FDA approves anti-CD19 treatment for r/r diffuse large B-cell lymphoma
The U.S. Food and Drug Administration (FDA) has approved loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after ≥ 2 lines of systemic therapy, according to a press release.
Approval was based on data from a Phase 2 multinational, single-arm clinical trial evaluating Zynlonta in 145 patients with r/r DLBCL. An overall response rate of 48.4%, complete response rate of 24.1%, and partial response rate of 24.1% was demonstrated with a medial time to response of 1.3 months and a median duration of response of 10.3 months for the responders.
A pooled safety population identified the most common adverse reactions as thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain. In LOTIS-2, the most common grade ≥3 treatment-emergent adverse events were neutropenia, thrombocytopenia, gamma-glutamyltransferase increased, and anemia.
“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,” said Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University in a press release. “Single-agent ZYNLONTA 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.”
Read the full press release here.