On November 29, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s lead program, batiraxcept, for treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology (IO)-based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies (either in combination or sequentially) (Press release, Aravive, NOV 29, 2022, View Source [SID1234624553]).
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Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug’s development plan, including the design of the proposed clinical trials, use of biomarkers and the extent of data needed to support approval. Drugs with Fast Track Designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
The Fast Track Designation was based on new data submitted to the agency from the P1b clear cell renal cell cancer (ccRCC) study (AVB500-RCC-003; NCT04300140). As of September 26, 2022, 26 previously treated (second line or greater) patients with ccRCC have been treated with batiraxcept in the Phase 1b portion of a Phase 1b/2 trial at doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus cabozantinib 60 mg daily. There were no dose limiting toxicities observed at either dose. Clinical data from this study demonstrate that batiraxcept has the potential to increase the clinical activity of cabozantinib in patients with metastatic ccRCC who have progressed following IO- and VEGF-TKI-based therapies (N=14 of the 26 patients) as the Objective Response Rate (ORR) was 57% and median Progression-Free Survival (PFS) was 11.4 months in this population.
"The majority of patients with kidney cancer develop resistance to frontline treatment and there is a clinical need for novel agents to improve upon treatment options in the refractory setting," said Kathryn Beckermann, M.D., Ph.D., Assistant Professor, Division of Hematology and Oncology, Vanderbilt University Medical Center, and lead investigator for the trial. "Response rates to single agent targeted kinase inhibitors are approximately 30% with a PFS of approximately 7 months. The early data seen with batiraxcept including biomarker development, response rate, and progression-free survival are promising."
"A review of the literature suggests that the clinical activity of cabozantinib is lower in those patients who have progressed following a VEGF-TKI-based therapy compared to patients who have progressed on IO or IO/IO therapy. Since preclinical data published by Xiao in 20191 observed that batiraxcept may restore TKI sensitivity, it makes sense that the combination of batiraxcept and cabozantinib may exhibit its greatest impact in those patients who have failed prior VEGF-TKI therapies," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Understanding the P1b ccRCC data has allowed us to identify the most appropriate patient population in which to evaluate batiraxcept in combination with cabozantinib and potentially the quickest path to approval in this population with an unmet medical need."