A phase 2 study of pembrolizumab after autologous stem cell transplantation in patients with T-cell non-Hodgkin lymphoma Journal Article
| Authors: | Merrill, M. H.; Dahi, P. B.; Redd, R. A.; McDonough, M. M.; Chen, Y. B.; DeFilipp, Z.; Herrera, A. F.; Fisher, D. C.; LaCasce, A. S.; Odejide, O. O.; Ng, S. Y.; Jacobson, C. A.; Merryman, R. W.; Kim, A. I.; Nieto, Y. L.; Sauter, C. S.; Shah, G. L.; Zain, J. M.; Armand, P.; Jacobsen, E. D. |
| Article Title: | A phase 2 study of pembrolizumab after autologous stem cell transplantation in patients with T-cell non-Hodgkin lymphoma |
| Abstract: | Autologous stem cell transplantation (ASCT) is often used as consolidation for several subtypes of peripheral T-cell lymphoma (PTCL) in first remission. However, many patients relapse after ASCT and have a very poor prognosis. There are no approved treatment options for posttransplantation maintenance or consolidation in PTCL. PD-1 blockade has demonstrated some efficacy for patients with PTCL. We, therefore, conducted a phase 2 multicenter study of the anti–PD-1 monoclonal antibody pembrolizumab after ASCT in patients with PTCL in first remission. Pembrolizumab was administered at 200 mg IV every 3 weeks for up to 8 cycles within 21 days from post-ASCT discharge (and within 60 days of stem cell infusion). The primary end point was progression-free survival (PFS) at 18 months after ASCT. Twenty-one patients were treated in this study and 67% (n = 14) completed 8 cycles of treatment. Among all patients who were evaluable, 13 of 21 were alive and achieved PFS at 18 months after ASCT, meeting the study's primary end point. The estimated 18-month PFS was 83.6% (95% confidence interval [CI], 68-100), and overall survival 94.4% (95% CI, 84-100). The toxicity profile was consistent with the known toxicity profile of pembrolizumab, with no grade 5 toxicities. In conclusion, PD-1 blockade after ASCT with pembrolizumab is feasible with a favorable safety profile and promising activity, supporting further confirmatory studies. This trial was registered at www.clinicaltrials.gov as #NCT02362997. © 2023 The American Society of Hematology |
| Keywords: | adult; clinical article; controlled study; treatment response; aged; disease-free survival; middle aged; overall survival; clinical trial; diarrhea; drug efficacy; drug safety; drug withdrawal; side effect; cancer patient; disease free survival; cancer staging; antineoplastic agent; t lymphocyte; t-lymphocytes; progression free survival; multiple cycle treatment; phase 2 clinical trial; neoplasm recurrence, local; nausea; antineoplastic combined chemotherapy protocols; cohort analysis; steroid; autologous stem cell transplantation; stem cell transplantation; hematopoietic stem cell transplantation; pathology; abdominal pain; arthralgia; alkaline phosphatase; cancer regression; peripheral t cell lymphoma; multicenter study; tumor recurrence; colitis; open study; flu like syndrome; headache; hyperthyroidism; hypothyroidism; transplantation, autologous; nose obstruction; respiratory failure; neuralgia; etiology; lymphoma, t-cell, peripheral; autotransplantation; hypertransaminasemia; anaplastic large cell lymphoma; body weight loss; cancer prognosis; noncardiac chest pain; humans; human; male; female; article; pembrolizumab; alkaline phosphatase level |
| Journal Title: | Blood |
| Volume: | 142 |
| Issue: | 7 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2023-08-17 |
| Start Page: | 621 |
| End Page: | 628 |
| Language: | English |
| DOI: | 10.1182/blood.2023020244 |
| PUBMED: | 37319432 |
| PROVIDER: | scopus |
| PMCID: | PMC10934277 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work