- Rina-S achieved a 50% objective response rate in a Phase 1/2 trial for advanced endometrial cancer.
- The FDA granted Breakthrough Therapy Designation to Rina-S for advanced endometrial cancer.
- Phase 3 trials for Rina-S in endometrial cancer and platinum-resistant ovarian cancer are ongoing.
- Common adverse events include cytopenias and low-grade gastrointestinal issues, with no ocular toxicities observed.
Trial Results
Updated data from the Phase 1/2 RAINFOL™-01 trial showed that Rina-S achieved a 50% confirmed objective response rate in heavily pretreated patients with advanced endometrial cancer. This includes two complete responses, regardless of FRα expression levels. At a median follow-up of one year, 63.6% of responders maintained their responses and remain on treatment.
FDA Designation
The U.S. FDA has granted Breakthrough Therapy Designation to Rina-S for the treatment of advanced endometrial cancer. This designation is for patients who have progressed following platinum-based chemotherapy and an immune checkpoint inhibitor.
Ongoing Trials
Rina-S is being further evaluated in the Phase 2 RAINFOL-01 trial and the Phase 3 RAINFOL-03 trial for endometrial cancer. Additionally, a Phase 3 trial is underway for patients with platinum-resistant ovarian cancer.
Adverse Events
Common treatment-emergent adverse events include cytopenias and low-grade gastrointestinal issues. Serious adverse events occurred in 36.4% of patients treated with 100 mg/m² and 52.4% with 120 mg/m². No ocular toxicities, neuropathy, or interstitial lung disease have been observed.
