The FDA gave accelerated approved to loncastuximab tesirine-lpyl (Zynlonta) as a third-line therapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Loncastuximab tesirine-lpyl, a CD19-directed antibody and alkylating agent conjugate, takes the form of an intravenous infusion given over 30 minutes once every three weeks. Due to the accelerated approval, the FDA noted that continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.
This approval was based on results from the phase III multinational, single-arm LOTIS-2 trial, the drug’s manufacturer, ADC Therapeutics, explained in a company press release. The trial recruited 145 patients with relapsed/refractory DLBCL who had taken two or more prior lines of systemic therapy.
“Results from the trial demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients),” the company explained. “Patients had a median time to response of 1.3 months and the median duration of response (mDoR) for the 70 responders was 10.3 months (inclusive of patients who were censored).”
The manufacturer added that, according to findings from a pooled safety population, the most common side effects associated with the drug conjugate included thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. The most common grade 3 or greater treatment-emergent adverse events reported in LOTIS-2 were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%), and anemia (10.3%).
The FDA also warned that health care professionals should monitor patients on loncastuximab tesirine-lpyl for pleural effusion, pericardial effusion, ascites, peripheral edema, and general edema. In addition, patients should be monitored for myelosuppression, infections, and new or worsening cutaneous reactions, including photosensitivity reactions.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 467
Topic ID: 78,467,730,467,192,925
