TY - JOUR
T1 - Pembrolizumab for patients with non-Hodgkin lymphoma
T2 - phase 1b KEYNOTE-013 study
AU - Kuruvilla, John
AU - Armand, Philippe
AU - Hamadani, Mehdi
AU - Kline, Justin
AU - Moskowitz, Craig H.
AU - Avigan, David
AU - Brody, Joshua D.
AU - Ribrag, Vincent
AU - Herrera, Alex F.
AU - Morschhauser, Franck
AU - Kanate, Abraham
AU - Zinzani, Pier Luigi
AU - Bitran, Jacob
AU - Ghesquieres, Herve
AU - Schuster, Stephen J.
AU - Farooqui, Mohammed
AU - Marinello, Patricia
AU - Bartlett, Nancy L.
N1 - Funding Information:
This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. We thank the patients and their families and caregivers, all primary investigators, and their site personnel. We also thank Seth Thompson (Merck & Co., Inc., Rahway, NJ) for his contributions to the statistical analysis. This study and assistance with manuscript preparation were funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ. Medical writing and/or editorial assistance was provided by Dominic Singson, MD, and Matthew Grzywacz, PhD, of ApotheCom (Yardley, PA). This trial was registered at www.clinicaltrials.gov as #NCT01953692.
Publisher Copyright:
© 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2023
Y1 - 2023
N2 - The multicohort phase 1b KEYNOTE-013 study (NCT01953692) evaluated the safety and efficacy of pembrolizumab in patients with relapsed or refractory NHL who were ineligible for or failed hematopoietic cell transplantation (HCT). Patients received pembrolizumab (cohort 4) or pembrolizumab plus lenalidomide (cohort 5). Primary end points were safety and objective response rate (ORR) per IWG 2007 criteria. Cohort 4 included 89 patients. ORR was 22% (19/86; 90% CI 15–31; 10 CR, nine PR); ORRs by disease type were 48% (10/21), 10% (2/20), 12% (5/41), and 50% (2/4), for PMBCL, FL, DLBCL, and ‘other’ NHL, respectively. Toxicity was as predicted. Cohort 5 included 19 patients. ORR was 39% (90% CI 20–61; four CR, three PR). Hematologic toxicities were the most common treatment-related AEs. In conclusion, pembrolizumab following HCT ineligibility/failure confirms prior experience in PMBCL but not with NHL subtypes in this study. Additional analyses in DLBCL may not be warranted.
AB - The multicohort phase 1b KEYNOTE-013 study (NCT01953692) evaluated the safety and efficacy of pembrolizumab in patients with relapsed or refractory NHL who were ineligible for or failed hematopoietic cell transplantation (HCT). Patients received pembrolizumab (cohort 4) or pembrolizumab plus lenalidomide (cohort 5). Primary end points were safety and objective response rate (ORR) per IWG 2007 criteria. Cohort 4 included 89 patients. ORR was 22% (19/86; 90% CI 15–31; 10 CR, nine PR); ORRs by disease type were 48% (10/21), 10% (2/20), 12% (5/41), and 50% (2/4), for PMBCL, FL, DLBCL, and ‘other’ NHL, respectively. Toxicity was as predicted. Cohort 5 included 19 patients. ORR was 39% (90% CI 20–61; four CR, three PR). Hematologic toxicities were the most common treatment-related AEs. In conclusion, pembrolizumab following HCT ineligibility/failure confirms prior experience in PMBCL but not with NHL subtypes in this study. Additional analyses in DLBCL may not be warranted.
KW - B-cell lymphoma
KW - Non-Hodgkin lymphoma
KW - PD-L1
KW - pembrolizumab
UR - http://www.scopus.com/inward/record.url?scp=85142278083&partnerID=8YFLogxK
U2 - 10.1080/10428194.2022.2136956
DO - 10.1080/10428194.2022.2136956
M3 - Article
C2 - 36398795
AN - SCOPUS:85142278083
SN - 1042-8194
VL - 64
SP - 130
EP - 139
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 1
ER -