Genmab(US:GMAB) GlobeNewswire·2025-06-02 18:30Core Insights - Genmab A/S announced promising results from the Phase 1/2 RAINFOL™-01 trial for rinatabart sesutecan (Rina-S), showing a 50.0% confirmed objective response rate (ORR) in advanced endometrial cancer patients [2][3][6] - The study involved 64 heavily pre-treated patients, with a median follow-up of 7.7 months, and demonstrated significant anti-tumor activity [3][4] - Rina-S is an investigational antibody-drug conjugate targeting folate receptor alpha (FRα), with ongoing evaluations in various cancers [10][11] Company Overview - Genmab is focused on developing innovative antibody-based medicines to address unmet needs in cancer treatment, particularly for gynecologic cancers [5][12] - The company has a robust pipeline, including bispecific T-cell engagers and antibody-drug conjugates, aiming to transform cancer treatment by 2030 [12] Clinical Trial Details - The RAINFOL-01 trial is an open-label, multicenter study evaluating Rina-S in solid tumors, with specific cohorts for endometrial cancer [6][7] - The B2 cohort results indicate that Rina-S 100 mg/m led to a 50.0% ORR, while the 120 mg/m cohort showed a 47.1% ORR, with no median duration of response reached [3][4][6] Treatment Context - Advanced endometrial cancer has limited treatment options after progression on standard therapies, highlighting the need for new therapies like Rina-S [8][9] - The incidence and mortality rates of endometrial cancer are increasing, emphasizing the urgency for effective management strategies [8] Safety Profile - Common treatment emergent adverse events included diarrhea, dyspnea, and urinary tract infections, with serious adverse events occurring in 31.8% and 50.0% of patients in the 100 mg/m and 120 mg/m cohorts, respectively [4][5] - No significant ocular toxicities or interstitial lung disease were observed, which are often concerns with antibody-drug conjugates [4]