Tanabe Pharma announces positive Phase 2 results for ZYNLONTA® (MT-2111) in relapsed/refractory DLBCL, matching global data and paving way for Japan NDA. Learn about the CD19 ADC’s safety and next steps.
Written By: Pharmacally Medical News Desk
Tanabe Pharma Corporation announced positive top-line results from the Phase 2 portion of its Japanese Phase 1/2 trial (MT-2111-A-101; NCT05658562) evaluating MT-2111 (ZYNLONTA®, loncastuximab tesirine-lpyl). This CD19-directed antibody-drug conjugate (ADC) met its primary endpoint of overall response rate (ORR) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
The trial acts as a bridging study to support ADC Therapeutics’ global LOTIS-2 pivotal Phase 2 program. Safety data in Japanese patients aligned with overseas results.
Yosuke Kimura, PhD, Head of Development and Medical Affairs at Tanabe Pharma, stated:
“These encouraging results stem from our R&D efforts and strong partner collaborations. This progress offers new hope to patients and reinforces our mission to create solutions for those facing illness. We remain dedicated to rigorous evaluations and regulatory collaboration to deliver this treatment swiftly.”
ADC Therapeutics CEO Ameet Mallik added: “We congratulate Tanabe Pharma on completing this Japanese study. These data further validate ZYNLONTA®’s strength in DLBCL, bringing us closer to reaching more r/r patients in Japan.”
Regulatory Path and Next Steps in Japan
Tanabe Pharma inked an exclusive license with ADC Therapeutics in January 2022 for ZYNLONTA® development and commercialization in Japan across hematologic and solid tumors.
The company now plans a new drug application (NDA) filing, leveraging MT-2111-A-101 data alongside global results. This advances their oncology expansion to bring innovative therapies to Japanese patients.
ZYNLONTA® earned U.S. FDA accelerated approval in April 2021 as the first CD19-targeted ADC for adults with r/r DLBCL after ≥2 prior systemic therapies. EMA approval followed for similar indications, including:
- DLBCL not otherwise specified
- DLBCL from low-grade lymphoma
- High-grade B-cell lymphoma
Approvals are confirmatory, pending ongoing trials.
About ZYNLONTA® Mechanism
ZYNLONTA® targets CD19 on malignant B-cells. It internalizes, releasing a pyrrolobenzodiazepine (PBD) payload that:
- Binds DNA
- Triggers cell cycle arrest
- Induces tumor cell death
The therapy is also in trials for combination regimens and earlier lines in B-cell malignancies.
References
MT-2111 (loncastuximab tesirine-lpyl) Achieved Primary Endpoint in Phase 2 part of Japanese Phase 1/2 study for Relapsed or Refractory Diffuse Large B-cell Lymphoma, 29 January 2026, January 29, 2026 MT-2111 (loncastuximab tesirine-lpyl) Achieved Primary Endpoint in Phase 2 part of Japanese Phase 1/2 study for Relapsed or Refractory Diffuse Large B-cell Lymphoma
Gefitinib With Anlotinib in Advanced Non-squamous NSCLC Patients with Uncleared Plasma ctDNA EGFRm After First-line Treatment with Gefitinib, ClinicalTrials.gov ID NCT04358562, https://clinicaltrials.gov/study/NCT04358562