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On 2 April 2019, Stefan Barta from the Fox Chase Cancer Center & the University of Pennsylvania, Pennsylvania, PA, USA, and colleagues, published in Clinical Lymphoma, Myeloma & Leukemia results from the first prospective phase II trial (NCT02535247) that investigated the efficacy of pembrolizumab for the treatment of relapsed of refractory (R/R) mature T-cell lymphoma.
Pembrolizumab is a programmed cell death-1 (PD-1) inhibitor. Since PD-1 along with its ligand PD-L1 are commonly expressed in T-cell lymphomas and considering the current unmet need for patients with R/R T-cell lymphomas, the investigators sought to examine whether pembrolizumab is safe and can provide durable responses in this setting. The primary endpoint of this multicenter, prospective, single-arm, phase II trial was progression-free survival (PFS). Secondary outcomes included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety.
Patients (response data) |
N = 15 |
|
---|---|---|
ORR (n) |
33% (n = 5) |
95% CI, 9−57 |
Complete response (CR; n) |
27% (n = 4) |
95% CI, 4−49 |
Median time to best response (range) |
114 (81−146) days |
|
Median follow-up |
5.9 months |
95% CI, 0−18 |
Median PFS |
3.2 months |
95% CI, 1.2−3.7 |
Median OS |
10.6 months |
95% CI, 3.2−100 |
According to the authors, the ORR observed in this trial (33%), with single-agent pembrolizumab in patients with R/R T-cell lymphoma, is comparable to other available monotherapy agents. In general, the PD-1 inhibitor showed modest activity and the expected toxicity profile. The main limitation of this study was its small sample size. Larger prospective studies are needed to validate the results of this trial.
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