TY - JOUR
T1 - Phase II trial of pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin as second-line therapy for relapsed or refractory classical Hodgkin lymphoma
AU - Moskowitz, Alison J.
AU - Shah, Gunjan
AU - Schöder, Heiko
AU - Ganesan, Nivetha
AU - Drill, Esther
AU - Hancock, Helen
AU - Davey, Theresa
AU - Perez, Leslie
AU - Ryu, Sunyoung
AU - Sohail, Samia
AU - Santarosa, Alayna
AU - Galasso, Natasha
AU - Neuman, Rachel
AU - Liotta, Brielle
AU - Blouin, William
AU - Kumar, Anita
AU - Lahoud, Oscar
AU - Batlevi, Connie L.
AU - Hamlin, Paul
AU - Straus, David J.
AU - Rodriguez-Rivera, Ildefonso
AU - Owens, Colette
AU - Caron, Philip
AU - Intlekofer, Andrew M.
AU - Hamilton, Audrey
AU - Horwitz, Steven M.
AU - Falchi, Lorenzo
AU - Joffe, Erel
AU - Johnson, William
AU - Lee, Christina
AU - Palomba, M. Lia
AU - Noy, Ariela
AU - Matasar, Matthew J.
AU - Pongas, Georgios
AU - Salles, Gilles
AU - Vardhana, Santosha
AU - Sanin, Beatriz Wills
AU - von Keudell, Gottfried
AU - Yahalom, Joachim
AU - Dogan, Ahmet
AU - Zelenetz, Andrew D.
AU - Moskowitz, Craig H.
N1 - Funding Information:
Supported by Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. A.J.M. is a Scholar in Clinical Research of The Leukemia & Lymphoma Society.
Publisher Copyright:
© 2021 by American Society of Clinical Oncology
PY - 2021/10/1
Y1 - 2021/10/1
N2 - PURPOSE We conducted a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin (pembro-GVD) as second-line therapy for relapsed or refractory (rel/ref) classical Hodgkin lymphoma (cHL) (ClinicalTrials.gov identifier: NCT03618550). METHODS Transplant eligible patients with rel/ref cHL following first-line therapy were treated with two to four cycles of pembrolizumab (200 mg intravenous [IV], day 1), gemcitabine (1,000 mg/m2 IV, days 1 and 8), vinorelbine (20 mg/m2 IV, days 1 and 8), and liposomal doxorubicin (15 mg/m2, days 1 and 8), given on 21-day cycles. The primary end point was complete response (CR) following up to four cycles of pembro-GVD. Patients who achieved CR by labeled fluorodeoxyglucose-positron emission tomography (Deauville # 3) after two or four cycles proceeded to high-dose therapy and autologous hematopoietic cell transplantation (HDT/AHCT). HDT/AHCT was carried out according to institutional standards, and brentuximab vedotin maintenance was allowed following HDT/AHCT. RESULTS Of 39 patients enrolled, 41% had primary ref disease and 38% relapsed within 1 year of frontline treatment. 31 patients received two cycles of pembro-GVD, and eight received four cycles. Most adverse events were grade 1 or two, whereas few were grade 3 and included transaminitis (n 5 4), neutropenia (n 5 4), mucositis (n 5 2), thyroiditis (n 5 1), and rash (n 5 1). Of 38 evaluable patients, overall and CR rates after pembro-GVD were 100% and 95%, respectively. Thirty-six (95%) patients proceeded to HDT/AHCT, two received pre-HDT/AHCT involved site radiation, and 13 (33%) received post-HDT/AHCT brentuximab vedotin maintenance. All 36 transplanted patients are in remission at a median post-transplant follow-up of 13.5 months (range: 2.66-27.06 months). CONCLUSION Second-line therapy with pembro-GVD is a highly effective and well-tolerated regimen that can efficiently bridge patients with rel/ref cHL to HDT/AHCT.
AB - PURPOSE We conducted a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin (pembro-GVD) as second-line therapy for relapsed or refractory (rel/ref) classical Hodgkin lymphoma (cHL) (ClinicalTrials.gov identifier: NCT03618550). METHODS Transplant eligible patients with rel/ref cHL following first-line therapy were treated with two to four cycles of pembrolizumab (200 mg intravenous [IV], day 1), gemcitabine (1,000 mg/m2 IV, days 1 and 8), vinorelbine (20 mg/m2 IV, days 1 and 8), and liposomal doxorubicin (15 mg/m2, days 1 and 8), given on 21-day cycles. The primary end point was complete response (CR) following up to four cycles of pembro-GVD. Patients who achieved CR by labeled fluorodeoxyglucose-positron emission tomography (Deauville # 3) after two or four cycles proceeded to high-dose therapy and autologous hematopoietic cell transplantation (HDT/AHCT). HDT/AHCT was carried out according to institutional standards, and brentuximab vedotin maintenance was allowed following HDT/AHCT. RESULTS Of 39 patients enrolled, 41% had primary ref disease and 38% relapsed within 1 year of frontline treatment. 31 patients received two cycles of pembro-GVD, and eight received four cycles. Most adverse events were grade 1 or two, whereas few were grade 3 and included transaminitis (n 5 4), neutropenia (n 5 4), mucositis (n 5 2), thyroiditis (n 5 1), and rash (n 5 1). Of 38 evaluable patients, overall and CR rates after pembro-GVD were 100% and 95%, respectively. Thirty-six (95%) patients proceeded to HDT/AHCT, two received pre-HDT/AHCT involved site radiation, and 13 (33%) received post-HDT/AHCT brentuximab vedotin maintenance. All 36 transplanted patients are in remission at a median post-transplant follow-up of 13.5 months (range: 2.66-27.06 months). CONCLUSION Second-line therapy with pembro-GVD is a highly effective and well-tolerated regimen that can efficiently bridge patients with rel/ref cHL to HDT/AHCT.
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U2 - 10.1200/JCO.21.01056
DO - 10.1200/JCO.21.01056
M3 - Article
C2 - 34170745
AN - SCOPUS:85112560169
VL - 39
SP - 3109
EP - 3117
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 28
ER -