- Phase 3 RAINFOL™-02 trial met its primary endpoint of progression-free survival (PFS) and its key secondary endpoint of overall survival (OS) with rinatabart sesutecan (Rina-S®) compared to investigator’s choice chemotherapy
- Results demonstrated statistically significant and clinically meaningful improvement in PFS and OS in patients with platinum-resistant ovarian cancer (PROC)
- Data will be submitted for presentation at a future medical meeting and discussed with regulatory authorities worldwide
Genmab A/S (NASDAQ:GMAB) announced today positive topline results from the global Phase 3 RAINFOL™-02 trial of rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), in patients with platinum-resistant ovarian cancer (PROC) regardless of FRα expression level or prior treatment with mirvetuximab. The trial met its primary endpoint of progression-free survival (PFS), with Rina-S demonstrating a statistically significant and clinically meaningful improvement compared with investigator’s choice chemotherapy in the intent-to-treat (ITT) and in the primary analysis set (PAS) populations.
The ITT population (N=584) comprised of all randomized patients with PROC, regardless of FRα expression. The PAS population (N=492) mandated patients with FRα expression ≥75% PS2+ to have been treated with mirvetuximab.
In the ITT population, Rina-S demonstrated a 71% reduction in the risk of disease progression or death (HR 0.29; 95% CI, 0.23-0.37; p<0.0001). In the PAS population, Rina-S demonstrated a 67% reduction in the risk of disease progression or death (HR 0.33; 95% CI, 0.26–0.42; p<0.0001).
The study also met its key secondary endpoint of overall survival (OS), demonstrating a statically significant and clinically meaningful improvement in the ITT population (HR 0.43; 95% CI, 0.31–0.59; p<0.0001) and in the PAS population (HR 0.44; 95% CI, 0.31–0.63; p<0.0001).
The observed safety profile was consistent with the known profile of Rina-S, with no new safety signals or unexpected safety concerns identified.