Genmab: Rinatabart Sesutecan (Rina‑S) significantly improves PFS and OS in platinum‑resistant ovarian cancer
- RAINFOL‑02 randomized 584 patients (ITT) with 492 in the primary analysis set (PAS).
- Rina‑S reduced risk of progression or death by 71% in the ITT population (HR 0.29; 95% CI 0.23–0.37; p<0.0001) and 67% in the PAS (HR 0.33; 95% CI 0.26–0.42; p<0.0001).
- Rina‑S improved overall survival: HR 0.43 in ITT (95% CI 0.31–0.59; p<0.0001) and HR 0.44 in PAS (95% CI 0.31–0.63; p<0.0001).
- Observed safety profile was consistent with known Rina‑S profile; no new safety signals identified; dose used was 120 mg/m² every 3 weeks.
Trial and design
RAINFOL‑02 is a randomized, open‑label, multicenter Phase 3 study comparing rinatabart sesutecan (Rina‑S) 120 mg/m² on Day 1 of each three‑week cycle with investigator’s choice chemotherapy (paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine) in platinum‑resistant ovarian cancer. The intent‑to‑treat (ITT) population included 584 randomized patients; the primary analysis set (PAS) included 492 patients and accounted for FRα expression and prior mirvetuximab exposure as specified in the protocol.
Primary and key secondary endpoints
Rina‑S met the primary endpoint of progression‑free survival. In the ITT population Rina‑S reduced the risk of disease progression or death by 71% (HR 0.29; 95% CI 0.23–0.37; p<0.0001), and by 67% in the PAS (HR 0.33; 95% CI 0.26–0.42; p<0.0001). The trial also met its key secondary endpoint of overall survival, with HR 0.43 in the ITT population (95% CI 0.31–0.59; p<0.0001) and HR 0.44 in the PAS (95% CI 0.31–0.63; p<0.0001).
Safety and next steps
The observed safety profile was consistent with the known profile of Rina‑S and no new safety signals or unexpected safety concerns were identified. Genmab plans to engage regulatory authorities worldwide regarding next steps, will submit the data for presentation at a future medical meeting, and will host an investor update on 28 October at 17:00 CET / 12:00 EDT.
Source: Genmab