ADC Therapeutics (ADCT) Announces Updated LOTIS-2 Results Demonstrating Durable, Long-Term Responses of ZYNLONTA in R/R DLBCL
ADC Therapeutics SA (ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data are being presented in a poster today at the European Hematology Association 2023 Hybrid Congress (EHA2023) and will also be featured in an oral presentation at the 17th International Conference on Malignant Lymphoma (17-ICML) being held in Lugano, Switzerland from June 13-17, 2023.
“We’re pleased to be sharing updated LOTIS-2 results demonstrating the long‐term efficacy and safety of ZYNLONTA with the lymphoma community at EHA2023 and 17-ICML,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “Importantly, 31% of patients who achieved a complete response remained event-free for two or more years and did not need new anticancer therapy, which we believe validates the durability of ZYNLONTA in heavily pretreated patients with diffuse large B-cell lymphoma.”
The multicenter, open‐label, single‐arm Phase 2 LOTIS-2 study that evaluated ZYNLONTA in patients with relapsed or refractory DLBCL after ≥2 prior systemic therapies resulted in an overall response rate (ORR) of 48.3% (70/145), with a complete response (CR) rate of 24.8% (36/145). The median (range) time to response was 41.0 (35 to 247) days for all responders and 42.0 (36 to 247) days for patients with a CR. All-grade treatment‐emergent adverse events occurring in ≥30% of all patients were increased gamma-glutamyltransferase (42%), neutropenia (40%), and thrombocytopenia (33%).
Key data from 145 evaluable patients as of the data cutoff of September 15, 2022 include the following:
- The median duration of response (mDOR) was not reached for patients with a CR and was 13.37 months among all responding patients
- Of the 36 patients with a CR, 11 (31%) were event-free for ≥2 years with no evidence of disease and no new anticancer therapy
- In the subsets of patients who were event-free for ≥1 year and ≥2 years, the median (range) duration of time patients remained treatment-free post-ZYNLONTA was 24.8 (3.4 to 37.5) months and 27.7 (20.7 to 37.5) months, respectively
- No new safety signals were identified
“The updated results of the LOTIS-2 study demonstrate significant clinical benefit for patients…
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