Future oncology (London, England) · 2025
Nivolumab plus brentuximab vedotin for relapsed/refractory diffuse large B-cell lymphoma.
СтатьяКлиническое исследование II фазыКлиническое исследование I фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Johnson Nathalie A, Zinzani Pier Luigi, Domingo-Domenech Eva, Brody Joshua, Kline Justin, Shah Bijal Dinesh, Mehta Amitkumar Nitinkumar, Ghesquieres Herve, Savage Kerry J, Barr Paul M, Santoro Armando, Ferrari Silvia, Cunningham David, Collins Graham P, Fanale Michelle, Krajewski Jennifer, Akyol Alev, Crowe Russell, Wen Rachael, Kuruvilla John
Аннотация
AIMS: Up to 40% of patients with diffuse large B-cell lymphoma (DLBCL) have relapsed or refractory (R/R) disease after first-line treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone, and outcomes are poor after hematopoietic stem cell transplantation failure. CheckMate 436 (NCT02581631) was a phase 1/2 study to evaluate the efficacy and safety of nivolumab, a PD-1/PD-L1 inhibitor, plus brentuximab vedotin (BV) for the treatment of R/R non-Hodgkin lymphoma.
MATERIALS AND METHODS: Adult patients received nivolumab plus BV in 3-week cycles. The primary endpoint was overall response rate (ORR). Here, we report the results from the R/R DLBCL cohort (n = 42).
RESULTS: With a median follow-up of 7.7 months, the ORR was 28.6% (n = 12), and 7.1% (n = 3) of patients achieved a complete response. Median duration of response (95% CI) was 3.6 (1.2-36.5) months. All patients experienced an adverse event (AE), most commonly diarrhea (n = 20, 47.6%). Grade 3/4 and 5 AEs occurred in 24 (57.1%) and 4 (9.5%) patients, respectively. Any-grade treatment-related AEs occurred in 35 (83.3%) patients. No new safety signals were identified.
CONCLUSIONS: Overall, the efficacy data from CheckMate 436 do not support the use of nivolumab plus BV for the treatment of R/R DLBCL.
MATERIALS AND METHODS: Adult patients received nivolumab plus BV in 3-week cycles. The primary endpoint was overall response rate (ORR). Here, we report the results from the R/R DLBCL cohort (n = 42).
RESULTS: With a median follow-up of 7.7 months, the ORR was 28.6% (n = 12), and 7.1% (n = 3) of patients achieved a complete response. Median duration of response (95% CI) was 3.6 (1.2-36.5) months. All patients experienced an adverse event (AE), most commonly diarrhea (n = 20, 47.6%). Grade 3/4 and 5 AEs occurred in 24 (57.1%) and 4 (9.5%) patients, respectively. Any-grade treatment-related AEs occurred in 35 (83.3%) patients. No new safety signals were identified.
CONCLUSIONS: Overall, the efficacy data from CheckMate 436 do not support the use of nivolumab plus BV for the treatment of R/R DLBCL.