REG-Genmab Announces Rinatabart Sesutecan (Rina-S®) Phase 2 RAINFOL™-01 Results Demonstrated Durable and Clinically Meaningful Responses in Patients with Platinum-Resistant Ovarian Cancer
Genmab reported Part C results from the Phase 1/2 RAINFOL-01 trial showing Rina-S achieved a 45.9% confirmed ORR and 12.1-month median duration of response in 109 patients with platinum-resistant ovarian cancer. Median PFS was 9.5 months — the first PFS data for the program — and antitumor activity was observed regardless of FRα expression level, broadening the potential addressable population. Safety was manageable, with 5.5% discontinuation due to adverse events and no signals for ocular toxicity, neuropathy, ILD, or stomatitis.
Key figures
- Drug Name
- Rinatabart Sesutecan (Rina-S; GEN1184)
- Phase Of Trial
- Phase 1/2 (RAINFOL-01, Part C)
- Orr
- 45.9%
- Dose
- 120 mg/m2 Q3W
- Orr ci
- 95% CI: 36.3-55.7
- Mdor months
- 12.1
- Mpfs months
- 9.5
- Patients treated
- 109
- Complete responses
- 5
- Phase3 trials ongoing
- 4
- Discontinuation due to teae
- 5.5%
- Responders in response at 1yr
- 51%
AI analysis
Red flags2 · Pro
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.