action: TPST stock is up 23% at $1.66 during the premarket session at last check Thursday.
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