Novartis says Phase II data for rare lung cancer showed overall response rate of 63%

pharmafile | June 7, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing ASCO, Novartis, Tafinlar, drug trial, lung cancer, mekinist 

Swiss drugmaker Novartis (VTX: NOVN) said combination mid-stage trials for the drug to treat a rare and aggressive form of lung cancer showed an overall response rate in 36 of 57 patients. 

The data included study for multiple investigational and established non-small cell lung cancer (NSCLC) treatments, including results from Phase II study of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) in patients with BRAF V600E-mutation positive  NSCLC. 

Thirty-six of 57 patients showed a clinical response; of these patients, 50% (18 of 36) continued to respond to treatment at the time of analysis, the company said in a statement. 

One-to-two percent (1-2%) of patients with NSCLC have a BRAF V600E mutation, which is associated with more aggressive tumors and a poorer prognosis, independent of smoking status. 

Alessandro Riva, global head of Novartis Oncology Development and Medical Affairs, said: “Lung cancer is the number one cause of cancer death world-wide, and more than half of NSCLC patients’ tumors occur as a result of a genetic mutation. Novartis is fully committed to bringing forth new, targeted options for NSCLC patients, many of whom remain underserved by today’s available therapies.” 

David Planchard, trial’s principal investigator, said: “This study confirms a fourth actionable biomarker in NSCLC – BRAFV600E – after EGFR, ALK and ROS-1. The potential to treat this oncogene gives hope to a very small, underserved patient population.” 

Overall survival rate is the percentage of patients whose cancer shrinks or disappears after treatment. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. 

Combination use of Tafinlar and Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the US, EU, Australia, Canada and additional countries. 

Anjali Shukla

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