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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