Dr Phillips on the Safety and Efficacy of Glofitamab in Relapsed/Refractory MCL

Tycel Phillips, MD, MPH, associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, discusses updated efficacy and safety data derived from the phase 1/2 NP30179 trial (NCT03075696) evaluating glofitamab-gxbm (Columvi) for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).

Notably, these data were shared at the 2024 ASCO Annual Meeting. In this updated efficacy analysis, investigators reconfirmed the overall response rate (ORR) and complete response (CR) rate that glofitamab derived in a larger patient cohort, Phillps begins. There were 60 total evaluable patients. Consistent efficacy was observed irrespective of prior BTK inhibitor exposure, and the ORR and CR rates were notably high in BTK inhibitor–naive patients, he explains. Data regarding duration of response and progression-free survival (PFS) continue to mature, with a median follow-up of 17 months for CR and 19.6 months (95% CI, 11.9-26.1) for PFS. Phillips says investigators observed a median PFS of 16.8 months (95% CI, 8.9-21.6) in the overall patient population.

In terms of safety, no new safety signals were detected, he continues. However, there were several incidents of COVID-19 fatalities, which was an unfortunate reality during the pandemic, Phillips notes. This was influenced by the integration of new drugs and the evolution of COVID-19, particularly the emergence of the virulent Omicron variant of the SARS-CoV-2 virus in late 2021 and its dominance throughout most of 2022, he elucidates. As investigators continue to explore glofitamab monotherapy in the ongoing phase 3 GLOBRYTE trial (NCT06084936), strategies to mitigate COVID-19 infection are in place, Phillips explains, adding that these mitigation strategies may be increasingly feasible since current SARS-CoV-2 strains appear less virulent than Omicron.