The PEMDAC phase 2 study of pembrolizumab and entinostat in patients with metastatic uveal melanoma
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Preclinical studies have suggested that epigenetic therapy could enhance immunogenicity of cancer cells. We report the results of the PEMDAC phase 2 clinical trial ( n = 29; NCT02697630) where the HDAC inhibitor entinostat was combined with the PD-1 inhibitor pembrolizumab in patients with metastatic uveal melanoma (UM). The primary endpoint was objective response rate (ORR), and was met with an ORR of 14%. The clinical benefit rate at 18 weeks was 28%, median progression free survival was 2.1 months and the median overall survival was 13.4 months. Toxicities were manageable, and there were no treatment-related deaths. Objective responses and/or prolonged survival were seen in patients with BAP1 wildtype tumors, and in one patient with an iris melanoma that exhibited a UV signature. Longer survival also correlated with low baseline ctDNA levels or LDH. In conclusion, HDAC inhibition and anti-PD1 immunotherapy results in durable responses in a subset of patients with metastatic UM. Trial registration ClinicalTrials.gov registration number: NCT02697630 (registered 3 March 2016). EudraCT registration number: 2016–002114-50.
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Preliminary results of NCT02697630 showed that entinostat plus pembrolizumab induced durable responses in some patients with metastatic uveal melanoma.
“The preliminary results (NCT02697630) showed that entinostat plus pembrolizumab induced durable responses in some patients with metastatic uveal melanoma, and more entinostat-involved combination regimes such as entinostat plus avelumab (NCT02915523), nivolumab (NCT03838042), or M7824 (NCT04708470) are still in clinical evaluation [332].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [332]
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- Authors
- Ny, L., Jespersen, H., Karlsson, J., Alsén, S., Filges, S., All-Eriksson, C., Andersson, B., Carneiro, A., Helgadottir, H., Levin, M., Ljuslinder, I., Olofsson Bagge, R., Sah, V. R., Stierner, U., Ståhlberg, A., Ullenhag, G., Nilsson, L. M., & Nilsson, J. A.
- Affiliations
- Sahlgrenska University Hospital (SE)
- Akershus University Hospital (NO)
- The University of Western Australia (AU)
- Lund University (SE)
- University Hospital of Umeå (SE)
- Uppsala University Hospital (SE)
- Corresponding author
- Ny, Lars
- Nilsson, Jonas A.
- ORCID
- Venue
- Nature Communications
- Published
- 2021-08-27
- Volume
- 12
- Issue
- 1
- Pages
- 5155-5155
- ISSN
- 2041-1723 (ISSN-L)
- PMC
- PMC8397717
- OpenAlex
- W3196177384
- Cited by
- 177
- References
- 85
- Citations by year
- 2026: 19 · 2025: 36 · 2024: 37 · 2023: 42 · 2022: 34 · 2021: 9
- FWCI
- 27.61
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Nature Communications (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion, cc-by)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Lund University Publications (Lund University) (submittedVersion)
- Funders
- Merck
- Knut och Alice Wallenbergs Stiftelse
- Cancerfonden
- Vetenskapsrådet
- Familjen Erling-Perssons Stiftelse
- Topics
- Health Sciences › Medicine › Ophthalmology › Ocular Oncology and Treatments
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Keywords
- pembrolizumab, entinostat, metastatic uveal melanoma, histone deacetylase inhibitors, PD-1 inhibitors, epigenetic therapy, combination immunotherapy, objective response rate, circulating tumor DNA, lactate dehydrogenase, iris melanoma, progression-free survival, overall survival
- MeSH terms
- Progression-Free Survival, Uveal Melanoma, Benzamides, Humans, Melanoma, Pyridines, Uveal Neoplasms, Tumor Suppressor Proteins, Ubiquitin Thiolesterase, Antibodies, Monoclonal, Humanized
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