ADC Therapeutics Takes Significant Steps Forward with ZYNLONTA® in Japan

ADC Therapeutics Advances ZYNLONTA® in Japan

ADC Therapeutics SA, known for its pioneering work in the field of antibody-drug conjugates (ADCs), recently announced a significant development regarding its product, ZYNLONTA® (loncastuximab tesirine-lpyl), in Japan. On October 29, 2026, Tanabe Pharma Corporation, ADC Therapeutics' licensing partner in Japan, submitted a marketing authorization application to the Ministry of Health, Labor and Welfare for ZYNLONTA, aimed at treating patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Positive Clinical Trial Results

The application is based on encouraging results from the Phase 1/2 MT-2111-A-101 bridging study, which evaluated ZYNLONTA monotherapy in Japanese patients with relapsed or refractory DLBCL. Notably, at the recent Japanese Society of Hematology meeting, it was revealed that in the Phase 2 portion of the study, ZYNLONTA achieved an overall response rate of 58.1%, along with a complete response rate of 41.9%. The median duration of response has not yet been reached, with a median follow-up of over 15 months, indicating the treatment's potential efficacy.

These results mirror the findings from the pivotal LOTIS-2 global study, demonstrating a consistent safety profile without new concerns emerging, which is a critical factor in securing regulatory approval. This data provides a solid foundation for Tanabe Pharma's marketing authorization application, hoping to expand ZYNLONTA's reach in Japan.

Strengthening Partnerships

To bolster its market entry, Tanabe Pharma has also entered into an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd. This collaboration aims to leverage Nippon Shinyaku’s established expertise and commercial capabilities in oncology to support ZYNLONTA’s introduction and promotion in Japan. Nippon Shinyaku has a proven track record of successfully launching pioneering therapies developed by global pharmaceutical companies, making them a valuable partner in this endeavor.

Looking Ahead

Ameet Mallik, CEO of ADC Therapeutics, remarked, “This is a significant step forward in our efforts to expand ZYNLONTA’s global reach to bring this important treatment option to more patients with B-cell malignancies.” The market in Japan is seen as a substantial opportunity for ZYNLONTA, and both ADC Therapeutics and Tanabe Pharma are optimistic about the progress being made and the next steps toward regulatory and commercial milestones.

Under the existing agreement with Tanabe Pharma established in 2022, ADC Therapeutics is focusing on enhancing ZYNLONTA's presence not only in Japan but globally. The upcoming milestones include the acceptance of the marketing application and the initial commercial sale of ZYNLONTA for DLBCL treatment in Japan, which showcases the ongoing commitment of ADC Therapeutics to innovate in the medicines they provide.

With continued advancements and positive feedback from recent studies, ZYNLONTA is on a promising path towards becoming a key therapeutic option for patients battling DLBCL in Japan and beyond. The journey of ZYNLONTA continues as ADC Therapeutics leverages its partnerships and the encouraging results of its clinical trials to make a meaningful impact in the oncology landscape.