PMID- 32556281 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20210925 IS - 2473-9537 (Electronic) IS - 2473-9529 (Print) IS - 2473-9529 (Linking) VI - 4 IP - 12 DP - 2020 Jun 23 TI - KEYNOTE-013 4-year follow-up of pembrolizumab in classical Hodgkin lymphoma after brentuximab vedotin failure. PG - 2617-2622 LID - 10.1182/bloodadvances.2019001367 [doi] AB - The KEYNOTE-013 study was conducted to evaluate pembrolizumab monotherapy in hematologic malignancies; classical Hodgkin lymphoma (cHL) was an independent expansion cohort. We present long-term results based on >4 years of median follow-up for the cHL cohort. The trial enrolled cHL patients who experienced relapse after, were ineligible for, or declined autologous stem cell transplantation and experienced progression with or did not respond to brentuximab vedotin. Patients received IV pembrolizumab 10 mg/kg every 2 weeks for up to 2 years or until confirmed progression or unacceptable toxicity. Primary end points were safety and complete response (CR) rate by central review. Enrolled patients (N = 31) had received a median of 5 therapies (range, 2 to 15). After a median follow-up of 52.8 months (range, 7.0 to 57.6 months), CR rate was 19%, and median duration of response (DOR) was not reached; 24-month and 36-month DOR rates were both 50% by the Kaplan-Meier method. Median overall survival was not reached; 36-month overall survival was 81%. Six patients (19%) experienced grade 3 treatment-related adverse events (AEs); there were no grade 4 or 5 treatment-related AEs. With long-term follow-up among a heavily pretreated cohort, pembrolizumab had a favorable safety profile; some patients maintained long-term response with pembrolizumab years after end of treatment. This trial was registered at www.clinicaltrials.gov as #NCT01953692. CI - (c) 2020 by The American Society of Hematology. FAU - Armand, Philippe AU - Armand P AD - Dana-Farber Cancer Institute, Boston, MA. FAU - Kuruvilla, John AU - Kuruvilla J AD - UHN Princess Margaret Cancer Centre and University of Toronto, Toronto, ON, Canada. FAU - Michot, Jean-Marie AU - Michot JM AD - Gustave Roussy, Villejuif, France. FAU - Ribrag, Vincent AU - Ribrag V AD - Gustave Roussy, Villejuif, France. FAU - Zinzani, Pier Luigi AU - Zinzani PL AD - Institute of Hematology "Seragnoli," University of Bologna, Bologna, Italy. FAU - Zhu, Ying AU - Zhu Y AD - Merck & Co., Inc., Kenilworth, NJ; and. FAU - Marinello, Patricia AU - Marinello P AD - Merck & Co., Inc., Kenilworth, NJ; and. FAU - Nahar, Akash AU - Nahar A AD - Merck & Co., Inc., Kenilworth, NJ; and. FAU - Moskowitz, Craig H AU - Moskowitz CH AD - University of Miami Sylvester Comprehensive Cancer Center, Miami, FL. LA - eng SI - ClinicalTrials.gov/NCT01953692 PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Blood Adv JT - Blood advances JID - 101698425 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 7XL5ISS668 (Brentuximab Vedotin) RN - DPT0O3T46P (pembrolizumab) SB - IM MH - Antibodies, Monoclonal, Humanized MH - Brentuximab Vedotin MH - Follow-Up Studies MH - *Hematopoietic Stem Cell Transplantation MH - *Hodgkin Disease/drug therapy MH - Humans MH - Neoplasm Recurrence, Local MH - Transplantation, Autologous PMC - PMC7322954 COIS- Conflict-of-interest disclosure: P.A. has received honoraria from Merck & Co., Inc., Bristol-Myers Squibb, Pfizer, Affimed, Adaptive, Infinity, ADC Therapeutics, Celgene, Morphosys, Daiichi Sankyo, Miltenyi, Tessa, GenMab, C4, and Enterome and has received research funding from Merck & Co., Inc., Bristol-Myers Squibb, Affimed, Adaptive, Roche, Tensha, Otsuka, Sigma Tau, Genentech, and IGM. J.K. has been a consultant for Merck & Co., Inc., and has received payment for lectures and speakers' bureaus from Merck & Co., Inc. V.R. has been a consultant/advisor for Gilead, Infinity, Bristol-Myers Squibb, NanoString, and Incyte; has received research funding from ArgenX; has provided expert testimony for Servier; and has received travel, accommodations, and expenses from Roche and Bristol-Myers Squibb. P.L.Z. has served on speakers' bureaus for Verastem, Celltrion, Gilead, Janssen-Cilag, Bristol-Myers Squibb, Servier, Sandoz, Merck & Co., Inc., Immune Design, Celgene, Portola, Roche, Eusapharma, Kyowa Kirin, and Sanofi; has served on advisory boards for Verastem, Celltrion, Gilead, Janssen-Cilag, Bristol-Myers Squibb, Servier, Merck & Co., Inc., Immune Design, Celgene, Portola, Roche, Eusapharma, Kyowa Kirin, and Sanofi; and has been a consultant for Verastem, Merck & Co., Inc., Eusapharma, and Sanofi. Y.Z. and A.N. are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. P.M. is an employee and stockholder of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, and has received travel expenses from Merck & Co., Inc. C.H.M. has held an employment/leadership position/advisory role for Celgene, Genentech, Merck & Co., Seattle Genetics Inc., participated in an advisory board for Molecular Templates, and has received research funding from Pharmacyclics, Genentech, Merck & Co., Inc., and Seattle Genetics Inc. J.-M.M. declares no competing financial interests. EDAT- 2020/06/20 06:00 MHDA- 2021/05/15 06:00 PMCR- 2020/06/17 CRDT- 2020/06/20 06:00 PHST- 2019/12/17 00:00 [received] PHST- 2020/04/15 00:00 [accepted] PHST- 2020/06/20 06:00 [entrez] PHST- 2020/06/20 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/06/17 00:00 [pmc-release] AID - S2473-9529(20)31241-6 [pii] AID - 2019/ADV2019001367 [pii] AID - 10.1182/bloodadvances.2019001367 [doi] PST - ppublish SO - Blood Adv. 2020 Jun 23;4(12):2617-2622. doi: 10.1182/bloodadvances.2019001367.