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Genmab Announces New Data From Cohort B2 Of Phase 1/2 RAINFOL-01 Trial Evaluating Rina-S, TOPO1-Inhibitor Antibody-Drug Conjugate

Benzinga·06/02/2025 18:32:54
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  • New data showed that rinatabart sesutecan (Rina-S®) 100 mg/m2 led to a confirmed objective response rate (ORR) of 50.0 percent, including two complete responses (CR), and median duration of response (mDOR) was not reached after a median follow-up of 7.7 months
  • Continued evaluation of single-agent Rina-S 100 mg/m2 in patients with advanced endometrial cancer (EC) is ongoing in the Phase 2 RAINFOL™-01 trial and will be further evaluated in a planned Phase 3 trial

Genmab A/S (NASDAQ:GMAB) announced today new data from cohort B2 of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha(FRα)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC). The study showed that with a median on-study follow-up of 7.7 months, treatment with Rina-S 100 mg/m2 every 3 weeks (Q3W) resulted in a 50.0 percent confirmed objective response rate (ORR), including two complete responses (CR), in heavily pre-treated advanced endometrial cancer (EC) patients who experienced disease progression on or after treatment with platinum-based chemotherapy and an immune checkpoint inhibitor. The median duration of response (mDOR) was not reached. These data are from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part RAINFOL-01 trial evaluating the safety and efficacy of Rina-S in solid tumors and were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.