Their Phase I clinical trial was a success. Today, the Vaud based ADC Therapeutics has dosed the first patient with relapsed or refractory diffuse large B-Cell Lymphoma in its phase II clinical trial of ADCT-402.
Last year, ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs) raised $200 million to accelerate the development of its pipeline products, including ADCT-402, a new therapy for treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The first clinical trials were conducted with 138 evaluable, heavily pre-treated lymphoma patients who had failed, or were intolerant to any established therapy known to provide clinical benefit with a median of three prior therapies. At the time, for the 49 response-evaluable patients in Part 1 of the study (dose escalation) with DLBCL who received ADCT-402 at doses greater than or equal to 120 μg/kg, the overall response rate (ORR) was 55 percent (27/49), with 18 patients achieving a complete response (37 percent) and 9 patients achieving a partial response (18 percent).
Today, the company has dosed the first patient in its Phase II clinical trial intended to support the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The clinical trial is evaluating the efficacy and safety of ADCT-402 (loncastuximab tesirine) in patients.
The primary endpoint of the Phase II, multi-center, open-label, single-arm trial is the ORR in patients treated with ADCT-402, as confirmed by central review. Secondary endpoints include assessments of duration of response, complete response rate, relapse-free survival, progression-free survival and overall survival, as well as safety, pharmacokinetics and health-related quality of life. The trial will enroll approximately 140 patients with relapsed or refractory DLBCL at multiple centers in the USA and Europe.
“There is currently no effective treatment for patients with multiple relapsed and refractory DLBCL, so we are excited about the potential to improve outcomes in these patients with ADCT-402 in a single-arm trial”, said Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics.
Alex Spira, Director of Virginia Cancer Specialists Research Institute and Clinical Assistant Professor of Oncology at Johns Hopkins School of Medicine, added, “Patients with DLBCL who have relapsed or are refractory after second-line chemotherapy face a very poor prognosis. There is a significant unmet need for an effective new treatment option for this patient population, and we believe ADCT-402 has the potential to help impact patient outcomes in this disease.”
(Press release/ran)
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