Novartis announces positive top-line results from ASCEND-4, a Phase III trial of Zykadia® in untreated adult ALK+ NSCLC patients

Novartis International AG / Novartis announces positive top-line results from ASCEND-4, a Phase III trial of Zykadia® in untreated adult ALK+ NSCLC patients . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• In a Phase III clinical study, Zykadia^® extended progression-free survival (PFS) when compared with standard chemotherapy, including maintenance 
   
• Novartis is moving forward with global regulatory submissions for this indication; full results will be presented at an upcoming medical congress

Basel, September 23, 2016 - Novartis today announced top-line results from its Phase III ASCEND-4 clinical study for Zykadia^® (ceritinib) in patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). The multicenter, randomized trial (NCT01828099), which assessed the efficacy and safety of Zykadia in previously untreated adult patients, met its primary endpoint, demonstrating clinically significant improvement in progression free survival (PFS) compared to standard chemotherapy, including maintenance.

In addition to PFS, clinically meaningful results were achieved across key secondary efficacy measures, including objective response rate (ORR) and duration of response (DoR). The adverse events observed were consistent with the previously known adverse event profile of Zykadia. A full analysis of ASCEND-4 data along with detailed efficacy and safety results will be submitted for presentation at a major medical congress.

"Zykadia has proven to be an important treatment option for ALK+ NSCLC patients who have progressed following treatment with crizotinib," said Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology. "We are pleased to see these topline results show promise in untreated patients with advanced disease, and look forward to sharing these data with regulatory authorities in the coming months."

Of more than 1.8 million lung cancer diagnoses each year, approximately 2-7% of cases have the ALK gene rearrangement[1],[2]. These patients are candidates for treatment with a targeted ALK inhibitor[2].

About ASCEND-4
ASCEND-4 was a Phase III randomized, open label, multicenter global clinical trial to evaluate the safety and efficacy of Zykadia compared to standard chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK+ NSCLC who received no prior therapy for their advanced disease.