GENMAB A/S (GMAB) Form 6-K — Oct 23, 2026
Genmab announced that its Phase 3 RAINFOL-02 trial of rinatabart sesutecan (Rina-S) met its primary endpoint of progression-free survival and its key secondary endpoint of overall survival in platinum-resistant ovarian cancer. In the intent-to-treat population (N=584), Rina-S showed a 71% reduction in the risk of progression or death (HR 0.29; p<0.0001) and a 57% reduction in the risk of death (HR 0.43; p<0.0001), with results consistent regardless of FRα expression level or prior mirvetuximab treatment. The safety profile was consistent with the known profile of Rina-S, with no new safety signals identified.
Key figures
- Dose
- 120 mg/m2 on Day 1 of each three-week cycle
- Os hr itt
- 0.43 (95% CI, 0.31-0.59; p<0.0001) — 57% reduction in risk of death
- Os hr pas
- 0.44 (95% CI, 0.31-0.63; p<0.0001)
- Pfs hr itt
- 0.29 (95% CI, 0.23-0.37; p<0.0001) — 71% reduction in risk of progression or death
- Pfs hr pas
- 0.33 (95% CI, 0.26-0.42; p<0.0001) — 67% reduction
- Itt population n
- 584
- Pas population n
- 492
- Phase3 trials in program
- 5
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