Batiraxcept shows promise in high AXL-expressing, platinum-resistant ovarian cancer

The combination of batiraxcept and paclitaxel compared with paclitaxel alone was associated with statistically significant improvements in progression-free survival (PFS) and overall survival (OS) in patients with platinum-resistant, ovarian cancer with a high AXL expression, which was an exploratory endpoint in the phase 3 AXLerate-OC trial.

AXL is a receptor tyrosine kinase often overexpressed in cancer. Contributing to the pathophysiology of cancer progression and therapeutic resistance, it is an emerging therapeutic target [1]. Batiraxcept is a highly sensitive and specific inhibitor of AXL. When combined with chemotherapy, this compound has shown efficacy in the treatment of ovarian cancer in pre-clinical models [2,3].

The randomised, 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. The 360 participants were 1:1 randomised to paclitaxel plus batiraxcept or paclitaxel plus placebo. The primary endpoint was PFS in the total population, and an exploratory endpoint was PFS in high-AXL-expressing patients. Dr Katherine Fuh (University of California San Francisco, CA, USA) presented the results [4].

In the total population, no difference was observed in median PFS between participants treated with batiraxcept versus placebo: 5.13 versus 5.49 months (HR 1.16; P=0.207). In addition, no difference was observed in median OS: 14.29 versus 14.39 months (HR 1.07; P=0.689).

However, in participants with a high AXL expression (n=61), defined as ≥80% intensity on immunohistochemistry, the median PFS was significantly improved by the addition of batiraxcept: 5.78 versus 3.71 months (HR 0.55; 95% CI 0.31–0.98; P=0.042). Likewise, the median OS in the high-AXL-expressing population was improved by the addition of batiraxcept: 17.81 versus 8.11 months (HR 0.32; 95% CI 0.14–0.73; P=0.006; see Figure).

Figure: Overall survival in high-AXL-expressing participants of AXLerate-OC [4]



“Compared with paclitaxel alone, the combination of batiraxcept and paclitaxel is promising in patients with high-AXL-expressing, platinum-resistant ovarian cancer,” Dr Fuh concluded. However, because of the small size, confirmation of these results is warranted in a more powered trial.

1. Cardone C, et al. Eur. J. Cancer. 2020;138:1-10.
2. Fuh KC, et al. Gynecol Oncol. 2021;163:254-261.
3. Mullen MM, et al. Mol. Cancer Res. 2022;20:265-279.
4. Fuh KC, et al. AXLerate-OC/GOG-3059/ENGOT OV-66: results of a phase 3, randomized, double-blind, placebo-controlled study of batiraxcept (AVB-500)/placebo in combination with paclitaxel in patients with platinum-resistant recurrent ovarian cancer. Abstract LBA5515, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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Posted on 18 July 202419 July 2024