Ramucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial

摘要

The prognosis for gastric cancer remains poor, with a median overall survival of approximately 1 year. Ramucirumab and pembrolizumab have each demonstrated antitumor activity and a favorable safety profile as treatments for patients with advanced gastric/gastroesophageal junction (G/GEJ) cancer in the second and third-line setting respectively. However, both agents failed to demonstrate survival benefit over chemotherapy in the first-line setting. Twenty-eight treatment-naïve patients with advanced/metastatic G/GEJ adenocarcinoma were treated with ramucirumab plus pembrolizumab in this phase 1a/b trial. Our results showed that this combination was well tolerated with no unexpected toxicities, and promising durable survival results, particularly among patients with PD-ligand 1 positive tumors. The results of our study therefore support modulating the tumor microenvironment with dual inhibition of VEGFR2 and PD-1 pathways in the first-line patients with advanced G/GEJ cancer.