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.
