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FDA Accelerated Approval for Relapsed/Refractory Large B-Cell Lymphoma
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.
LOTIS-2 Trial Data: Response Rates and Duration
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.
Adverse Reactions and Dosage Protocol
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.
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About Susan Hau
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy. Hau's expertise lies in cancer cell biolo…
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