On January 4, 2023 Aravive, Inc. (Nasdaq: ARAV, the "Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that the achievement of full enrollment in the registrational Phase 3 trial of batiraxcept plus paclitaxel for platinum-resistant ovarian cancer (PROC)(Press release, Aravive, JAN 4, 2023, View Source [SID1234625784]). The global, randomized, double-blind, placebo-controlled Phase 3 AXLerate-OC trial is evaluating efficacy and tolerability of 15 mg/kg batiraxcept in combination with weekly paclitaxel versus placebo in combination with weekly paclitaxel. The trial was planned to enroll approximately 350 patients with platinum resistant, high grade serous ovarian cancer who received 1-4 prior lines of therapy at approximately 165 sites in the U.S. and Europe.
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"Completing enrollment of this pivotal study brings us closer to the day when batiraxcept potentially is available to patients," said Scott Dove, Ph.D., Chief Operating Officer of Aravive. "Public reporting of topline data remains on track for mid-2023 and, if successful, are expected to support a Biologics License Application for PROC at the end of 2023. I would like to thank the patients enrolled in the trial, the clinical investigators, our CRO partners, and the Aravive team who worked tirelessly to advance the trial to this stage."
"The majority of patients with ovarian cancer will develop platinum resistance and have residual side effects from previous treatments," said Katherine Fuh, MD, PhD, John A. Kerner Chair in Gynecologic Oncology, Associate Professor, Department of OB/GYN, Director of Basic and Translational Research, Division of Gynecologic Oncology, University of California, San Francisco. "There is a need to develop effective novel agents with little to no side effects. As overall response rates for current treatments in platinum-resistant ovarian cancer range from 4% to 30%, we anticipate that batiraxcept and paclitaxel could be an option for our patients."