Dr Phillips on the Rationale for the GLOBRYTE Trial in Relapsed/Refractory MCL

Tycel Phillips, MD, associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, discusses the rationale for launching the phase 3 GLOBRYTE trial (GO43878; EU CT: 2023-503206-37-00) evaluating glofitamab-gxbm (Columvi) monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL), highlighting ongoing enrollment efforts.

Treatment options are limited for patients with relapsed/refractory MCL, particularly those who have experienced progression on a previous BTK inhibitor, Phillips begins. Currently available options include CAR T-cell therapy, such as brexucabtagene autoleucel (brexu-cel; Tecartus), and the non-covalent BTK inhibitor pirtobrutinib (Jaypirca), he explains. Although CAR T-cell therapy is recognized for its effectiveness, its use is limited to certain treatment centers. Moreover, this drug class is associated with high costs and toxicities, making it less suitable for all patients, Phillips emphasizes. Long-term data for pirtobrutinib do not strongly support its durability in relapsed/refractory MCL, especially for patients who progressed on a BTK inhibitor, he adds.

A small phase 1/2 study (NCT03075696) evaluating the use of glofitamab monotherapy in a post-BTK inhibitor setting showed that the agent produced high overall response rates and durable responses, Phillips expands. Based on these data, the phase 3 GLOBRYTE trial was designed to investigate glofitamab for this patient population, he states.

The ongoing trial will be open in multiple countries across approximately 80 sites globally, including the United States, Canada, the United Kingdom, France, Spain, Brazil, Australia, Taiwan, South Korea, Italy, and Sweden in addition to China, he continues. The goal is to enroll a total of 182 patients, Phillips notes, adding that investigators are aiming for rapid accrual and an early readout, Phillips notes. Overall, glofitamab has shown promising efficacy for patients with relapsed/refractory MCL, and its viability as a therapeutic option in this population may be further substantiated in this phase 3 study, he concludes.