Michael R. Bishop, MD, highlighted the population of patients with relapsed/refractory B-cell non-Hodgkin lymphoma who were enrolled on the phase 3 BELINDA study and treated with tisagenlecleucel.
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 the patient population of focus in the phase 3 BELINDA study (NCT03570892).
BELINDA recruited patients with confirmed relapsed/refractory aggressive non-Hodgkin lymphoma who were within 12 months of first-line chemoimmunotherapy. Tisagenlecleucel (tisa-cel; Kymriah) was administered to patients and compared with standard of care in the second-line setting.
The difficulty here is if you take all patients with [relapsed/refractory aggressive B-cell lymphomas] who are receiving second-line therapy, their response is less than 45%. That means greater than 50% would be ineligible for autologous stem cell transplantation. You take the subset of patients who are primary refractory—that means they would get R-CHOP[rituximab (Rituxan), cyclophosphamide, doxorubicin, vincristine sulfate, and prednisone], go through 6 cycles [of treatment], and their disease was not in complete remission at the end of therapy—that would be considered primary refractory. Then we have these other patients who relapse very shortly thereafter. If you look at their outcomes, they have a very low response rate to second-line therapy generally on the order of about 30% to 40% at best. When they’re taken to autologous stem cell transplantation, even if they have chemotherapy-sensitive disease, the outcomes are not very good. This was the patient population that we targeted in the BELINDA trial where the patients had primary refractory disease or relapsed within 12 months of initial frontline therapy.
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