Primary End Point Not Met in Trial Testing Nivolumab Monotherapy for DLBCL
Nivolumab monotherapy for R/R DLBCL failed to confer improved objective response rates, but did produce durable responses in 3 individuals.
Patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who were treated with nivolumab monotherapy showed no new safety concerns but had a low response rate, causing the phase 2 trial to miss its primary end point of improved objective response rate (ORR).1 The trial results were published online January 8, 2019, in the Journal of Clinical Oncology.
Patients with R/R DLBCL were recruited for the single-arm, open-label trial and received nivolumab 3 mg/kg monotherapy every 2 weeks. Eligible patients were either ineligible for autologous hematopoietic cell transplantation (auto-HCT) or did not respond to treatment with auto-HCT. Patients were grouped into an auto-HCT–ineligible cohort and auto-HCT–failed cohort.
A total of 121 patients were treated, with 34 in the auto-HCT–ineligible cohort and 87 in the auto-HCT–failed cohort. The auto-HCT–ineligible cohort had a median follow-up of 6 months and the auto-HCT–failed cohort had a median follow-up of 9 months.
The ORR was 3% in the auto-HCT–ineligible cohort and 10% in the auto-HCT–failed cohort. The median duration of response was 8 months in the auto-HCT–ineligible cohort and 11 months in the auto-HCT–failed cohort, with median progression-free survival of 1.4 months and 1.9 months, respectively, and median overall survival of 5.8 months and 12.2 months, respectively.
In the auto-HCT–failed cohort, 3 patients (3%) had complete responses and all were durable, lasting 11 months or longer, 14 months or longer, and 17 months or longer.
Nearly a quarter of patients (24%) reported treatment-related adverse events, with the most common being neutropenia (4%), thrombocytopenia (3%), and increased lipase (3%).
“In conclusion, the results of this phase II study indicate that nivolumab monotherapy has a low response rate but may provide benefit in a small number of patients with DLBCL who have experienced failure with auto-HCT or who are ineligible for auto-HCT and is associated with a favorable safety profile,” the study authors wrote.
- Ansell SM, Minnema MC, Johnson P, et al. Nivolumab for relapsed/refractory diffuse large b-cell lymphoma in patients ineligible for or having failed autologous transplantation: A single-arm, phase II study [published online January 8, 2019]. J Clin Oncol. doi: 10.1200/JCO.18.00766