ADC Therapeutics disclosed that the updated LOTIS‑7 Phase 1b trial, which enrolled 49 patients with relapsed or refractory diffuse large B‑cell lymphoma, achieved an overall response rate of 89.8 % and a complete response rate of 77.6 % after a minimum of six months of follow‑up. The safety profile remained manageable, with no new safety signals and a lower incidence of cytokine release syndrome and neurotoxicity compared with glofitamab monotherapy; neutropenia was the most common Grade 3/4 adverse event.
The new data build on the May 2025 interim results, which reported a 95.5 % ORR and 90.9 % CR in 22 patients. While the current ORR and CR rates are slightly lower, the larger cohort and longer follow‑up reinforce the durability of responses—33 of 38 patients who achieved CR remain in remission. This consistency strengthens confidence in the combination’s therapeutic potential.
Safety remains a key focus for the company. The combination’s CRS and ICANS rates are lower than those seen with glofitamab alone, suggesting a synergistic safety advantage. The most frequent Grade 3/4 event, neutropenia, was manageable with standard supportive care, underscoring the tolerability of the regimen in a heavily pre‑treated population.
Strategically, the ZYNLONTA‑plus‑glofitamab combination is positioned to become a best‑in‑class therapy for second‑line and beyond r/r DLBCL. By demonstrating superior efficacy and a favorable safety profile, the data support an earlier‑line expansion of ZYNLONTA and could shift the competitive landscape away from other bispecifics and CAR‑T products.
Enrollment of the full 100‑patient cohort is expected to be completed in the first half of 2026, with full data slated for presentation at a major medical congress and publication by the end of 2026. These milestones set the stage for regulatory submissions in 2027, potentially accelerating market entry and revenue generation.
Investors reacted cautiously, citing concerns about the safety profile and the time required to complete enrollment and regulatory review. CEO Ameet Mallik emphasized the company’s confidence in the data, stating that the results “further strengthen the evidence supporting the differentiated profile of the combination.” Chief Medical Officer Mohamed Zaki highlighted the manageable safety profile and the durability of responses, reinforcing the company’s belief that the combination could become a leading option for r/r DLBCL patients.
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