The story so far
written Oct 26What is happening
Genmab reported on October 23, 2026, that its Phase 3 RAINFOL-02 trial for the ovarian cancer treatment rinatabart sesutecan (Rina-S) met its primary and key secondary endpoints 46. The therapy reduced the risk of disease progression or death by 71% and the risk of death by 57% compared to standard chemotherapy in 584 patients with platinum-resistant ovarian cancer 126. These results applied to the intent-to-treat population regardless of folate receptor alpha (FRα) expression levels 26.
Analysts at Truist Securities and William Blair noted the 57% reduction in death risk exceeds the 33% reduction previously reported for a competing treatment, Elahere 1. While the trial showed no safety signals for ocular toxicity, nausea affected 67.9% of participants and neutropenia affected 57.8% 9.
What to watch
Genmab plans to discuss the RAINFOL-02 findings with global regulatory authorities and present the data at a future medical meeting 56. The company is currently evaluating Rina-S in five Phase 3 trials across various gynecologic cancers, including endometrial and first-line ovarian cancer maintenance 5.
Regulatory approval granted by the U.S. FDA or the European Medicines Agency (EMA) would settle the drug's status in those markets. A commercial launch announced by Genmab or a partner company, or a reimbursement decision published by a major health-technology assessment body, would establish its availability to patients.
Read the full brief · how we got here
References · 8
- 1biospace.com — Genmab’s ADC beats survival expectations in Phase 3 ovarian cancer trial - BioSpace
- 2european-biotechnology.com — Genmab’s acquisition spree starts to pay off with new ovarian and colorectal cancer data - European Biotechnology Magazine
- 4gurufocus.com — Genmab (GMAB) Reports Positive Phase 3 RAINFOL-02 Trial Results for Ovarian Cancer Therapy
- 5investing.com — Genmab’s ovarian cancer drug meets phase 3 trial goals By Investing.com
- 6globenewswire.com — Genmab Announces Rinatabart Sesutecan (Rina-S®) Demonstrates Statistically Significant Improvement in Progression-Free Survival and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer
- 8streetinsider.com — Ovarian Cancer Pipeline 2026: Emerging Drugs, Regulatory Milestones, and Strategic Moves by Leading Players | Pfizer, Daiichi Sankyo, Astellas Pharma, Jiangsu HengRui, Boehringer Ingelheim, Impact
- 9mugglehead.com — Genmab A/S reports 45.9% Rina‑S response in ovarian cancer trial
- 11cancernetwork.com — EMA Accepts Application for Mirvetuximab Soravtansine in Ovarian Cancer | CancerNetwork
What would close this
0 of 4 metTimeline
1newest firstWhen we started following: Genmab to seek regulatory meetings after Rina-S cuts ovarian cancer death risk by 57% in Phase 3 trial
Genmab announced on October 23, 2026, that its Phase 3 RAINFOL-02 trial of rinatabart sesutecan (Rina-S) met its primary and key secondary endpoints in patients with platinum-resistant ovarian cancer 46. The therapy reduced the risk of disease progression or death by 71% and the risk of death by 57% compared to standard chemotherapy 12. These results occurred in the intent-to-treat population of 584 patients regardless of folate receptor alpha (FRα) expression levels 26.
Genmab plans to discuss these findings with global regulatory authorities and present the data at a future medical meeting 56. The company is currently evaluating Rina-S in five Phase 3 trials across various gynecologic cancers, including endometrial and first-line ovarian cancer maintenance 5. Analysts at Truist Securities and William Blair noted the data exceeds the 33% death risk reduction previously reported for AbbVie’s competing treatment, Elahere 1.
Earlier in October 2026, Genmab reported a 45.9% objective response rate from the Phase 2 RAINFOL-01 trial 89. While the drug showed no safety signals for ocular toxicity, nausea affected 67.9% of participants and neutropenia affected 57.8% 9. Separately, the European Medicines Agency accepted a marketing authorization application for AbbVie's Elahere on October 8, 2026 11.