Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 as Monotherapy for Advanced Pancreatic Cancer

CAR-T Digest - August 2020

13 June 2024: Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 as Monotherapy for Advanced Pancreatic Cancer

Innovent Biologics secured Fast Track Designation from the U.S. FDA for its IBI343 ADC targeting advanced pancreatic ductal adenocarcinoma (PDAC) resistant to one prior therapy
FDA previously approved IBI343’s IND application for PDAC treatment
At ASCO 2024, Innovent presented Phase 1 results of IBI343 in PDAC patients who had undergone at least one prior treatment
Among the evaluable PDAC patients with specific CLDN18.2 expression levels, the 6 mg/kg dose group showed a 40% ORR
These findings indicate potential efficacy of IBI343 in advanced PDAC, signaling progress in managing this difficult cancer