• Wednesday, May 12, 2021 @ 12:00 am

  • Recent FDA approval of ZYNLONTA™ (loncastuximab tesirine-lpyl) was based on data from LOTIS-2
  • ZYNLONTATM demonstrated substantial single-agent activity, durable responses and an acceptable safety profile in broad population of difficult-to-treat patients with relapsed or refractory DLBCL

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, today announced that results of LOTIS-2, a multicenter, open-label, single-arm Phase 2 clinical trial evaluating the safety and efficacy of single-agent ZYNLONTATM in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following two or more systemic treatments, have been published online in The Lancet Oncology.

“Patients with relapsed or refractory DLBCL who have been heavily pretreated and have difficult-to-treat disease represent an urgent area of medical need that newly approved ZYNLONTA is now able to address,” said Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University and lead author of The Lancet Oncology paper. “The LOTIS-2 study established that ZYNLONTA demonstrated substantial single-agent activity and produced durable responses with an acceptable safety profile in this patient population.”

LOTIS-2 enrolled 145 patients, including those with high-risk characteristics for poor prognosis, such as double-/triple-hit, transformed, and primary refractory DLBCL. Key results include:

  • Overall response rate (ORR) was 48.3% (70/145 patients), including a 24.1% (35/145 patients) complete response rate and 24.1% (35/145 patients) partial response (PR) rate
  • Median time to first response, analyzed post-hoc, was 41 days
  • Median duration of response was 10.3 months (as of the data cut)
  • Durable responses in high-risk patient groups included 46.2% (6/13 patients) ORR in those who had progression after prior CAR-T therapy, 33.3% (5/15 patients) ORR in double or triple hit and 44.8% (13/29 patients) ORR in transformed DLBCL
  • ZYNLONTA demonstrated an acceptable safety profile. The most common Grade ≥3 treatment-emergent adverse events were neutropenia (25.5%), thrombocytopenia (17.9%), and increased gamma-glutamyltransferase (16.6%)

“We are proud to have the results of our LOTIS-2 trial published in a prestigious peer-reviewed journal,” said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer at ADC Therapeutics. “On the heels of the FDA approval, this further reinforces the value of ZYNLONTA as the first CD19-targeted ADC single-agent treatment for relapsed or refractory DLBCL and the potential for it to become the standard-of-care for 3L+ DLBCL patients in need of new treatment options.”