Reference Detail

Ref Type

Journal Article

PMID

(29358502)

Authors

Huang J, Xu B, Mo H, Zhang W, Chen X, Wu D, Qu D, Wang X, Lan B, Yang B, Wang P, Zhang H, Yang Q, Jiao Y

Title

Safety, Activity, and Biomarkers of SHR-1210, an Anti-PD-1 Antibody, for Patients with Advanced Esophageal Carcinoma.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Clinical cancer research : an official journal of the American Association for Cancer Research	24	6	2018 Mar 15	1296-1304	Clin Cancer Res

URL

Abstract Text

Purpose: The current management of advanced esophageal squamous cell carcinoma (ESCC) remains unsatisfactory. We investigated the safety, efficacy, and biomarkers of SHR-1210, an anti-PD-1 antibody, in patients with recurrent or metastatic ESCC.Experimental Design: This study was part of a phase I trial in China. Patients with advanced ESCC who were refractory or intolerant to previous chemotherapy were enrolled. Eligible patients received intravenous SHR-1210 at a dose of 60 mg, with escalation to 200 and 400 mg (4-week interval after first dose followed by a 2-week schedule) until disease progression or intolerable toxicity. The associations between candidate biomarkers (PD-L1 and somatic mutation load) and the efficacy of SHR-1210 were also explored.Results: Between May 11, 2016, and December 9, 2016, a total of 30 patients from one site in China were enrolled. Ten patients (33.3%) had an independently assessed objective response. Median progression-free survival was 3.6 months (95% CI, 0-7.2). Three (10.0%) treatment-related grade 3 adverse events were reported: two (6.7%) pneumonitis and one (3.3%) increased cardiac troponin I. No grade 4 or grade 5 treatment-related adverse events were reported. The exome sequencing and analysis showed that the mutational burden and the potential mutation-associated neoantigen count were associated with better responses. An objective response was more common in patients with PD-L1-positive tumors as defined by ≥5% staining (7 of 15 patients) than in those with PD-L1-negative tumors (1 of 9 patients).Conclusions: In this population of ESCC patients, SHR-1210 had a manageable safety profile and promising antitumor activity. Clin Cancer Res; 24(6); 1296-304. ©2018 AACR.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials
Camrelizumab	Camrelizumab	2	0

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Camrelizumab		SHR-1210\|INCSHR-1210	Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122	Camrelizumab (SHR-1210) is an antibody that targets PD-1 (PDCD1) and inhibits binding of PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in activation of anti-tumor immune response and decreased tumor growth (PMID: 29358502, PMID: 32623573, PMID: 32581041).

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	esophagus squamous cell carcinoma	predicted - sensitive	Camrelizumab	Phase I	Actionable	In a Phase I trial, Camrelizumab (SHR-1210) treatment resulted improved objective response rate (46.7%, 7/15 vs 11.1%, 1/9, p>0.05) and disease control rate (66.7%, 10/15 vs 33.3%, 3/9) in patients with CD274 (PD-L1)-positive advanced esophageal squamous cell carcinoma compared to patients with CD274 (PD-L1)-negative tumors (PMID: 29358502; NCT02742935).	29358502