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THOUSAND OAKS, Calif.,
Sept. 11, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the publication of a biomarker analysis of Vectibix
® (panitumumab) in combination with FOLFOX, a type of oxaliplatin-based chemotherapy, for the first-line treatment of patients with metastatic colorectal cancer (mCRC). Published in the
New England Journal of Medicine, the analysis found that
, beyond the known
KRAS exon 2 mutations, predict lack of response to Vectibix in combination with FOLFOX.
RAS mutations are mutations occurring in exons 2, 3 and 4 of
KRAS exon 2 biomarker is well-known and has facilitated selection of patients more likely to respond to anti-EGFR treatment, we found that there were still some patients who didn't benefit from treatment," said
Jean-Yves Douillard, M.D., Ph.D., professor of medical oncology, Centre R Gauducheau,
France and PRIME trial lead investigator and study author. "This analysis is important as it furthers our understanding of tumor genetics and allows physicians to more accurately match patients to effective treatments."
This predefined retrospective subset analysis of the PRIME ('203) study assessed the safety and efficacy of Vectibix plus FOLFOX, compared to FOLFOX alone based on
BRAF mutation status. By more precisely narrowing the pool of patients treated with Vectibix plus FOLFOX to those with wild-type
RAS, greater improvements in overall survival (OS) and progression-free survival (PFS) were observed. Specifically, previous data found that OS was improved by 4.4 months in patients with wild-type
KRAS. By further narrowing to patients with wild-type
RAS, an improvement in OS of 5.8 months was observed.
In patients with wild-type
RAS, OS was 26.0 months and 20.2 months (HR = 0.78; 95 percent CI, 0.62-0.99) and PFS was 10.1 months and 7.9 months (HR = 0.72, 95 percent CI, 0.58-0.90) in the Vectibix plus FOLFOX arm compared to the FOLFOX alone arm, respectively.
BRAF mutations were not observed to have predictive value.
Conversely, in the patients with
RAS mutations, inferior OS (HR = 1.25, 95 percent CI, 1.02-1.55) and PFS (HR = 1.34, 95 percent CI, 1.07-1.60) were observed in the Vectibix plus FOLFOX arm compared to the FOLFOX alone arm. Amgen has informed investigators and physicians of this important new safety information, and is working with regulatory agencies regarding appropriate communication of the outcomes of the analysis.
"Amgen is proud of our continuing work to identify and establish predictive biomarkers, like
RAS, that will help better inform therapeutic decisions," said
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "As a result of this information, the European Commission has refined the prescribing information for Vectibix to the treatment of adult patients with wild-type
RAS metastatic colorectal cancer."
No new safety signals were identified in this analysis.