Phase 3 TREVI-OC-02 tests FRα-targeted torvutatug samrotecan plus bevacizumab maintenance in HRD-negative ovarian cancer

AstraZeneca’s TREVI-OC-02 is a randomized, open-label Phase 3 trial comparing torvutatug samrotecan (torvu-sam) plus bevacizumab with bevacizumab alone as first-line maintenance. Torvu-sam is a folate receptor alpha (FRα/FOLR1)-directed antibody-drug conjugate carrying an exatecan-class topoisomerase I inhibitor payload; bevacizumab blocks VEGF-driven angiogenesis.

The study enrolls newly diagnosed stage III/IV high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer with HRD-negative disease and no progression after first-line platinum-based treatment. Eligibility requires 6-8 platinum-based cycles, including bevacizumab during at least the last 3 cycles, rather than allowing any prior frontline regimen. The primary question is whether adding the ADC prolongs progression-free survival beyond bevacizumab maintenance. This addresses a group in which PARP-inhibitor maintenance has generally offered less benefit than in HRD-positive disease. Tumor tissue is assessed for FRα, while the trial evaluates whether targeted payload delivery can add useful maintenance activity without excessive toxicity.