Treatment with batiraxcept plus paclitaxel did not produce any new safety signals among patients with platinum-resistant ovarian cancer in the phase 3 AXLerate-OC trial.
Combining batiraxcept with paclitaxel did not improve progression-free survival (PFS) over paclitaxel alone in a subset of patients with bevacizumab (Avastin)–naïve, platinum-resistant ovarian cancer, according to a press release on topline results from the phase 3 AXLerate-OC trial (NCT04729608).1
The median PFS was 5.4 months with batiraxcept plus paclitaxel vs 5.4 months with paclitaxel alone in the bevacizumab-naïve population (n = 179). In the overall population (n = 366), the median PFS in each respective arm was 5.1 months vs 5.5 months. Investigators noted that the difference in PFS outcomes was not statistically significant between treatment arms.
The safety profile of batiraxcept in the AXLerate-OC trial was comparable with previous reports of the agent. Additionally, the study treatment did not raise any new safety signals.
“We are conducting additional analyses on the phase 3 AXLerate-OC 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 [RCC] and pancreatic cancer,” Gail McIntyre PhD, DABT, president and chief executive officer at Aravive, said in the press release.
Investigators of the international, double-blind, randomized phase 3 AXLerate-OC/GOG-3059/ENGOT OV-66 trial assessed the safety and efficacy of batiraxcept among patients with platinum-resistant ovarian cancer. Patients were randomly assigned to receive 15 mg/kg of batiraxcept or matched placebo plus paclitaxel across 165 treatment sites in the U.S. and Europe.
The primary end point of the trial was PFS. Overall survival was a secondary end point, and exploratory end points included duration of response, objective response rate (ORR), treatment-emergent adverse effects, quality of life, clinical benefit rate, and pharmacokinetics.
Patients 18 years and older with histologically confirmed recurrent ovarian, fallopian tube, or peritoneal cancer and high-grade serous adenocarcinoma histology were eligible for enrollment on the trial. Additional eligibility criteria included having an ECOG performance status of 0 or 1, platinum-resistant disease, archived tumor tissue, receiving 1 to 4 prior lines of therapy, and having measurable disease based on RECIST v1.1 criteria. Patients also needed to have normal gastrointestinal function and full recovery from treatment-related toxicities of grade 1 or less to enroll on the trial.
Those with tumors in the breast or bone, or untreated central nervous system metastases were not able to enroll on the trial. Patients were also ineligible for enrollment if they received concurrent anti-cancer therapy for underlying ovarian cancer, prior paclitaxel in the platinum-resistant recurrent setting, or had evidence of clinically significant third spacing requiring therapeutic intervention within 28 days of beginning study treatment.
“Although [the] AXLerate-OC [trial] 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,” Katherine Fuh, MD, PhD, an associate professor in the University of California San Francisco Division of Gynecologic Oncology, said.
The FDA previously granted fast track designation (FTD) to batiraxcept in November 2022 for patients with clear cell RCC that has progressed following 1 or 2 previous lines of systemic therapy.2 Supporting data for the FTD came from the phase 1b portion of the phase 1/2AVB500-RCC-003 trial (NCT04300140) in which batiraxcept plus cabozantinib (Cabometyx) elicited a median PFS of 11.4 months and an ORR of 57%.