TP023/#1560 A phase 3, randomized, double-blind, placebo/paclitaxel-controlled study of batiraxcept in combination with weekly paclitaxel in patients with platinum-resistant recurrent ovarian cancer (GOG-3059/ENGOT OV-66). (4th December 2022)

• Record Type: Journal Article
• Authors: Fuh, Katherine; Moore, Kathleen; Baert, Thais; Herzog, Thomas; Cibula, David; Liu, Joyce; Eberst, Laurianne; Lewin, Sharon; Secord, Angeles Alvarez; Sehouli, Jalid; Myers, Tashanna; Bamias, Aristotelis; Rimel, BJ; Colombo, Nicoletta; Franke, Amy; Shoop, Dipti; Giorgi, Ugo De; Pikiel, Joanna; Bowen, Rebecca; Gonzalez-Martin, Antonio
• Is Part Of: International journal of gynecological cancer. Volume 32(2022)Supplement 3
• Page Start: A234
• Page End: A235
• Publication Date: 2022-12-04
• Subjects: Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2022-igcs.532
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Objectives: Introduction: The AXL receptor and its sole activating ligand, GAS6, are important drivers of metastasis and therapeutic resistance in human cancers. This signaling axis represents an attractive target for therapeutic intervention. The strong picomolar binding affinity between endogenous GAS6 and AXL and the promiscuity of small molecule AXL inhibitors have presented a barrier to specific and potent inhibition of AXL. Batiraxcept (AVB-S6–500) is a recombinant fusion protein with ~200-fold higher affinity for GAS6 than wild-type (WT) AXL. Batiraxcept binds GAS6, inhibiting its interaction with AXL thereby dramatically reducing AXL signaled invasion and migration of highly metastatic cells in vitro and inhibiting metastatic disease in nonclinical models of aggressive human cancers. The Phase 1b study showed no DLTs and established a RP2D of 15 mg/kg IV every 2 weeks with PAC/PLD. Longer PFS and OS times were observed in patients who had not been previously treated with bevacizumab (bev-naïve). Methods: High-grade serous PROC, who received 1–4 prior lines randomized (1:1) batiraxcept/PAC or placebo/PAC; stratified by last platinum regimen, prior lines, and prior bevacizumab. The primary endpoint is PFS by RECIST v1.1 assessed by the investigator with OS a secondary endpoint. The primary PFS analysis will be triggered when 130 PFS events occur in the bev-naïve; with an interim analysis of OS. Recruitment began April 2021; 252 of ~350 patients have been randomized globally (132 sites) (NCT04729608 ). Results: Trial in progress: there are no available results at the time of submission Conclusions: Trial in progress: there are no available conclusions at the time of submission