Dr. Caimi on the FDA Approval of Loncastuximab Tesirine in R/R Large B-Cell Lymphoma

Paolo F. Caimi, MD, associate professor, Department of Medicine, Division of Hematology and Oncology, School of Medicine, member, Immune Oncology Program, Case Comprehensive Cancer Center, medical director, Clinical Trials Unit, University Hospitals Seidman Cancer Center, physician, Department of Hematology and Oncology, University Hospitals Cleveland Medical Center, discusses the FDA approval of loncastuximab tesirine-lpyl (Zynlonta) in relapsed/refractory large B-cell lymphoma (LBCL).

On April 23, 2021, the FDA granted an accelerated approval to loncastuximab tesirine for the treatment of patients with relapsed/refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, following 2 or more lines of systemic therapy.

The regulatory decision was based on findings from the phase 2 LOTIS-2 trial (NCT03589469), in which loncastuximab tesirine elicited a 48.3% objective response rate, including a 24.1% complete response rate, in this patient population.

Loncastuximab tesirine is a CD19-directed antibody and alkylating agent conjugate that carries a chemotherapy warhead, Caimi says. The approval of the agent offers a single-agent, off-the-shelf option that is not associated with neuropathy for patients with relapsed/refractory LBCL, Caimi explains. Moreover, this patient population benefits from having multiple agents available that target the same antigen, such as CD19, in different modalities, Caimi concludes.