Background
The clinical response to anti–programmed cell death 1 (PD‐1) antibodies in patients with advanced gastric and gastroesophageal junction (GEJ) cancer in China has not been reported.
Methods
This study evaluated the efficacy and safety of SHR‐1210, an anti–PD‐1 antibody, in patients with advanced gastric/GEJ cancer in a phase 1 trial. The associations between candidate biomarkers (programmed death ligand 1 [PD‐L1] expression, mismatch repair status, tumor mutation load, and lactate dehydrogenase [LDH] levels) and the efficacy of SHR‐1210 were also explored.
Results
Thirty patients with recurrent or metastatic gastric/GEJ adenocarcinoma who were refractory or intolerant to previous chemotherapy were enrolled between June 2, 2016, and June 8, 2017. Seven patients (23.3%) demonstrated objective responses, including 1 complete response. The objective response rates for patients with PD‐L1–positive and PD‐L1–negative tumors were 23.1% (3 of 13) and 26.7% (4 of 15), respectively (P = 1.000). Two treatment‐related grade 3 or higher adverse events were reported: one was grade 3 pruritus, and the other (3.3%) was grade 5 interstitial lung disease. All 20 patients tested for the mismatch repair status had mismatch repair–proficient tumors, and the response rate was 30.0% (95% confidence interval, 11.9%‐54.3%). Patients with a higher mutation load (4 of 10) tended to have better responses than those with fewer mutations (2 of 10), but the difference was not significant (P = .628). Patients with a >10% relative increase from the baseline LDH level were more likely to experience disease progression (90% [9 of 10]) than patients with a ≤10% change (40% [8 of 20]; P = .017).
Conclusions
Anti–PD‐1 antibody SHR‐1210 shows encouraging efficacy in patients with advanced gastric/GEJ cancer in China, including mismatch repair–proficient subgroups.
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