Innovent’s IBI343 Gains the US FDA’s Fast Track Designation to Treat Pancreatic Cancer
Shots:
- The US FDA has granted fast track designation to IBI343 (recombinant human anti-Claudin 18.2 monoclonal ADC) as a treatment of r/r advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)
- IBI343 is being assessed in the P-I study for its safety, tolerability, DLTs to determine MTD and/or RP2D & preliminary efficacy for treating locally advanced unresectable or metastatic solid tumors across China and Australia
- The results, as of Jan 2024 highlighted at ASCO’24, demonstrated PR achieved by 7/25 patients (PDAC: 5, BTC: 2) with ORR of 28% & DCR of 80%. In the 6mg/kg dose group, ORR was 40% among 10 evaluable PDAC patients with CLDN18.2 1/2/3+≥60%
Ref: Innovent | Image: Innovent
Related News:- Innovent’s IBI343 a Monotherapy Receives the NMPA’s Breakthrough Therapy Designation for Advanced Gastric Cancer (GC)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
