Genmab: Rinatabart Sesutecan (Rina‑S) shows durable responses in platinum‑resistant ovarian cancer
- 109 patients with platinum‑resistant ovarian cancer treated with Rina‑S 120 mg/m² every three weeks as monotherapy.
- Confirmed ORR 45.9% (95% CI 36.3–55.7), including five complete responses.
- Median duration of response 12.1 months (95% CI 6.5–15.4); 51% of responders remained in response at one year; median PFS 9.5 months (95% CI 7.6–11.3).
- Common TEAEs: nausea 67.9%, fatigue 57.8%; anemia and neutropenia 57.8% each; serious adverse events in ~33%; treatment discontinuation for TEAEs 5.5%.
Key efficacy results
In Part C of the Phase 1/2 RAINFOL‑01 trial, 109 patients with platinum‑resistant ovarian cancer treated with rinatabart sesutecan (Rina‑S) 120 mg/m² Q3W achieved a confirmed objective response rate of 45.9% (95% CI: 36.3–55.7), including five complete responses. Median duration of response was 12.1 months (95% CI: 6.5–15.4) with 51% of responders in response at one year. Median progression‑free survival was 9.5 months (95% CI: 7.6–11.3). These findings were presented at the IGCS Congress 2026.
Patient cohort and prior therapies
The cohort included patients with platinum‑resistant high‑grade serous ovarian, primary peritoneal, or fallopian tube cancer who had received one to three prior lines of therapy (up to four if mirvetuximab was the most recent therapy); 53% had three or four prior lines. All patients had prior bevacizumab and taxane exposure; 49.5% had received a prior PARP inhibitor and 33% prior mirvetuximab soravtansine. Antitumor activity was observed regardless of folate receptor alpha (FRα) expression, including low expressors and non‑expressors, and irrespective of prior mirvetuximab.
Safety and tolerability
The most common treatment‑emergent adverse events were fatigue (57.8%) and low‑grade gastrointestinal events such as nausea (67.9%) and vomiting (36.7%). Hematologic events included anemia (57.8%), neutropenia (57.8%), and decreased platelet count and thrombocytopenia (34.9% each). Serious adverse events were reported in approximately one‑third of participants, and treatment discontinuation due to TEAEs occurred in 5.5%. No safety signals for ocular toxicity, peripheral neuropathy, interstitial lung disease, or stomatitis were observed.
Development program
Rina‑S is being evaluated across a broad clinical program that includes four Phase 3 trials in platinum‑resistant ovarian cancer (RAINFOL‑02), recurrent/progressive endometrial cancer (RAINFOL‑03), platinum‑sensitive ovarian cancer maintenance (RAINFOL‑04) and second‑line PSOC (RAINFOL‑07), plus additional studies in NSCLC and advanced gastrointestinal cancers.
Source: Genmab