Diffuse Large B-Cell Lymphoma

The study established 4 cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) alone as the new standard approach for the majority of patients with limited-stage diffuse large B-cell lymphoma.

Results from the phase 1/2 ALEXANDER study found the investigational CAR T-cell product AUTO3 in combination with pembrolizumab to have a tolerable safety profile and elicit durable complete responses in patients with relapsed/refractory diffuse large B-cell lymphoma.

The submission is based on results from the phase 2 LOTIS 2 clinical trial, which is evaluating the efficacy and safety of loncastuximab tesirine in patients with relapsed or refractory DLBCL following at least 2 lines of prior systemic therapy.