Five-year follow-up of KEYNOTE-087: pembrolizumab monotherapy for relapsed/refractory classical Hodgkin lymphomaHop St Louis, Hematooncol, Paris, France..
Christie NHS Fdn Trust, Dept Med Oncol, NIHR Clin Res Facil, Manchester, England.;Univ Manchester, Manchester Acad Hlth Sci Ctr, Manchester, England..
Gustave Roussy, Early Drug Dev Dept DITEP, Villejuif, France..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Cancer Immunotherapy.
Natl & Kapodistrian Univ Athens, Laikon Gen Hosp, Dept Hematol & Bone Marrow Transplantat, Athens, Greece..
Nagoya Univ, Grad Sch Med, Dept Hematol & Oncol, Nagoya, Japan..
Univ Cologne, Med Fac, Dept Internal Med 1, Cologne, Germany.;Univ Duisburg Essen, Univ Hosp Essen, West German Canc Ctr, Dept Hematol & Stem Cell Transplantat, Essen, Germany.;Univ Cologne, Univ Hosp Cologne, Cologne, Germany..
Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02215 USA..
City Hope Natl Med Ctr, Dept Hematol Hematopoiet Cell Transplantat, Duarte, CA USA..
Merck & Co Inc, Dept Med Oncol, Rahway, NJ USA..
Merck & Co Inc, Dept Med Oncol, Rahway, NJ USA..
Merck & Co Inc, Dept Med Oncol, Rahway, NJ USA..
Merck & Co Inc, Dept Med Oncol, Rahway, NJ USA..
Univ Miami, Sylvester Comprehens Canc Ctr, Dept Med, Miami, FL USA..
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2023 (English)In: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 142, no 10, p. 878-886Article in journal (Refereed) Published
Abstract [en]
Previous analyses of the phase 2 KEYNOTE-087 (NCT02453594) trial of pembrolizumab monotherapy demonstrated effective antitumor activity with acceptable safety in patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). However, long-term response durability and outcome of patients who receive a second course after treatment discontinuation after complete response (CR) remain of clinical interest. We present KEYNOTE-087 data after >5 years of median follow-up. Patients with R/R cHL and progressive disease (PD) after autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV; cohort 1), salvage chemotherapy and BV without ASCT (cohort 2), or ASCT without subsequent BV (cohort 3), received pembrolizumab for <= 2 years. Patients in CR who discontinued treatment and subsequently experienced PD were eligible for second-course pembrolizumab. Primary end points were the objective response rate (ORR) using blinded central review and safety. The median follow-up was 63.7 months. ORR was 71.4% (95% confidence interval [CI], 64.8-77.4; CR, 27.6%; partial response, 43.8%). Median duration of response (DOR) was 16.6 months; median progression-free survival was 13.7 months. A quarter of responders, including half of complete responders, maintained a response for >= 4 years. Median overall survival was not achieved. Among 20 patients receiving second-course pembrolizumab, ORR for 19 evaluable patients was 73.7% (95% CI, 48.8-90.8); median DOR was 15.2 months. Any-grade treatment-related adverse events occurred in 72.9% of patients and grade 3 or 4 adverse events occurred in 12.9% of patients; no treatment-related deaths occurred. Single-agent pembrolizumab can induce durable responses, particularly in patients achieving CR. Second-course pembrolizumab frequently reinduced sustained responses after relapse from initial CR.
Place, publisher, year, edition, pages
American Society of Hematology, 2023. Vol. 142, no 10, p. 878-886
National Category
Hematology Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-515675DOI: 10.1182/blood.2022019386ISI: 001080772400001PubMedID: 37319435OAI: oai:DiVA.org:uu-515675DiVA, id: diva2:1812674
Note
Correction in: Blood, vol. 144, issue 3, page 341
DOI: 10.1182/blood.2024025229
2023-11-162023-11-162024-08-26Bibliographically approved