- RAINFOL-01 cohort D2: 40 patients received rinatabart sesutecan (Rina‑S) 120 mg/m2 plus bevacizumab every 3 weeks; primary endpoint was safety.
- Common TEAEs: nausea 80%, fatigue 67.5%, anemia 55%, neutropenia 45%; serious TEAEs 15%, dose reductions 27.5%, discontinuations 5%, no fatal TEAEs or new safety signals.
- Rina‑S is an FRα-targeted antibody–drug conjugate carrying exatecan, a topoisomerase I inhibitor.
- Phase 3 RAINFOL‑04 is ongoing to evaluate Rina‑S plus bevacizumab as maintenance in recurrent platinum‑sensitive ovarian cancer.
Study design and dosing
Data from cohort D2 of the Phase 1/2 RAINFOL-01 trial evaluated rinatabart sesutecan (Rina‑S) plus bevacizumab in 40 patients with recurrent advanced ovarian cancer; Rina‑S was administered at 120 mg/m2 every three weeks with bevacizumab until progression or unacceptable toxicity, with safety and tolerability as the primary endpoint.
Safety and tolerability
The combination was tolerable with no new safety signals; common treatment‑emergent AEs (≥25%) were nausea (80%), fatigue (67.5%), anemia (55%) and neutropenia (45%); serious TEAEs occurred in 15% of patients, 27.5% required Rina‑S dose reductions, 5% discontinued treatment, and no fatal TEAEs were reported; no ocular toxicity, peripheral neuropathy, interstitial lung disease signals or clinically significant bleeding were observed.
Drug profile and development
Rina‑S is an investigational FRα‑targeted antibody–drug conjugate with a hydrophilic protease‑cleavable linker and exatecan (topoisomerase I inhibitor) payload; a Phase 3 program is ongoing, including RAINFOL‑04 evaluating the Rina‑S plus bevacizumab combination as maintenance in recurrent platinum‑sensitive ovarian cancer.
