Genmab A/S announced updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted antibody-drug conjugate (ADC). The study showed that Rina-S 120 mg/m² every 3 weeks resulted in a confirmed objective response rate (ORR) of 55.6% in heavily pre-treated ovarian cancer patients, regardless of FRα expression levels.
With a median on-study follow-up of 48 weeks, only 1 out of 10 patients experienced disease progression, and the median duration of response (mDOR) was not reached. Complete responses were observed in 4 patients, with 2 confirmed and 2 unconfirmed, and 8 patients experienced confirmed partial responses.
Rina-S 120 mg/m² has been selected for further evaluation in the RAINFOL-01 and Phase 3 RAINFOL-02 trials for platinum-resistant ovarian cancer. In January 2024, the U.S. Food and Drug Administration granted Fast Track designation to Rina-S for FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer, aiming to expedite its development.
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