Photo Credit: Lars Neumann

Results from the Phase 3 AXLerate-OC trial showed that the combination of batiraxcept and paclitaxel demonstrated a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to paclitaxel alone.

AXL is a receptor tyrosine kinase that is often overexpressed in cancers. It contributes to pathophysiology in cancer progression and therapeutic resistance, making it an emerging therapeutic target¹. Batiraxcept is a highly sensitive and specific inhibitor of AXL. When combined with chemotherapy, this compound has shown efficacy in treatment of ovarian cancer in pre-clinical models^2.3.

The randomized, double-blind, phase 3 AXLerate-OC trial (NCT04729608) evaluated the clinical effectiveness of combining batiraxcept with paclitaxel in patients with platinum-resistant, recurrent, high-grade serous ovarian cancer. Primary endpoint was PFS in the total population and the exploratory endpoint was PFS in high-AXL expression. Dr. Katherine Fuh (University of California San Francisco, CA, USA) presented the results⁴.

A total of 360 patients were 1:1 randomly assigned to paclitaxel plus batiraxcept or paclitaxel plus placebo. In the total population, no difference was observed in median PFS between participants treated with batiraxcept versus placebo: 5.13 (95% CI 4.16-6.1months) versus 5.49 (95% CI 5.27-5.7) months (HR 1.16; P=0.207). In addition, no difference was observed in median OS: 14.29 (95% CI: 12.5-16.0) months versus 14.39 (95% CI 12.7-16.0) months (HR1.07; P=0.689).

However, in participants with high AXL-expression (n=61), defined as under or equal to 80% intensity on immunohistochemistry, median PFS was significantly improved by adding batiraxcept: 5.78 (95% CI 5.1-6.4) months versus 3.71 (95% CI 3.0-4.4) months (HR 0.55; P=0.042). Likewise, median OS in the high-AXL population was improved by adding batiraxcept: 17.81 (95% CI 12.8- 22.8) months versus 8.11(95% CI 6.7-9.6) months (HR 0.32; P=0.006).

“Compared to paclitaxel alone, combination of batiraxcept and paclitaxel is promising in patients with high AXL-expressing, platinum-resistant ovarian cancer”, Dr. Fuh concluded. However, due to low numbers, confirmation of these results is warranted in a more powerful trial.

Medical writing support was provided by Marten Dooper, PhD.
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