Synapse - Phase II trial of pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin as second-line therapy for relapsed or refractory classical Hodgkin lymphoma

Phase II trial of pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin as second-line therapy for relapsed or refractory classical Hodgkin lymphoma Journal Article

Authors:	Moskowitz, A. J.; Shah, G.; Schöder, H.; Ganesan, N.; Drill, E.; Hancock, H.; Davey, T.; Perez, L.; Ryu, S.; Sohail, S.; Santarosa, A.; Galasso, N.; Neuman, R.; Liotta, B.; Blouin, W.; Kumar, A.; Lahoud, O.; Batlevi, C. L.; Hamlin, P.; Straus, D. J.; Rodriguez-Rivera, I.; Owens, C.; Caron, P.; Intlekofer, A. M.; Hamilton, A.; Horwitz, S. M.; Falchi, L.; Joffe, E.; Johnson, W.; Lee, C.; Palomba, M. L.; Noy, A.; Matasar, M. J.; Pongas, G.; Salles, G.; Vardhana, S.; Sanin, B. W.; von Keudell, G.; Yahalom, J.; Dogan, A.; Zelenetz, A. D.; Moskowitz, C. H.
Article Title:	Phase II trial of pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin as second-line therapy for relapsed or refractory classical Hodgkin lymphoma
Abstract:	PURPOSEWe 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).METHODSTransplant 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/m(2) IV, days 1 and 8), vinorelbine (20 mg/m(2) IV, days 1 and 8), and liposomal doxorubicin (15 mg/m(2), 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.RESULTSOf 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 = 4), neutropenia (n = 4), mucositis (n = 2), thyroiditis (n = 1), and rash (n = 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).CONCLUSIONSecond-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.
Keywords:	chemotherapy; fdg-pet; stem-cell transplantation; positron-emission-tomography; disease; high-dose; multicenter; intensification; brentuximab vedotin; interim; salvage regimen
Journal Title:	Journal of Clinical Oncology
Volume:	39
Issue:	28
ISSN:	0732-183X
Publisher:	American Society of Clinical Oncology
Date Published:	2021-10-01
Start Page:	3109
End Page:	3117
Language:	English
ACCESSION:	WOS:000708641200004
DOI:	10.1200/jco.21.01056
PROVIDER:	wos
PUBMED:	34170745
PMCID:	PMC9851707
Notes:	Article -- Source: Wos