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DewDiligence

12/06/15 6:23 PM

#198007 RE: mcbio #177389

NVS—Midostaurin* OS/HR=0.77 in phase-3 trial in first-line FLT3-mutated AML:

http://finance.yahoo.com/news/novartis-drug-pkc412-midostaurin-improves-161500390.html

Novartis today announced positive results from the global Phase III RATIFY (CALGB 10603) clinical trial. In the study, adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) who received the investigational compound PKC412 (midostaurin) plus standard induction and consolidation chemotherapy experienced a 23% improvement in overall survival (OS) (hazard ratio [HR] = 0.77, P = 0.0074) compared to those treated with standard induction and consolidation chemotherapy alone. The median OS for patients in the PKC412 (midostaurin) treatment group was 74.7 months (95% confidence interval [CI]: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group.



* a/k/a PKC412.