Amgen Presents P-III Data for Lumakras and Vectibix in Metastatic Colorectal Cancer at ESMO 2023
Shots:
- The P-III (CodeBreak 300) clinical trial evaluates Lumakras (960 & 240mg) + Vectibix in patients with chemorefractory KRAS G12C-mCRC. The 1EP of the study includes PFS & 2EPs incl. ORR & DCR
- The results depicted a statistically significant PFS of 5.6mos. & 3.9mos. following a median follow-up of 7.8mos. whereas among the 2EPs higher ORR (26% & 6% vs 0%) & DCR (72% & 68% vs 46%) were observed in patients treated with the combination therapy vs investigator's choice of care
- Amgen’s sNDA for Lumakras’ full approval was accepted by the US FDA & has set a PDUFA date of December 24, 2023. Lumakras previously received accelerated approval from the US FDA in May 2021 for the treatment of NSCLC
Ref: PRNewswire | Image: Amgen
Related News:- Amgen Presents P-III (CodeBreaK 200) Trial Results of Lumakras/Lumykras (sotorasib) for Non-Small Cell Lung Cancer at ESMO 2022
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