Genmab (GMAB) Study result summary

Efficacy results

• Phase 3 RAINFOL-02 met its primary endpoint of investigator-assessed PFS and key secondary endpoint of OS in platinum-resistant ovarian cancer.

• ITT population (N=584): Rina-S reduced risk of progression or death by 71% vs investigator’s choice chemotherapy (HR 0.29; 95% CI 0.23–0.37; p<0.0001).

• PAS population (N=492): risk of progression or death was reduced by 67% (HR 0.33; 95% CI 0.26–0.42; p<0.0001).

• OS improved significantly in ITT (HR 0.43; 95% CI 0.31–0.59; p<0.0001) and PAS (HR 0.44; 95% CI 0.31–0.63; p<0.0001).

Trial and safety

• Randomized, open-label Phase 3 study compared Rina-S with investigator’s choice of paclitaxel, topotecan, PLD or gemcitabine in patients with platinum-resistant ovarian cancer, regardless of FRα expression.

• ITT included all randomized patients; PAS included patients with FRα expression <75% PS2+ and eligible patients with expression ≥75% PS2+ previously treated with mirvetuximab.

• Observed safety profile was consistent with Rina-S’s known profile, with no new safety signals or unexpected safety concerns.

Next steps

• Results will be submitted for presentation at a future medical meeting, with discussions planned with regulatory authorities worldwide.

• Rina-S is investigational; its broader development program includes Phase 3 studies in ovarian and endometrial cancers and trials in other solid tumors.