Innovent Reports NMPA Approval to the NDA for IBI351 & Grants Priority Review Designation
Shots:
- The NDA approval and Priority Review Designation were based on the P-II study (NCT05005234) evaluating the safety & efficacy of IBI351 monotx. on NSCLC patients (n=264) with KRAS G12C mutation & was intolerant to standard treatment
- Previously, the P-I study data depicted an ORR of 61.2% & DCR of 92.5%, additionally, mDOR was not met yet, the 6-month DoR rate was 75.4% & patients treated with 600mg BID showed better efficacy with ORR of 66.7% & DCR of 96.7%. The median PFS was 8.2mos. & 6 & 9 mos. PFS rate was 58.9% & 47.3%
- IBI351, a KRAS G12C inhibitor, works by covalently and permanently altering the cysteine residue of the KRAS G12C protein
Ref: Innovent | Image: Innovent
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
