期刊
LEUKEMIA & LYMPHOMA
卷 63, 期 7, 页码 1660-1668出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/10428194.2022.2034155
关键词
Hypomethylating agents; myelodysplastic syndromes; PD-1 inhibitor; pembrolizumab
资金
- Merck Sharp Dohme Corp.
The phase 1b study evaluated the safety and efficacy of pembrolizumab in patients with myelodysplastic syndromes (MDS) refractory to a hypomethylating agent (HMA). The results showed that pembrolizumab had manageable safety and some clinical activity in these patients. However, treatment-related adverse events were relatively common and no patients achieved complete or partial response.
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.
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