Benzinga | Jun 18, 2021 07:16AM EDT

ADC Therapeutics Highlights Presentation Of Updated ZYNLONTA Clinical Data At 16th Annual International Conference On Malignant Lymphoma

LOTIS-2 updated results demonstrate durable responses of ZYNLONTA(tm) with median duration of response of 13.4 months in heavily pre-treated patients with relapsed or refractory DLBCL

LOTIS-3 updated Phase 1 data highlight potential of ZYNLONTA(tm) in combination with ibrutinib in relapsed or refractory DLBCL and MCL patients

LOTIS-5 and LOTIS-6 trials evaluating ZYNLONTA(tm) in combination with rituximab in DLBCL patients and as a single agent in FL patients also presented

ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, announced today that posters on four ZYNLONTA(tm) (loncastuximab tesirine-lpyl) clinical trials were presented at the 16th Annual International Conference on Malignant Lymphoma (ICML).

"The updated results from our pivotal LOTIS-2 clinical trial presented at ICML continue to reinforce the efficacy across difficult-to-treat subgroups and sustained duration of response of commercially-available ZYNLONTA as a single agent for patients with relapsed or refractory diffuse large B-cell lymphoma," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We're also pleased that the updated data from the LOTIS-3 clinical trial demonstrate the encouraging antitumor activity and manageable toxicity profile of ZYNLONTA in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma. We look forward to continued progress in all of our LOTIS trials, including the ongoing LOTIS-5 trial of ZYNLONTA in combination with rituximab and LOTIS-6 trial in patients with relapsed or refractory follicular lymphoma."

LOTIS-2 Follow-up Analysis (Poster 177)

In LOTIS-2, a single-arm, open-label, 145-patient Phase 2 clinical trial in patients with relapsed or refractory DLBCL who had failed ?2 established therapies, ZYNLONTA demonstrated continued substantial antitumor activity and an acceptable safety profile. Updated results were presented in a poster by Pier Luigi Zinzani, MD, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Ser?gnoli", and Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Universit? di Bologna, Bologna, Italy. As of the data cut-off date of March 1, 2021, all patients had completed treatment.

Key data include:

* Overall response rate (ORR) was 48.3% and complete response rate (CRR) was 24.8%

* Median duration of response (mDoR) of 13.4 months for the 70 responders

* Median duration of response not reached for patients with a complete response

* Median overall survival was 9.5 months

* No new safety concerns were identified during the study and no increase in toxicity was observed in patients aged ?65 years compared with patients <65 years. The most common grade ?3 treatment-emergent adverse events (TEAEs) were neutropenia (26.2%), thrombocytopenia (17.9%), increased gamma-glutamyltransferase (17.2%), and anemia (10.3%)

LOTIS-3 Updated Phase 1 Results (Poster 238)

LOTIS-3, a Phase 1/2, two-part, open-label, single-arm clinical trial, is evaluating ZYNLONTA in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). Updated Phase 1 results were presented in a poster by Julien Depaus, MD, Department of Hematology, CHU UCL Namur site Godinne, Yvoir, Belgium. As of the data cut-off date of March 1, 2021, 30 patients with DLBCL (24 with non-germinal center B-cell (non-GCB) DLBCL and 6 with GCB DLBCL) and 7 patients with MCL were included in the study.

Key data include:

* ORR in all patients was 62.2% and CRR was 35.1% In non-GCB DLBCL patients, ORR was 66.7% In GCB DLBCL patients, ORR was 16.7% In MCL patients, ORR was 85.7%

* ZYNLONTA in combination with ibrutinib had manageable toxicity, with the most common grade ?3 TEAEs in ?5% of patients being anemia (10.8%), neutropenia (10.8%), thrombocytopenia (5.4%), and fatigue (5.4%)

* Pharmacokinetic profiles demonstrated sustained exposure and modest accumulation by Cycle 2

Two additional posters presented at the 16th Annual ICML

* Phase 3 Randomized Study of Loncastuximab Tesirine plus Rituximab versus Immunochemotherapy in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma - LOTIS-5 (Poster 251)

* A Phase 2 Randomized Study of Loncastuximab Tesirine (Lonca) Versus (Vs) Idelalisib in Patients (Pts) with Relapsed or Refractory (R/R) Follicular Lymphoma (FL) - LOTIS-6 (Poster 264)