Phase 3 torvutatug samrotecan FRα (FOLR1) ADC with exatecan (topoisomerase I) payload

AstraZeneca’s TREVI-OC-03 is a randomized, open-label Phase 3 maintenance study testing torvutatug samrotecan (torvu-sam; AZD5335), a folate receptor alpha (FRα/FOLR1)–directed monoclonal antibody–drug conjugate delivering an exatecan-class topoisomerase I inhibitor payload. Participants with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (second- or third-line setting) are assigned to torvu-sam alone or torvu-sam plus bevacizumab, versus standard-of-care maintenance (observation or bevacizumab), with efficacy and safety endpoints typical for maintenance programs (e.g., progression-based outcomes and tolerability). Bevacizumab (Avastin; anti-VEGF monoclonal antibody, marketed by Genentech/Roche with biosimilars such as Vegzelma) is included to test whether angiogenesis inhibition adds to FRα-targeted cytotoxic delivery. The commercial/scientific angle is a pivotal readout for an FRα-directed Topo1 ADC in a maintenance window—an increasingly competitive space shaped by PARP inhibitors and bevacizumab. Today, after response to platinum in platinum-sensitive relapse, maintenance may include bevacizumab after a bevacizumab-containing platinum regimen, while PARP maintenance in the recurrent setting is now used more selectively, particularly according to BRCA status and prior PARP exposure. This trial asks whether an FRα-ADC can extend disease control beyond those options.