The FDA has granted loncastuximab tesirine-lpyl accelerated approval for large B-cell lymphoma

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August 2021: The FDA granted loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, accelerated approval for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, and DLBCL arising from low grade

LOTIS-2 (NCT03589469), an open-label, single-arm trial in 145 adult patients with relapsed or refractory DLBCL or high-grade B-cell lymphoma after at least two prior systemic treatments, was used to support the approval. Patients were given 0.15 mg/kg loncastuximab tesirine-lpyl every three weeks for two cycles, then 0.075 mg/kg every three weeks for the remaining cycles. Patients were treated until their condition progressed or their toxicity became intolerable.

The overall response rate (ORR) was the primary effectiveness outcome measure, as determined by an independent review committee using Lugano 2014 criteria. With a complete response rate of 24.1 percent, the ORR was 48.3 percent (95 percent CI: 39.9, 56.7). (95 percent CI: 17.4, 31.9). The median response time was 10.3 months after a median follow-up of 7.3 months (95 percent CI: 6.9, NE). Sixty-six percent of the 70 patients who received objective responses were censored for response duration before three months.

Thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anaemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edoema, nausea, and musculoskeletal pain are the most common (20%) adverse reactions in patients receiving loncastuximab tesirine-lpyl, including laboratory abnormalities.

Adverse responses such as edoema and effusions, myelosuppression, infections, and skin reactions are all included in the prescribing material.

The recommended loncastuximab tesirine-lpyl dosage is 0.15 mg/kg every 3 weeks for the first two cycles, then 0.075 mg/kg every 3 weeks for the remaining cycles, given as an intravenous infusion over 30 minutes on the first day of each cycle (every 3 weeks). Dexamethasone 4 mg orally or intravenously twice day for 3 days, starting the day before loncastuximab tesirine-lpyl, should be given to patients.

 

Reference : https://www.fda.gov/

 

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