Multicenter phase 1b-2 trial of fruquintinib plus sintilimab for previously treated advanced mismatch-repair proficient endometrial cancer

The multicenter phase 1b-2 FRUSICA-1 trial in China evaluates the combination of fruquintinib (TKI) and sintilimab (anti-PD-1) for advanced solid cancers. Results from the endometrial cancer (EMC) cohort have now been published. The cohort included patients with inoperable or advanced mismatch-repair proficient (pMMR) EMC who had progressed on or could not tolerate up to two prior platinum-based therapies. Patients received fruquintinib (5 mg orally once daily, 2 weeks on 1 week off) plus sintilimab (200 mg intravenously once every 3 weeks. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC). Among 98 enrolled patients, the IRC-ORR was 32.7% (95% CI23.5-42.9) and the median progression-free survival was 8.6 months (5.5-16.6). The most common grade ≥ 3 treatment related adverse event was hypertension (17.3% of patients). The authors conclude that the combination of fruquintinb plus sintilimab showed promising efficacy and tolerable safety in previously treated advanced pMMR EMC.