ADC Therapeutics (ADCT) Announces Updated LOTIS-2 Results Demonstrating Durable, Long-Term Responses of ZYNLONTA in R/R DLBCL

ADC Therapeutics SA (NYSE: 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 with recurrent diffuse large B-cell lymphoma, an aggressive subtype of non-Hodgkin lymphoma,” said Mehdi Hamadani, MD, Professor, Medical College of Wisconsin. “I am excited by the potential of ZYNLONTA to treat underserved patients. ZYNLONTA continues to be a welcome option for patients with difficult-to-treat lymphoma and gives hope to them and their families.”

Presentations at 17-ICML

Details of ADC Therapeutics’ oral presentation at 17-ICML are as follows:

Long-Term Responses with Loncastuximab Tesirine: Updated Results From LOTIS-2, the Pivotal Phase 2 Study In Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma [Encore of EHA 2023]
Session: “Focus On...” Session - Large B-Cell And Double Hit Lymphomas
Session Date and Time: Thursday, June 15, 2023, 17:00 – 18:00 CEST // 11:00 am – 12:00 pm EDT
Presentation Time: 17:30 CEST // 11:30 am EDT
Location: Cinema Corso
Presenting Author: Paolo F. Caimi, MD, Cleveland Clinic Taussig Cancer Center, Cleveland, OH, USA

Details of a poster presentation independently driven by IGM Biosciences at 17-ICML are as follows:

Combination of Imvotamab and Loncastuximab Tesirine Shows Enhanced Anti-Tumor Activity in a Preclinical Model of Non-Hodgkin’s Lymphoma
Session: Lugano Poster session
Location: Marquee Parco Ciani
Presenting Author: Kathryn A. Logronio, IGM Biosciences, Inc.

Posters will be available on: Wednesday, June 14, 2023, 12:00 – 18:00 CEST; Thursday, June 15, 2023, 10:00 – 18:00 CEST; and Friday, June 16, 2023, 10:00 – 18:00 CEST. Presenters will be with posters on Thursday, June 15, 2023, from 12:30 – 13:00 CEST. ePosters will be accessible virtually in Gallery from June 14-December 15, 2023.

Titles of ADC Therapeutics’ abstracts accepted for publication only are as follows:

• LOTIS-5, an Ongoing Phase 3 Randomized Study of Loncastuximab Tesirine with Rituximab (Lonca-R) Versus Immunochemotherapy in Patients with R/R DLBCL
• Phase 1b Open-Label Study of Loncastuximab Tesirine in Combination with Other Anticancer Agents in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) [Encore of ASCO 2023]

All accepted abstracts will be included in the Abstract Book, supplement to “Hematological Oncology” (John Wiley and Sons, Inc.), published online on Wiley Online Library on June 9 (23:59 CEST).

You May Also Be Interested In

• Mainz Biomed (MYNZ) Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm
• Kiromic BioPharma (KRBP) Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Trial First Three Patients
• Atlassian (TEAM) comes ahead of Street estimates in Q1 but shares tumble