Aravive's Phase III trial evaluating batiraxcept in patients with platinum-resistant recurrent ovarian cancer has been terminated after failing to meet its primary endpoint. The randomized, double-blind study (NCT04729608) compared the efficacy and safety of batiraxcept plus paclitaxel against placebo plus paclitaxel.
The trial's primary endpoint was median progression-free survival (PFS). According to ClinicalTrials.gov, the termination was due to the trial showing no significant differences in median PFS between the batiraxcept and paclitaxel or paclitaxel alone arms. The company reported that there was no detriment to overall survival, and no new safety signals were identified.
Impact on Likelihood of Approval
The failure of the Phase III trial has significantly impacted the drug's prospects. GlobalData’s analysis indicates that batiraxcept's Likelihood of Approval (LoA) in ovarian cancer has dropped by 10 points to 1%. LoA is calculated using a combination of machine learning and a proprietary algorithm, considering factors such as therapy area, indication, and molecule type.
Batiraxcept Mechanism of Action
Batiraxcept functions by inhibiting growth arrest-specific protein 6 (GAS6). The activation of the AXL receptor occurs when it binds to a GAS6 ligand on tumor cells, which causes tumor cell proliferation. Batiraxcept is designed to block this binding and prevent tumor progression.
Trial Design
The Phase III trial enrolled patients with platinum-resistant recurrent ovarian cancer. The study aimed to assess whether adding batiraxcept to paclitaxel could improve outcomes compared to paclitaxel alone. The termination of the trial represents a setback in the development of new treatments for this challenging disease.
