Authors: | Frigault, M. J.; Armand, P.; Redd, R. A.; Jeter, E.; Merryman, R. W.; Coleman, K. C.; Herrera, A. F.; Dahi, P.; Nieto, Y.; LaCasce, A. S.; Fisher, D. C.; Ng, S. Y.; Odejide, O. O.; Freedman, A. S.; Kim, A. I.; Crombie, J. L.; Jacobson, C. A.; Jacobsen, E. D.; Wong, J. L.; Bsat, J.; Patel, S. S.; Ritz, J.; Rodig, S. J.; Shipp, M. A.; Chen, Y. B.; Joyce, R. M. |
Article Title: | PD-1 blockade for diffuse large B-cell lymphoma after autologous stem cell transplantation |
Abstract: | Disease relapse remains the leading cause of failure after autologous stem cell transplantation (ASCT) for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). We conducted a phase 2, multicenter, single-arm study of the anti-PD-1 monoclonal antibody pembrolizumab given after ASCT in patients with chemosensitive DLBCL, hypothesizing that it would improve the progression-free survival (PFS) at 18 months after ASCT (primary endpoint) from 60% to 80%. Pembrolizumab was administered at 200 mg IV every 3 weeks for up to 8 cycles, starting within 21 days of post- ASCT discharge. Twenty-nine patients were treated on this study; 62% completed all 8 cycles. Seventy-nine percent of patients experienced at least one grade 3 or higher adverse event, and 34% experienced at least one grade 2 or higher immune-related adverse event. Overall, 59% of patients were alive and progression free at 18 months, which did not meet the primary endpoint. The 18-month overall survival was 93%. In conclusion, pembrolizumab was successfully administered as post-ASCT consolidation in patients with R/R DLBCL, but the PFS did not meet the protocol-specific primary objective and therefore does not support a larger confirmatory study. © 2020 by The American Society of Hematology. |
Keywords: | adult; cancer survival; clinical article; controlled study; aged; overall survival; neutropenia; hepatitis; drug withdrawal; treatment duration; progression free survival; drug eruption; multiple cycle treatment; phase 2 clinical trial; leukopenia; thrombocytopenia; cohort analysis; autologous stem cell transplantation; febrile neutropenia; pneumonia; multicenter study; receptor blocking; immunopathology; aplastic anemia; programmed death 1 receptor; hypertransaminasemia; diffuse large b cell lymphoma; human; male; female; priority journal; article; pembrolizumab |
Journal Title: | Blood Advances |
Volume: | 4 |
Issue: | 1 |
ISSN: | 2473-9529 |
Publisher: | American Society of Hematology |
Date Published: | 2020-01-14 |
Start Page: | 122 |
End Page: | 126 |
Language: | English |
DOI: | 10.1182/bloodadvances.2019000784 |
PUBMED: | 31917843 |
PROVIDER: | scopus |
PMCID: | PMC6960482 |
DOI/URL: | |
Notes: | Article -- Source: Scopus |