21 Dec Multi-Kinase Inhibitor Midostaurin Plus Chemo Improves AML Survival
MedicalResearch.com Interview with:
Renaud Capdeville, MD
Global Program Head
Oncology Global Development
Medical Research: What is the background for this study? What are the main findings?
Dr. Capdeville: RATIFY (Randomized AML Trial in FLT3 in patients <60 Years Old; CALGB 10603) was a Phase III, international, randomized, placebo-controlled, double-blind group trial of newly-diagnosed (Acute myeloid leukemia, acute myelogenous leukemia) AML patients aged 18 to less than 60 who have a FLT3 mutation.
In the study, patients 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 with 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.
The data, collected and analyzed in partnership with the Alliance for Clinical Trials in Oncology, are from the largest clinical trial in FLT3-mutated AML to date, with 3,279 patients screened and 717 study participants from around the world.
Medical Research: What should clinicians and patients take away from your report?
Dr. Capdeville: The treatment strategy in AML has remained unchanged for more than 25 years. The AML community continues to be in need of new treatment options, especially for those patients with a FLT3 mutation, as they typically have worse outcomes and shorter survival than those without the mutation. Continued research is helping to lead to the development of targeted therapies in AML that may potentially tailor medicine to the disease and improve patient outcomes.
The RATIFY study, in partnership with the Alliance for Clinical Trials in Oncology, reflects Novartis’ relentless pursuit to develop targeted therapies that can improve and extend people’s lives. We plan to submit marketing applications for PKC412 (midostaurin) in FLT3-mutated AML worldwide in the first half of 2016.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Capdeville: We are inspired and motivated to expand science-based innovation to address some of the most challenging issues in AML and are committed to discovering ways to improve and extend people’s lives. Novartis is therefore continuing to investigate PKC412 (midostaurin) in a number of different patient populations. Please visit www.clinicaltrials.gov for additional information.
Stone RM, et al. The Multi-Kinase Inhibitor Midostaurin (M) Prolongs Survival Compared with Placebo (P) in Combination with Daunorubicin (D)/Cytarabine (C) Induction (ind), High-Dose C Consolidation (consol), and As Maintenance (maint) Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients (pts) Age 18-60 with FLT3 Mutations (muts): An International Prospective Randomized (rand) P-Controlled Double-Blind Trial (CALGB 10603/RATIFY [Alliance]). Abstract accepted for presentation at the 2015 ASH Annual Meeting
Renaud Capdeville, MD (2015). Multi-Kinase Inhibitor Midostaurin Plus Chemo Improves AML Survival