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news.Amgen has announced the results of a biomarker analysis, which indicated that in metastatic colorectal cancer patients who have failed all other chemotherapeutic regimens, the efficacy of Vectibix monotherapy is confined to patients with non-mutated KRAS tumors.
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Specifically, in patients with non-mutated KRAS tumors, Vectibix significantly increased progression-free survival (PFS) and had an impact on quality of life (QoL) and disease-related symptoms, compared to best supportive care (BSC) alone.
The data was generated from a biomarker analysis of a Phase III, randomized, controlled clinical trial that investigated the treatment effect of Vectibix monotherapy plus BSC versus BSC alone in patients with metastatic colorectal cancer (mCRC). The data showed the relative effect of Vectibix versus BSC was significantly greater in patients with non-mutated versus mutated KRAS (HR = 0.45 versus HR = 0.99). Median PFS in patients without the mutation treated with Vectibix plus BSC was 12.3 weeks versus 7.3 weeks, respectively. When the analysis standardized the time to tumor assessment, the median PFS was 16 weeks versus 8 weeks, respectively (HR= 0.49 vs. 1.07).
Roger Perlmutter, executive vice president of research and development at Amgen, said: “We are hopeful that the use of biomarkers like KRAS will enable improved treatment outcomes for colorectal cancer patients.”