Nivolumab combined with brentuximab vedotin for R/R primary mediastinal large B-cell lymphoma: a 3-year follow-up

Blood Advances - Tập 7 - Trang 5272-5280 - 2023
Pier Luigi Zinzani1,2, Armando Santoro3, Giuseppe Gritti4, Pauline Brice5, Paul M. Barr6, John Kuruvilla7, David Cunningham8, Justin Kline9, Nathalie A. Johnson10, Neha Mehta-Shah11, Julie Lisano12, Rachael Wen13, Alev Akyol13, Alison J. Moskowitz14
1Lymphoma and Chronic Lymphoproliferative Syndromes Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli,” University of Bologna, Bologna, Italy
2Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy
3Department of Biomedical Sciences, IRCCS Humanitas Research Hospital, Humanitas University, Rozzano-Milan, Italy
4Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, Bergamo, Italy
5Department of Hemato-Oncology, Hôpital Saint-Louis, Paris, France
6Department of Medicine, Hematology/Oncology, University of Rochester, Rochester, NY
7Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada
8Lymphoma Unit, Royal Marsden Hospital, London, United Kingdom
9Section of Hematology / Oncology, University of Chicago, Chicago, IL.
10Division of Hematology, Jewish General Hospital, Montreal, QC, Canada
11Department of Medicine, Division of Oncology, Washington University School of Medicine in St. Louis, St. Louis, MO
12Department of Oncology, Seagen Inc, Bothell, WA
13Bristol-Myers Squibb, Princeton, NJ
14Department of Hematology/Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY

Tóm tắt

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.

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Blood Advances

Tập 7

5272-5280

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