ADC Therapeutics' Japan Partner Files Marketing Application for ZYNLONTA in Relapsed/Refractory DLBCL

ADC Therapeutics SA (ADCT) said its Japanese licensing partner, Tanabe Pharma Corporation, filed a marketing authorization application with Japan's Ministry of Health, Labour and Welfare for ZYNLONTA (loncastuximab tesirine-lpyl) to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The filing is supported by the Japanese Phase 2 portion of the Phase 1/2 MT-2111-A-101 bridging study, which showed an overall response rate of 58.1%, including a complete response rate of 41.9%. Median duration of response had not been reached at a median follow-up of 15.21 months. Results were consistent with the global Phase 2 LOTIS-2 study, with no new safety concerns identified. Tanabe Pharma also entered an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd. for commercialization of ZYNLONTA in Japan, while retaining responsibility for development and regulatory approval. Near-term milestones for ADC Therapeutics include application acceptance and first commercial sale. ADCT traded at $1.51, down 6.79%.