Genmab Receives FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S®) in Advanced Endometrial Cancer (EC)

Core Perspective - Genmab A/S announced that the U.S. FDA has granted Breakthrough Therapy Designation to rinatabart sesutecan (Rina-S) for treating adult patients with recurrent or progressive endometrial cancer who have experienced disease progression after prior treatments [2][7] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform the lives of patients with cancer and other serious diseases by 2030 [10][11] Product Development - Rina-S is an investigational antibody-drug conjugate targeting folate receptor alpha (FRα) and is currently undergoing late-stage development, including ongoing Phase 1/2 and Phase 3 trials for various cancers [4][8] - The Breakthrough Therapy Designation is supported by results from the Phase 1/2 RAINFOL™-01 trial, which showed encouraging responses in heavily pretreated endometrial cancer patients [3][7] Clinical Trial Insights - The RAINFOL™-01 trial is an open-label, multicenter study designed to evaluate the safety and efficacy of Rina-S in solid tumors expressing FRα, with multiple cohorts focusing on different cancer types [5][8] - The trial's B2 cohort included 64 patients with advanced or recurrent endometrial cancer who had progressed after anti-PD-(L)1 and platinum-based chemotherapy [3][6] Market Context - Endometrial cancer is the second most prevalent gynecologic cancer globally, with increasing incidence and limited treatment options for advanced cases, highlighting the need for innovative therapies like Rina-S [6][8]