Pooled analysis of two trials of safety and efficacy of CT041 in patients with refractory metastatic pancreatic cancer

Claudin18.2, an isoform of the tight junction protein claudin18, is highly expressed in pancreatic cancer. CT041 is a claudin18.2-targeted CAR T-cell therapy. Pooled analysis of two phase 1-1b trials at Peking University Cancer Hospital & Institute (Beijing, China) evaluated CT041 in patients with refractory metastatic pancreatic cancer (mPaC). CT041 was safe and tolerable. The overall response rate was 16.7% and the disease control rate was 70.8%. After infusion, the median progression-free survival was 3.3 months (95% CI 1.8-6.2), the median overall survival was 10.0 months (5.5-17.6), and the median duration of response was 9.5 months (2.6-NR). The median PFS (6.0 versus 1.0 months; p<0.001) and median OS (17.6 versus 4.0 months; p<0.001) were longer in patients achieving partial response or stable disease versus progressive disease. The authors conclude that among patients with mPaC after progression on previous therapy, CT041 had a tolerable safety profile and encouraging anticancer efficacy.