Tempest Therapeutics is moving forward with a Phase 3 trial for its liver cancer therapy, amezalpat, through a collaboration with Roche. The partnership, announced on October 10, will see Roche providing atezolizumab globally for Tempest's study in first-line Hepatocellular Carcinoma (1L HCC).
Collaboration Details
Under the agreement, Tempest Therapeutics will sponsor and direct the pivotal study, while Roche supplies the drug. This arrangement builds upon a prior clinical partnership where amezalpat was tested with Roche's standard of care (SoC) atezolizumab/bevacizumab in a Phase 1b/2 trial within Roche's MORPHEUS-Liver program.
Regulatory and Clinical Milestones
Tempest has concluded a successful End of Phase 2 (EOP2) meeting with the FDA, securing agreement on the Phase 3 study plan. The FDA has also concurred with the statistical plan, which includes an early efficacy analysis that could shorten the study's timeline to primary analysis by approximately eight months. The primary endpoint of the study will be overall survival (OS).
Financial Implications
While Tempest acknowledged the need for substantial funding to support the Phase 3 study, estimated at around $100 million, the Roche agreement is expected to yield significant cost savings. With at least 700 subjects anticipated for enrollment, the collaboration could reduce expenses by an estimated $30-50 million. Tempest aims to initiate the pivotal study in the first quarter of 2025. The company reported having $39.2 million in cash at the end of the second quarter of 2024.
Clinical Data
Recent data from an ongoing study revealed a six-month median overall survival improvement for patients treated with the combination therapy of amezalpat, atezolizumab, and bevacizumab.
Analyst Perspectives
H.C. Wainwright reaffirmed its Buy rating and $47.00 stock price target for Tempest Therapeutics following the Roche deal. Scotiabank has reiterated its Sector Outperform rating on shares of Tempest Therapeutics, reflecting confidence in the company's strategic position and the expected swift patient recruitment for its clinical program for hepatocellular carcinoma treatment.
