Novartis reports data from ASCEND-3, ASCEND-5 trials of Zykadia
Novartis announced updated results from the Phase II ASCEND-3 trial, which demonstrated that anaplastic lymphoma kinase-positive non-small cell lung cancer patients taking Zykadia as their first ALK inhibitor had a median progression-free survival of 18.4 months, with a median follow-up time of 25.9 months. Further, in a sub-analysis of these data, patients who entered the study with brain metastases at baseline experienced an overall response rate of 63.3% and a disease control rate of 83.7%. These results were similar to those in patients without brain metastases, who demonstrated an ORR of 64.0% and DCR of 88.0%. At the time of analysis, the estimated 18-month overall survival rate was 73.4%. This population also demonstrated an ORR of 63.7% and median duration of response of 23.9 months. A decrease in tumor burden from baseline was shown in 94.7% patients. Results from the Phase III ASCEND-5 study were also presented for the first time. The ASCEND-5 study assessed median PFS in patients previously treated with crizotinib and one or two prior regimens of cytotoxic chemotherapy who then received either Zykadia or standard chemotherapy. Results demonstrated a statistically significant and clinically meaningful improvement in median PFS by BIRC for patients taking Zykadia versus chemotherapy. Median PFS by BIRC for Zykadia and chemotherapy were 5.4 months vs. 1.6 months, respectively.