There was no difference in the risk of disease progression or death outcomes noted between patients with ovarian cancer treated with batiraxcept and paclitaxel vs batiraxcept alone in the AXLerate-OC trial.
The phase 3 AXLerate-OC trial (NCT04300140) of batiraxcept combiend with paclitaxel has missed its primary end point of progression-free survival (PFS) in patients with platinum-resistant ovarian cancer naïve to prior treatment with bevacizumab (Avastin).1
The median PFS was 5.4 months among patients given batiraxcept plus paclitaxel as well as in patients treated with paclitaxel alone in the bevacizumab-naïve population (n = 179). In the overall population which included 366 patients, the median PFS was 5.1 months with batiraxcept plus paclitaxel vs 5.5 months with paclitaxel alone.
Regarding safety, batiraxcept was comparable in the AXLerate-OC trial with previous reports of the agent, and no new safety signals were identified.
“Although AXLerate-OC did not meet the primary end point, I look forward to working with Aravive to analyze the phase 3 data and determine the most appropriate path to bring batiraxcept to those patients who may benefit most,” said Katherine Fuh, MD, PhD, an associate professor in the University of California San Francisco Division of Gynecologic Oncology, in a press release.
Previously in November 2023, the FDA granted a fast track designation (FTD) to batiraxceptfor patients with clear cell renal cell carcinoma that progressed after receiving 1 or 2 previous lines of systemic therapy. Findings from the phase 1b portion of the phase 1/2AVB500-RCC-003 trial (NCT04300140) were the basis of the FTD as treatment with batiraxcept plus cabozantinib (Cabometyx) showed there to be no dose limiting toxicities. The combination also generated a median PFS of 11.4 months and an overall response rate (ORR) of 57% among patients.2
In the international, double-blind, randomized phase 3 AXLerate-OC/GOG-3059/ENGOT OV-66 trial, investigators evaluated the safety and efficacy of batiraxcept in 366 patients with platinum-resistant ovarian cancer.3
Patients were randomized to receive 15 mg/kg of batiraxcept or matched placebo plus paclitaxel across 165 treatment sites in the United States and Europe. Randomization was stratified for prior bevacizumab treatment and 50% of the patients in the study received bevacizumab prior to entry.
Enrollment was open to patients aged 18 years and older with histologically confirmed recurrent ovarian, fallopian tube, or peritoneal cancer and high-grade serous adenocarcinoma histology. Patients must have received 1-4 prior lines of therapy, had an ECOG performance status of 0 or 1, platinum-resistant disease, archived tumor tissue, and measurable disease based on RECIST v1.1 criteria. Normal gastrointestinal function and full recovery from treatment-related toxicities of grade 1 or less to enroll on the trial were also required.
The primary end point of the trial was PFS with the secondary end point of overall survival. Exploratory end points also evaluated were duration of response, ORR, treatment-emergent adverse effects, quality of life, clinical benefit rate, and pharmacokinetics.
Though investigators noted that none of the differences in PFS outcomes were statistically significant between treatment arms, the complete dataset will continue to be evaluated to determine the next steps of batiraxcept.
“We are conducting additional analyses on the AXLerate-OC phase 3 trial to further evaluate the results of this study and determine the best path forward with our 2 other planned indications in renal cell carcinoma and pancreatic cancer,” said Gail McIntyre, PhD, DABT, president and chief executive officer of Aravive, Inc, in a press release.1