US-based biotechnology company Aravive has reported that its Phase III AXLerate-OC trial of batiraxcept for the treatment of platinum-resistant ovarian cancer failed to meet its primary endpoint of progression-free survival (PFS).
The study assessed batiraxcept’s efficacy and safety in the pre-specified subset of ovarian cancer patients who were naïve to prior bevacizumab treatment.
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It enrolled a total of 366 patients, half of whom received the therapy before entering the trial, while randomisation was stratified for previous bevacizumab treatment.
A hierarchical approach was followed for the evaluation of PFS. This began by assessing bevacizumab-naïve patients (n=179), followed by the overall cohort of patients.
In the bevacizumab-naïve population, a median PFS of 5.4 months was demonstrated in the batiraxcept-paclitaxel arm, compared with 5.4 months in the paclitaxel arm.
The median PFS in the batiraxcept-paclitaxel arm was 5.1 months in the overall population, against 5.5 months in the paclitaxel arm.
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By GlobalDataNo statistical difference between the two arms in the overall population was observed.
Batiraxcept’s safety profile was as expected from earlier studies and no new safety signals were identified.
Aravive president and CEO Gail McIntyre said: “We are conducting additional analyses on the AXLerate-OC Phase III trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer.
“We want to thank the patients who participated in this trial, the clinical investigators, and the Aravive team for their hard work, as we continue to pursue our goal of finding innovative cancer treatments for patients in need.”
Aravive expects to receive around $18m of unaudited cash at the end of the second quarter of this year, which will be enough to fund its operations early into the fourth quarter.
