Nivolumab combined with brentuximab vedotin for R/R primary mediastinal large B-cell lymphoma: a 3-year follow-up.
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Embargo End Date
ICR Authors
Authors
Zinzani, PL
Santoro, A
Gritti, G
Brice, P
Barr, PM
Kuruvilla, J
Cunningham, D
Kline, J
Johnson, NA
Mehta-Shah, N
Lisano, J
Wen, R
Akyol, A
Moskowitz, AJ
Santoro, A
Gritti, G
Brice, P
Barr, PM
Kuruvilla, J
Cunningham, D
Kline, J
Johnson, NA
Mehta-Shah, N
Lisano, J
Wen, R
Akyol, A
Moskowitz, AJ
Document Type
Journal Article
Date
2023-09-26
Date Accepted
2023-06-04
Abstract
Patients with relapsed/refractory primary mediastinal large B-cell lymphoma (R/R PMBL) have poor responses to salvage therapy. Nivolumab and brentuximab vedotin (BV) showed promising early efficacy in patients with R/R PMBL in the phase 1/2 open-label, multicenter CheckMate 436 study; we report safety and efficacy findings from the 3-year follow-up. Patients who were eligible were aged ≥15 years with R/R PMBL previously treated with either high-dose chemotherapy plus autologous hematopoietic cell transplantation (HCT) or ≥2 prior multiagent chemotherapies, and had Eastern Cooperative Oncology Group performance status scores of 0 to 1 and CD30 expression of ≥1%. Patients were treated with nivolumab 240 mg and BV 1.8 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. Primary end point was objective response rate (ORR); secondary end points included complete response rate, duration of response, progression-free survival (PFS), and overall survival (OS). Safety was monitored throughout. At final database lock (30 March 2022), 29 patients had received nivolumab plus BV; median follow-up was 39.6 months. Investigator-assessed ORR was 73.3%; median time to response was 1.3 months (range, 1.1-4.8). Median PFS was 26.0 months; median OS was not reached. PFS and OS rates at 24 months were 55.5% (95% confidence interval [CI], 32.0-73.8) and 75.5% (95% CI, 55.4-87.5), respectively. The most frequently occurring grade 3/4 treatment-related adverse event was neutropenia. Consolidative HCT was received by 12 patients, with a 100-day complete response rate of 100.0%. This 3-year follow-up showed long-term efficacy for nivolumab plus BV in R/R PMBL, with no new safety signals. This trial was registered at www.clinicaltrials.gov as #NCT02581631.
Citation
Blood Advances, 2023, 7 (18), pp. 5272 - 5280
Source Title
Blood Advances
Publisher
American Society of Hematology
ISSN
2473-9529
eISSN
2473-9537
2473-9537
2473-9537
Collections
Research Team
Medicine (RMH)