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On the 10th international Rare Disease Day, Amgen is proud to join the global effort and support this year’s theme, “Research”, to bring hope to the millions of people living with a rare disease across the world and their families. In 2016, Amgen continued to bring therapies to patients living with rare diseases, including therapies for rare blood cancers and genetic disorders. As a team in 2017, we look forward to continuing to serve these patients while tirelessly working with researchers, healthcare professionals and advocacy groups to develop innovative therapies to treat individuals affected by some of the more than 7,000 rare diseases worldwide.1 ’s Rare Disease Day, please take a moment to hear from patients living with rare diseases.
The study (GICS abstract #642) showed that patients with wild-type KRAS (exon 2) mCRC treated with Vectibix and BSC achieved a median OS of 10 months compared to 7.4 months for patients treated with BSC alone (hazard ratio [HR]=0.73, 95 percent confidence interval [CI]=0.57-0.93, p=0.0096). Data from a key secondary endpoint showed that patients with wild-type RAS (absence of mutations in exons 2, 3 and 4 of KRAS and NRAS) mCRC treated with Vectibix and BSC achieved a median OS of 10 months compared to 6.9 months for patients treated with BSC alone (n=270; HR=0.70, 95 percent CI=0.53-0.93, p=0.0135). Key secondary endpoints included progression-free survival (PFS) in patients with wild-type KRAS mCRC, as well as OS and PFS in patients with wild-type RAS (absence of mutations in exons 2, 3 and 4 of KRAS and NRAS) mCRC, objective response rate (ORR) and safety in both wild-type KRAS (exon 2) and wild-type RAS groups. For patients with wild-type KRAS, ORRs were 27.0 percent with Vectibix versus 1.6 percent with BSC (HR=24.9, 95 percent CI=7.5-123.8, p RAS, ORRs were 31.0 percent with Vectibix versus 2.3 percent for BSC (ODDS Ratio=20.0, 95 percent CI=5.9-101.6, p Patients with mutant RAS mCRC did not benefit from Vectibix treatment (OS HR=0.99, 95 percent CI=0.49-2.00).