Shots:
- The FDA has approved Lumakras + Vectibix combination to treat metastatic KRAS G12C-mCRC in adults diagnosed via FDA approved test, receiving fluoropyrimidine-, oxaliplatin- & irinotecan-based CT
- The approval was based on P-III (CodeBreaK 300) Trial assessing Lumakras (960mg/240mg, QD) + Vectibix vs investigator’s choice of SoC (n=54; trifluridine/tipiracil or regorafenib) in patients
- The study showed that Lumakras (960mg) + Vectibix (n=53) achieved improved PFS, mPFS (1EP; 5.6 vs 2mos.) & ORR (2EPs; 26% vs 0%), plus OS (2EPs) was insignificant, with mOS not reached vs 10.3 mos. The PFS of Lumakras (240mg) + Vectibix (n=53) was not clinically meaningful
Ref: Amgen | Image: Amgen
Related News:- Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC
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