Title |
SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase 1b, Multicenter Study
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Published in |
Cancer Discovery, October 2018
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DOI | 10.1158/2159-8290.cd-18-0280 |
Pubmed ID | |
Authors |
Antoni Ribas, Theresa Medina, Shivaani Kummar, Asim Amin, Anusha Kalbasi, Joseph J Drabick, Minal Barve, Gregory A Daniels, Deborah J Wong, Emmett V Schmidt, Albert F Candia, Robert L Coffman, Abraham C F Leung, Robert S Janssen |
Abstract |
PD-1 inhibitors are approved for treating advanced melanoma, but resistance has been observed. This phase 1b trial evaluated intratumoral SD-101, a synthetic CpG-oligonucleotide that stimulates Toll-like receptor 9 (TLR9), in combination with pembrolizumab in patients with unresectable or metastatic malignant melanoma. The most common adverse events related to SD-101 were injection site reactions and transient, mild-to-moderate "flu-like" symptoms. Among the 9 patients naïve to anti-PD-1 therapy, the overall response rate (ORR) was 78%. The estimated 12 month progression free survival (PFS) rate was 88%, and overall survival (OS) rate was 89%. Among 13 patients having prior anti-PD-1 therapy, the ORR was 15%. RNA profiling of tumor biopsies demonstrated increased CD8+ T cells, NK cells, cytotoxic cells, dendritic cells, and B cells. The combination of intratumoral SD-101 and pembrolizumab was well tolerated and induced broad immune activation in the tumor microenvironment with durable tumor responses in both peripheral and visceral lesions. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 13 | 37% |
Russia | 2 | 6% |
Switzerland | 1 | 3% |
Germany | 1 | 3% |
United Kingdom | 1 | 3% |
Australia | 1 | 3% |
Japan | 1 | 3% |
France | 1 | 3% |
Unknown | 14 | 40% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 27 | 77% |
Scientists | 4 | 11% |
Science communicators (journalists, bloggers, editors) | 3 | 9% |
Practitioners (doctors, other healthcare professionals) | 1 | 3% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 164 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 34 | 21% |
Student > Ph. D. Student | 24 | 15% |
Other | 18 | 11% |
Student > Bachelor | 11 | 7% |
Student > Master | 11 | 7% |
Other | 17 | 10% |
Unknown | 49 | 30% |
Readers by discipline | Count | As % |
---|---|---|
Biochemistry, Genetics and Molecular Biology | 27 | 16% |
Medicine and Dentistry | 27 | 16% |
Immunology and Microbiology | 17 | 10% |
Agricultural and Biological Sciences | 14 | 9% |
Pharmacology, Toxicology and Pharmaceutical Science | 13 | 8% |
Other | 12 | 7% |
Unknown | 54 | 33% |