Multicenter phase 3 trial of fruquintinib plus paclitaxel for advanced gastric or gastroesophageal junction adenocarcinoma

The VEGF pathway plays a key role in the pathogenesis of gastric cancer. Fruquintinib is an inhibitor of VEGFR1/2/3/4. The multicenter phase 3 FRUTIGA trial in China compared fruquintinib plus paclitaxel versus placebo plus paclitaxel in patients with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma who progressed on fluorouracil- and platinum-containing chemotherapy. The co-primary endpoints were progression-free and overall survival. The median PFS was 5.6 months in the fruquintinib group versus 2.7 months in the placebo group (HR 0.57; p<0.0001), meeting the PFS endpoint. The OS endpoint was not met with median OS 9.6 months in the fruquintinib group versus 8.4 months in the placebo group (HR 0.96; p=0.6064). The most common grade ≥ 3 adverse events were neutropenia, leukopenia, and anemia. The authors conclude that fruquintinib plus paclitaxel as second-line treatment for advanced G/GEJ adenocarcinoma in Chinese patients significantly improved PFS but not OS.