The following is a summary of “Safety and efficacy of tafasitamab ± lenalidomide added to first-line R‑CHOP for DLBCL: Phase 1b First-MIND study,’’ published in the June 2023 issue of Hematology by Belada et al.
The combination of tafasitamab and lenalidomide is administered to diffuse large B-cell lymphoma (DLBCL) patients who are ineligible for autologous stem cell transplant.
Researchers performed a cohort study to investigate the safety and initial efficacy of tafasitamab in combination with R-CHOP ± lenalidomide in DLBC patients. Study allocated the newly-diagnosed, untreated DLBCL adults (ECOG PS 0-2, IPI 2-5) to receive either R-CHOP+tafasitamab (Arm T) or R-CHOP+tafasitamab+lenalidomide (Arm T/L) for 6 cycles, setting primary endpoint as safety; secondary endpoints were overall response rate (ORR) and complete response (CR) rate at the end of treatment (EoT).
A total of 83 patients were screened between December 2019 and August 2020, with 66 of them receiving treatment (n=33 per arm). Patients experienced at least 1 treatment-emergent adverse event, mostly grade 1/2. Grade ≥3 neutropenia and thrombocytopenia were observed in 57.6% and 12.1% of patients in (Arm T) and 84.8% and 36.4% in (Arm T/L), respectively. The occurrence of non-hematologic toxicities was similar between the two arms. R-CHOP’s mean relative dose intensity was 89% or higher in both arms.
At the end of treatment, the overall response rate (ORR) was 75.8% (with a complete response rate of 72.7%) in Arm T and 81.8% (with a complete response rate of 66.7%) in Arm T/L. The best ORR observed across visits was 90.0% and 93.9% for Arm T and Arm T/L, respectively. The rates of an 18-month duration of response and duration of complete response were 72.7% and 74.5% in (Arm T) and 78.7% and 86.5% in (Arm T/L). Investigators observed safe signals of efficacy in both arms.
Study concluded the potential advantage of incorporating tafasitamab+lenalidomide into R-CHOP is currently under investigation in phase 3 frontMIND trial (NCT04824092).