FDA Approves Loncastuximab Tesirine-lpyl for Large B Cell Lymphoma

By Cassie Homer

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The FDA granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, according to a press release

Loncastuximab tesirine-lpyl is a CD-19--directed antibody and alkylating agent conjugate. 

The FDA based the approval on the LOTIS-2 study, an open-label, single arm trial of 145 patients with rr/r DLBCL or high-grade B cell lymphoma, who had at least two prior systemic regimens. 

The dosing schedule consisted of 0.15 mg/kg every 3 weeks for 2 cycles followed by 0.075 mg/kg every 3 weeks for subsequent cycles. Treatment continued until progressive disease or unacceptable toxicity. 

Overall response rate by an independent review committee served as the primary endpoint. 

After a median follow-up of 7.3 months, researchers reported an ORR of 48.3% (95% CI, 39.9-56.7) and a complete response rate of 24.1% (95% CI, 17.4-31.9). Median duration of response was 10.3 months. 

The most common adverse events included including laboratory abnormalities, are thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

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