Aravive (NASDAQ:ARAV) reported positive new data from the Phase 1b portion of an ongoing Phase 1b/2 trial of batiraxcept in clear cell renal cell cancer (ccRCC) and new data from a biomarker high subgroup.
Key findings include:
- No dose limiting toxicities observed at either the 15 mg/kg or 20 mg/kg batiraxcept dose in combination with cabozantinib.
- At a median follow-up of 4.9 months on February 4, 2022, 92% of patients remain on study.
- Best overall response rate (ORR) in the intent-to-treat (iTT) population is 46% (12/26 patients).
- In the 15 mg/kg population, best ORR is 56% (9/16).
- In the 20 mg/kg population, best ORR is 30% (3/10).
- No patient has had progressive disease as their best response.
- The six-month progression-free survival rate in the iTT population is 79%.
- Median duration of response has not been reached.
The safety and clinical activity data continue to support 15 mg/kg batiraxcept as an appropriate dose to study in combination with cabozantinib in the Phase 2 ccRCC portion of the study.
“We are very encouraged by the best overall response rate and six-month progression-free survival rate observed in the Phase 1b trial of batiraxcept in patients with ccRCC,” Kathryn Beckermann, M.D., Ph.D., assistant professor, division of hematology and oncology, Vanderbilt University Medical Center, and lead investigator for the trial.
“These early data suggest batiraxcept adds to cabozantinib clinical activity and potentially provides a much-needed therapy for this group of patients with refractory clear cell renal cell carcinoma,” she added.
