Genmab Announces Rinatabart Sesutecan (Rina-S®) Demonstrates Statistically Significant Improvement in Progression-Free Survival and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer
Key Highlights
- ➤Rina-S cut progression or death risk 71% in ITT population (HR 0.29; p<0.0001)
- ➤Rina-S improved overall survival in ITT population (HR 0.43; p<0.0001)
- ➤RAINFOL-02 met PFS and OS endpoints in platinum-resistant ovarian cancer
- ➤Rina-S showed 67% lower progression or death risk in PAS population (HR 0.33; p<0.0001)
- ➤Genmab plans regulatory discussions and future medical-meeting data presentation
Expert Statements
Jan van de Winkel, Chief Executive Officer of Genmab
“As the first Phase 3 readout from our Rina-S program, the positive topline results from RAINFOL-02 mark a significant milestone for Genmab and strengthen our confidence in Rina-S’s potential for patients with platinum-resistant ovarian cancer. These results advance our ambition to become a leader in gynecologic oncology and reflect our commitment to improving the lives of patients with high unmet medical needs”
Angeles Alvarez Secord, MD, MHSc, study’s lead investigator for the Gynecologic Oncology Group and Professor of Obstetrics and Gynecology at the Duke Cancer Institute
“Platinum-resistant ovarian cancer remains one of the greatest challenges in gynecologic oncology, with patients often facing a poor prognosis and limited effective treatment options. The Phase 3 RAINFOL-02 results set a new benchmark in addressing this urgent unmet need regardless of FRα expression”
Angeles Alvarez Secord, MD, MHSc, study’s lead investigator for the Gynecologic Oncology Group and Professor of Obstetrics and Gynecology at the Duke Cancer Institute
“The 71% reduction in the risk of disease progression and 57% reduction in the risk of death underscore the potential of Rina-S to change clinical practice if approved by offering a therapeutic option for a broad patient population.”
COPENHAGEN, Denmark; October 23, 2026 * 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.
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