The CD19-targeted antibody drug conjugate (ADC) was granted accelerated approval by the US regulator based on overall response rate.
The approval also covers patients with DLBCL arising from low grade lymphoma and high-grade B-cell lymphoma.
“This is the first ever approval of a PBD based ADC,” noted Chris Martin, CEO, ADC Therapeutics, on a conference call about the regulatory development and commercial launch.
The Lausanne, Switzerland based biotech is now entering “the next phase of transformation and growth,” he added.
Response rate
Dr Paolo F Caimi, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University, said there is a significant unmet need for treatment options for patients with r/r DLBCL, including those who have been heavily pretreated and have difficult-to-treat disease.
“Single-agent ZYNLONTA (loncastuximab tesirine-lpyl) demonstrated clinically important outcomes in the pivotal LOTIS-2 study across several disease subtypes. Notably, this included transplant eligible and ineligible patients and patients who previously received stem cell transplant or CAR-T cell therapy.”
Results from the LOTIS-2 trial demonstrated an overall response rate (ORR) of 48.3% – 70 out of 145 patients, which included a complete response (CR) rate of 24.1% – 35 out of 145 patients, and a partial response (PR) rate of 24.1% – 35 out of 145 patients.
Patients had a median time to response of 1.3 months and the median duration of response for the 70 responders was 10.3 months.