WASHINGTON (dpa-AFX) - Genmab A/S (GMAB) released updated results from cohort B2 of its Phase 1/2 RAINFOL-01 clinical trial, evaluating rinatabart sesutecan (Rina-S), an investigational antibody-drug conjugate (ADC) targeting folate receptor alpha (FR?) and delivering a TOPO1 inhibitor payload. The data, presented at the European Society for Medical Oncology (ESMO) Congress in Berlin, highlight promising efficacy in heavily pretreated patients with advanced endometrial cancer (EC).
At a median follow-up of one year, patients receiving Rina-S at 100 mg/m² every three weeks (Q3W) achieved a confirmed objective response rate (ORR) of 50.0%, including two complete responses (CR). Notably, 63.6% of responders-including those with CRs-maintained their responses and remained on treatment at the one-year mark. These clinical benefits were observed regardless of FR? expression levels, suggesting broad potential for Rina-S across diverse patient profiles.
Genmab continues to evaluate Rina-S as a single agent in advanced EC through its ongoing Phase 2 RAINFOL-01 and Phase 3 RAINFOL-03 trials.
In recognition of its potential, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Rina-S for the treatment of adult patients with recurrent or progressive EC who have progressed following prior platinum-based chemotherapy and PD-(L)1 therapy.
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