REG-Genmab Announces Rinatabart Sesutecan (Rina-S®) Demonstrates Statistically Significant Improvement in Progression-Free Survival and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer
Genmab's Phase 3 RAINFOL-02 trial of Rina-S in platinum-resistant ovarian cancer met its primary PFS endpoint and its key secondary OS endpoint with statistical significance, showing a 71% reduction in the risk of progression or death in the intent-to-treat population (HR 0.29) and a 57% reduction in the risk of death (OS HR 0.43). This is the first Phase 3 readout from the Rina-S program, and efficacy held regardless of FRα expression level or prior mirvetuximab treatment, positioning Rina-S for a broad patient population in a setting with poor prognosis and limited options.
Key figures
- Drug Name
- Rinatabart Sesutecan (Rina-S; GEN1184)
- Phase Of Trial
- Phase 3
- Os hr itt
- 0.43 (95% CI, 0.31-0.59; p<0.0001)
- 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)
- Pfs hr pas
- 0.33 (95% CI, 0.26-0.42; p<0.0001)
- Itt population
- N=584
- Pas population
- N=492
AI analysis
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