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RAINFOL-01 (Rina-S)

A next-generation folate-receptor ADC that works even in tumours with low folate receptor, with responses in both ovarian and endometrial cancer.

Ovarian cohort: confirmed ORR 55.6% at 120 mg/m² (n=20) and 22.7% at 100 mg/m² (n=22) with long follow-up; endometrial cohort (n=64, after anti-PD-1 and platinum): ORR 50% at 100 mg/m² including complete responses, earning Breakthrough Therapy designation. Phase 3 RAINFOL-02 in platinum-resistant ovarian cancer is enrolling, with primary completion expected in 2027. Unlike mirvetuximab, benefit is not restricted to FRα-high tumours.

Setting
Advanced ovarian and endometrial cancer, heavily pretreated: rinatabart sesutecan (FRα ADC, exatecan payload) across FRα expression levels
Phase
Phase 1/2
Sponsor
Genmab
Registry
Headline result
ORR 55.6% (ovarian, 120 mg/m²); 50% (endometrial, 100 mg/m²).
Reported
2025

Outcomes

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In plain words
What these results mean for people, not percentages
Objective response rate, ovarian, 120 mg/m²response endpoint
  • 55.6 out of 100 people had their tumour shrink with Rina-S.
Objective response rate, endometrial, 100 mg/m²response endpoint
  • 50 out of 100 people had their tumour shrink with Rina-S.
Be careful
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
  • These results apply to the people the trial enrolled: Advanced ovarian and endometrial cancer, heavily pretreated: rinatabart sesutecan (FRα ADC, exatecan payload) across FRα expression levels. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

Objective response rate, ovarian, 120 mg/m²
Rina-S55.6 of 100
n = 20
Source
Objective response rate, endometrial, 100 mg/m²
Rina-S50 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Objective response rate, ovarian, 120 mg/m²Rina-S2055.6%link
Objective response rate, endometrial, 100 mg/m²Rina-S50%link

Connected

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