11/24/2023 0 Comments Predictive vs prognostic biomarkersAdditional predictive biomarkers are necessary to identify patients most likely to benefit from PD-1–based combination therapy, since tumor cell PD-L1 expression appears to have limited predictive value in this setting. PD-L1 expression on tumor cells and/or the tumor-immune infiltrate is likely only part of the predictive model necessary for selecting patients predisposed to respond to monotherapy. Multiple, distinct, companion assays for PD-L1 positivity have been developed, but there is as yet no comparison, standardization, or prospective validation of these assays. PD-L1 expression has emerged as a potential predictive biomarker for PD-1–directed therapy. Encouraging antitumor activity has also been seen with these agents in patients with other malignancies, including non–small-cell lung cancer and head and neck cancer, tumors not previously thought to be immune-responsive. Pembrolizumab, an anti–PD-1 antibody, recently gained US Food and Drug Administration (FDA) accelerated approval for the treatment of patients with ipilimumab-refractory melanoma, while nivolumab, another anti–PD-1 antibody, and MPD元280A, an anti–programmed cell death 1 ligand (PD-L1) antibody, have been granted FDA “breakthrough designation” for treatment of subsets of patients with refractory Hodgkin lymphoma and metastatic bladder cancer, respectively. Blocking the programmed cell death 1 (PD-1) pathway with monoclonal antibodies has shown promising antitumor responses in clinical trials, with less toxicity than has been seen with prior immune therapies such as interleukin 2 and ipilimumab.
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