ADC Therapeutics Reports Enrollment Completion in P-III (LOTIS-5) Study of Zynlonta Plus Rituximab for 2L+ Diffuse Large B-Cell Lymphoma
Shots:
- The patient enrollment in confirmatory P-III (LOTIS-5) study assessing Zynlonta + rituximab for treating 2L+ r/r DLBCL has been completed. Zynlonta was previously approved in 2021 under accelerated pathway for the same
- The study aims to convert accelerated approval & support label expansion to 2L+ with rituximab. Part 1 enrolled 20 patients for a safety run-in, while part 2 randomizes patients 1:1 to Zynlonta with rituximab or R-GemOx
- The 1EP includes PFS while the 2EPs are OS, ORR, CR rate, DoR along with frequency and severity of AEs; topline data is expected by YE’25, with FDA submission in Q1’26 & approval in late 2026. In addition, previous data depicted ORR of 80% ORR & CRR of 50%
Ref: ADC Therapeutics | Image: ADC Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.