Ramucirumab and durvalumab for previously treated, advanced non–small-cell lung cancer, gastric/gastro-oesophageal junction adenocarcinoma, or hepatocellular carcinoma: An open-label, phase Ia/b study (JVDJ)
European Journal of Cancer Sep 02, 2020
Bang YJ, Golan T, Dahan L, et al. - Among previously treated patients with advanced non–small-cell lung cancer (NSCLC), gastric/gastro-oesophageal junction adenocarcinoma (gastric/GEJ), or hepatocellular carcinoma (HCC), this 25-center, phase Ia/b single-arm, non-randomized, multi-cohort study was undertaken to evaluate the safety as well as preliminary effectiveness of ramucirumab (an anti-VEGFR2 IgG1) plus durvalumab (an anti–PD-L1 IgG1). Eligible patients were administered ramucirumab (10 mg/kg) plus durvalumab (1,125 mg) intravenously Q3W (NSCLC), or ramucirumab (8 mg/kg) plus durvalumab (750 mg) Q2W (gastric/GEJ, HCC). Phase Ia treatment was considered safe for phase Ib expansion. Final enrolment was NSCLC (n = 28), gastric/GEJ (n = 29), HCC (n = 28), and the occurrence of grade ≥3 treatment–related adverse events was reported in 32.1%, 37.9% and 42.9% of patients, respectively. Median progression-free survival and overall survival were, respectively, 2.7 and 11 months in NSCLC; 2.6 and 12.4 months in gastric/GEJ; 4.4 and 10.7 months in HCC, with more prolonged survival in patients with high PD-L1 expression. Findings demonstrated not only a manageable safety profile for ramucirumab/durvalumab but also, especially in patients with high PD-L1 expression, the antitumour activity of the combination in all cohorts.
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