Michael R. Bishop, MD, Discusses Impact of Tisa-Cel on B-Cell NHL From BELINDA Trial

Michael R. Bishop, MD, professor of medicine and director of the David and Etta Jonas Center for Cellular Therapy, University of Chicago, spoke with CancerNetwork® at the 2021 American Society of Hematology Annual Meeting about how the results of the phase 3 BELINDA trial (NCT03570892) can play a role in shaping research moving forward.

Although no significant difference in efficacy was observed between tisagenlecleucel (tisa-cel; Kymriah) and standard of care for patients with relapsed or refractory aggressive non-Hodgkin lymphoma, Bishop detailed ways in which the results from BELINDA can impact future research in this area.

Transcript:

[BELINDA] verified prior results about this unique patient population. This patient population hasn’t been studied prospectively, and the data show that this is a very aggressive histology. What’s interesting is there were many patients who had primary refractory disease who eventually received tisa-cel as part of the JULIET trial (NCT02445248). Those patients are different than who we were treating in the sense that some of them may have eventually gone out, but there is a certain proportion of patients whose disease is aggressive and the biology is significantly different; we were seeing more of those patients. If they were good enough to eventually get to third- or fourth-line therapy, they may have had [disease that is] a bit different, and we think there is a distinction there.

Our results did demonstrate [data] consistent with what had been reported historically about responsiveness of this patient subset who got randomized to the standard-of-care arm. Again, relatively low [rate of complete responses] in the order of approximately 30% in terms of chemotherapy-sensitivity, which speaks to the fact that this is a different biology and is more aggressive disease. We do hope that some of the factors of how our trial was designed, if verified, [will impact future research]. We believe you need to get the cells in [for CAR T manufacturing] as quick as possible and adequate lymphodepleting chemotherapy. Taking those all together, we hope that it will be applied to future clinical designs.

Reference

Bishop MR, Dickinson M, Purtill D. et al. Tisagenlecleucel vs standard of care as second-line therapy of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma: Analysis of the phase III Belinda study. Blood 2021;138(suppl 2):LBA-6. doi:10.1182/blood-2021-155068