Additional Relevant Details

• The median Duration of Response for BRAF V600E-mutant NSCLC patients treated with Tafinlar + Mekinist combination therapy was 9 months
   
• Efficacy analyses also presented for INC280 (capmatinib) in cMET+ NSCLC 
   
• Novartis' growing commitment in treating NSCLC supported by data for three distinct targeted therapies

Basel, June 6, 2016 - Novartis today announced new data for multiple investigational and established non-small cell lung cancer (NSCLC) treatments, including results from a pivotal, Phase II study of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) in patients with BRAF V600E-mutation positive (BRAF V600E­+) NSCLC. In the study, patients treated with Tafinlar + Mekinist demonstrated an overall response rate (ORR) of 63% (95% CI, 49%-76%)[1]. Data were presented during an oral session at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) and also published simultaneously in The Lancet Oncology."This study confirms a fourth actionable biomarker in NSCLC - BRAFV600E - after EGFR, ALK and ROS-1," said David Planchard, MD, PhD, Thoracic Oncology Specialist, Cancer Institute Gustave-Roussy, Villejuif, France and trial's principal investigator. "The potential to treat this oncogene gives hope to a very small, underserved patient population."One-to-two percent (1-2%) of patients with NSCLC have a BRAF V600E mutation[2], which is associated with more aggressive tumors and a poorer prognosis, independent of smoking status[3].In this Phase II, multicenter, non-randomized, open-label study (NCT01336634), 57 patients with metastatic NSCLC who had the BRAF V600E mutation and failed at least one line of chemotherapy took 150 mg of Tafinlar twice daily and 2 mg of Mekinist once daily. The primary endpoint of the trial was investigator-assessed ORR, and key secondary endpoints were Duration of Response (DoR) and Progression-Free Survival (PFS). Independent review response rates were consistent with investigator-assessed response[1].The investigator-assessed median DoR and PFS were 9.0 months (95% CI, 6.9 to 18.3) and 9.7 months (95% CI, 6.9 to 19.6), respectively. Thirty-six of 57 patients (63%) demonstrated a clinical response; of these patients, 50% (18 of 36) continued to respond to treatment at the time of analysis. The most common adverse events (incidence >20%) were pyrexia, nausea, vomiting, diarrhea, asthenia, decreased appetite, dry skin, chills, peripheral edema, cough and rash[1]. Four patients (7%) died from fatal adverse events not related to study treatment as assessed by the investigator[1].