RAINFOL-02 is the first Phase 3 readout from the Rina-S programme, and Genmab A/S said on 23 October 2026 that the global trial of rinatabart sesutecan (Rina-S) in platinum-resistant ovarian cancer met its primary endpoint of progression-free survival (PFS) and its key secondary endpoint of overall survival (OS), against investigator's choice chemotherapy. Rina-S is an investigational antibody-drug conjugate that targets folate receptor alpha (FRα) and carries a topoisomerase I inhibitor payload. The open-label trial enrolled patients regardless of FRα expression level. Patients were randomised 1:1 to Rina-S every three weeks or to one of four chemotherapy agents: paclitaxel, topotecan, PLD or gemcitabine.
- Progression-free survival hazard ratio, ITT population · 23 October 2026 (topline)0.29 71% lower risk of progression or death
- Overall survival hazard ratio, ITT population · 23 October 2026 (topline)0.43 p<0.0001
- Patients in ITT population · 23 October 2026584
- Phase 3 trials in the Rina-S programme · 23 October 20265
| Endpoint and population | Hazard ratio | 95% CI | p-value |
|---|---|---|---|
| PFS (primary), ITT, N=584 | 0.29 | 0.23-0.37 | <0.0001 |
| PFS (primary), PAS, N=492 | 0.33 | 0.26-0.42 | <0.0001 |
| OS (key secondary), ITT | 0.43 | 0.31-0.59 | <0.0001 |
| OS (key secondary), PAS | 0.44 | 0.31-0.63 | <0.0001 |
Source: Genmab Company Announcement no. 43, 23 October 2026, 23 October 2026. Topline results as announced by Genmab. The primary endpoint is investigator-assessed PFS.
Overall survival had a hazard ratio of 0.43 in the intent-to-treat (ITT) population. Angeles Alvarez Secord, the study's lead investigator for the Gynecologic Oncology Group and Professor of Obstetrics and Gynecology at the Duke Cancer Institute, described the OS result in the announcement as a 57% reduction in the risk of death. Genmab said the observed safety profile was consistent with the drug's known profile, with no new safety signals.
Genmab plans to discuss the results and potential next steps with regulatory authorities worldwide and to submit the data for presentation at a future medical meeting. It has not given a date for either. The company states that the safety and efficacy of Rina-S have not been established.
- RAINFOL-02: platinum-resistant ovarian cancer (reported 23 October 2026)
- RAINFOL-03: recurrent or progressive endometrial cancer
- RAINFOL-04: platinum-sensitive ovarian cancer maintenance therapy
- RAINFOL-07: second-line platinum-sensitive ovarian cancer
- RAINFOL-10: first-line ovarian cancer maintenance therapy
- Genmab A/S, Company Announcement no. 43 on RAINFOL-02 topline results (GlobeNewswire), 23 Oct 2026, 17:55 CEST
- Genmab A/S, Company Announcement no. 43 (Form 6-K, Exhibit 99.1), 23 Oct 2026, 17:58 CEST