Shots:
- The NMPA has granted BTD to IBI343 alone for treating CLDN18.2+ advanced pancreatic ductal adenocarcinoma (PDAC) progressed post 1L of systematic therapy
- Designation was based on the ongoing P-I trial of IBI343 (6mg/kg, Q3W) in CLDN18.2+ advanced PDAC patients (n=43) treated with at least 1L of therapy (5% received 2L+ of therapy) across China, Australia & the US. It depicted cORR of 23.3%, PFS in 26 pts & mPFS of 5.3mos. at the data cutoff
- IBI343 (CLDN18.2 ADC) is also in P-III study for GC. It previously received the NMPA’s BTD for CLDN18.2+ GC progressed post 2L of therapy & PDAC progressed post 1L of therapy as well as the FDA’s FTD for r/r advanced unresectable/metastatic PDAC
Ref: Innovent | Image: Innovent
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