Amgen Reports Results of Lumakras in P-III Trial for the Treatment of Non-Small Cell Lung Cancer
Shots:
- The P-III (CodeBreak 200) trial evaluates the safety & efficacy of Lumakras (sotorasib) vs docetaxel in patients (n=345) with KRAS G12C-mutated NSCLC. The study includes PFS as its 1EPs whereas OS, ORR & patient-reported outcomes were the 2EPs
- The results from the study showed the 1EPs of PFS were met, indicating a statistical significance vs docetaxel. Amgen is also evaluating Lumakras under the P-I & II (CodeBreak 100) study in patients (n=126) with CRC & P-Ib (CodeBreak 101) in patients with various advanced solid tumors
- Lumakras has previously been approved in ≥40 markets globally incl. the US, EU & Japan among others. Amgen has submitted MAAs in Argentina, Colombia, Kuwait, Malaysia, Mexico, Saudi Arabia, Thailand & Turkey
Ref: PR Newswire | Image: Amgen
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