Combination of HDAC inhibitor and anti-PD-1 antibody for treatment of cancer
Inventors
Goodenow, Robert • Ordentlich, Peter
Assignees
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Publication Number
US-11324822-B2
Publication Date
2022-05-10
Expiration Date
Abstract
Described herein are methods for the treatment of cancer in a subject. In particular, methods are provided for the treatment of non small cell lung cancer and melanoma with a combination of entinostat and an anti-PD-1 or an anti-PD-L1 antibody.
Core Innovation
The invention relates to a method for treating melanoma or non-small cell lung cancer in a patient in need thereof by administering a combination of therapeutic agents. The therapeutic agents include entinostat and pembrolizumab as the core combination for targeting the PD-1/PD-L1 immune checkpoint pathway together with inhibition of HDACs by entinostat.
A central aspect of the invention is treatment in a patient who previously received a PD-1-blocking antibody or PD-L1-blocking antibody and progressed on prior therapy with a PD-1-blocking antibody or PD-L1-blocking antibody. The disclosed clinical setting includes patients who progressed after prior PD-1/PD-L1 antibody therapy, including embodiments described for NSCLC and melanoma.
The disclosure further characterizes biomarker evaluation and immunomodulatory activity during treatment, including assessment of tumor PD-L1 expression using tumor proportion score (TPS), and evaluation of myeloid-derived suppressor cells (MDSC) and protein lysine acetylation. Preliminary clinical results described include tolerability observations, DLT observations, and immunomodulatory activity such as MDSC decreases, with stable disease observed in some cases.
Claims Coverage
Two independent claims are identified. Both claims focus on administering a combination of entinostat and pembrolizumab for treating melanoma or non-small cell lung cancer in patients who previously received and progressed on PD-1/PD-L1 blocking antibody therapy.
Treating melanoma or non-small cell lung cancer after PD-1/PD-L1 blocking antibody progression with a combination of entinostat and pembrolizumab
A method for treating melanoma or non-small cell lung cancer in a patient in need thereof comprising administering a combination of therapeutic agents to said patient, wherein the therapeutic agents consist essentially of entinostat and pembrolizumab, the patient previously received a PD-1-blocking antibody or PD-L1-blocking antibody, and the patient progressed on prior therapy with a PD-1-blocking antibody or PD-L1-blocking antibody.
Treating melanoma or non-small cell lung cancer after PD-1/PD-L1 blocking antibody progression with a combination of entinostat and pembrolizumab
A method for treating melanoma or non-small cell lung cancer in a patient in need thereof comprising administering a combination of therapeutic agents to said patient, wherein the therapeutic agents consist of entinostat and pembrolizumab, the patient previously received a PD-1-blocking antibody or PD-L1-blocking antibody, and the patient progressed on prior therapy with a PD-1-blocking antibody or PD-L1-blocking antibody.
Across both independent claims, the claim coverage centers on using entinostat together with pembrolizumab to treat melanoma or non-small cell lung cancer in patients who previously received PD-1-blocking or PD-L1-blocking antibodies and progressed on that prior therapy.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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