Batiraxcept Gains Fast Track Designation in Previously Treated ccRCC

Batiraxcept has received Fast Trask Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma (RCC) who had progressed after one or more prior lines of therapy, including an immunotherapy-based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapy.

Batiraxcept is a soluble fusion protein comprised of the extracellular domain of the receptor tyrosine kinase (RTK) AXL (UFO) fused to a human immunoglobulin G1 (IgG1) Fc domain, with potential antineoplastic activity.

This new designation was based on data from a phase-1b study that enrolled 26 patients with previously treated disease. Patients were treated with 15 mg/kg or 20 mg/kg combined with cabozantinib 60 mg daily.

Among patients with metastatic clear cell RCC who progressed on both immunotherapy- and VEGF-TKI-based therapy, the objective response rate was 57% with a median progression-free survival of 11.4 months. No dose-limiting toxicities occurred at either dose level studied.

The results, released by the manufacturer in March, also showed a 46% best overall response rate in the study’s intention-to-treat population, with a 6-month progression-free survival of 79%.

“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, MD, PhD, 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 progression-free survival of approximately 7 months. The early data seen with batiraxcept including biomarker development, response rate, and progression-free survival are promising.”

References

Aravive Announces Fast Track Designation of Batiraxcept for Treatment of ccRCC

Aravive Announces Positive Updated Data and New Biomarker Data From Phase 1b Study of Batiraxcept in Clear Cell Renal Cell Carcinoma