Lilly(US:LLY) Prnewswire·2026-01-20 12:45Core Viewpoint - Eli Lilly and Company has received Breakthrough Therapy designation from the FDA for sofetabart mipitecan (LY4170156), aimed at treating adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received bevacizumab and mirvetuximab soravtansine [1][3]. Group 1: Drug Development and Clinical Trials - The Breakthrough Therapy designation is intended to expedite the development and review of drugs that show substantial improvement over existing therapies for serious conditions [2]. - Sofetabart mipitecan is a novel folate receptor alpha (FR) antibody-drug conjugate (ADC) designed to target FR across all expression levels, utilizing proprietary linker technology and an exatecan payload [1][6]. - Initial Phase 1 results presented at the 2025 ASCO Annual Meeting and updated at the 2025 ESMO Congress indicated responses at all dose levels and across all FR expression levels, with a promising tolerability profile [3][4]. Group 2: Market Context and Unmet Needs - Platinum-resistant ovarian cancer is a challenging area in gynecologic oncology, with limited treatment options and poor patient outcomes, highlighting the significant unmet need for effective therapies [3][5]. - Approximately 70% of patients initially responding to platinum-based chemotherapy will experience recurrence, leading to shorter remission periods with each subsequent treatment [5]. Group 3: Ongoing Studies and Collaborations - The Phase 3 FRAmework-01 study is currently underway, investigating sofetabart mipitecan as a monotherapy and in combination with bevacizumab for patients with platinum-resistant and platinum-sensitive ovarian cancer [4]. - Lilly is collaborating with various organizations, including the European Network for Gynaecological Oncological Trial groups and the GOG Foundation, to conduct the FRAmework-01 study [4].