Pembrolizumab for myelodysplastic syndromes after failure of hypomethylating agents in the phase 1b KEYNOTE-013 study. Issue 7 (7th June 2022)

• Record Type: Journal Article
• Authors: Garcia-Manero, Guillermo; Ribrag, Vincent; Zhang, Yayan; Farooqui, Mohammed; Marinello, Patricia; Smith, B. Douglas
• Is Part Of: Leukemia & lymphoma. Volume 63:Issue 7(2022)
• Page Start: 1660
• Page End: 1668
• Publication Date: 2022-06-07
• Subjects: Hypomethylating agents -- myelodysplastic syndromes -- PD-1 inhibitor -- pembrolizumab; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2022.2034155
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: The phase 1b multicohort KEYNOTE-013 study assessed the safety and antitumor activity of pembrolizumab given at 10 mg/kg/day every 2 weeks for up to 2 years in hematologic malignancies, including myelodysplastic syndromes (MDS) refractory to a hypomethylating agent (HMA). Primary outcomes were safety and objective response rate per International Working Group 2006 criteria. By June 26, 2020, 28 patients were enrolled; median duration of follow-up was 5.6 months (range, 1–78), and 25 patients (89%) had died. Treatment-related adverse events occurred in 10 patients (36%), including 2 (7%) treatment-related discontinuations. No patient achieved complete or partial response. Five patients (19%) had bone marrow complete response, 12 (44%) stable disease, 10 (37%) progressive disease, 6 (22%) cytogenetic response, and 5 (19%) hematologic improvement. Median overall survival (OS) was 6.0 months (95% CI, 4–12); the overall 2-year OS rate was 17%. Pembrolizumab had manageable safety and clinical activity in patients with HMA-refractory MDS. This trial was registered at www.clinicaltrials.gov as #NCT01953692.