Ovarian Cancer Drug Trial Misses Primary Endpoint
Batiraxcept (AVB-S6-500), recently underwent a phase 3 clinical trial called AXLerate-OC (NCT04729608) to assess its potential in treating platinum-resistant ovarian cancer. The trial, conducted by Aravive, Inc., aimed to evaluate if combining batiraxcept with paclitaxel could improve progression-free survival (PFS) compared to paclitaxel alone.
The AXLerate-OC trial enrolled 366 patients with recurrent ovarian, fallopian tube, or peritoneal cancer, all having high-grade serous adenocarcinoma histology. The participants had experienced resistance to platinum therapy and were between 18 and 80 years old with an ECOG performance status of 0 or 1. All patients received at least one but not more than four prior lines of treatment.
The primary endpoint of the study was to determine whether batiraxcept, in combination with paclitaxel, could extend progression-free survival compared to paclitaxel alone. Disappointingly, the trial did not meet this primary goal. In a subgroup of patients who had not been exposed to bevacizumab (Avastin), the median PFS was the same for both the batiraxcept combination and paclitaxel alone, at 5.4 months. In the overall population, which included patients previously treated with bevacizumab, the median PFS was 5.1 months with the batiraxcept combination and 5.5 months with paclitaxel alone.
In a separate development, batiraxcept was awarded fast track designation by the FDA for use as a potential therapeutic option in patients with advanced or metastatic clear cell renal cell carcinoma (RCC). This designation was supported by encouraging findings from the phase 1b AVB500-RCC-003 trial (NCT04300140). The trial results showed a 57% objective response rate and a median PFS of 11.4 months when batiraxcept was combined with cabozantinib (Cabometyx) in pretreated patients, including those who had previously progressed on immuno-oncology (IO)– and VEGF TKI–based therapies.
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