Ariad Pharmaceuticals Inc fka ARIA

[biotech_researcher]

tste9, here is one reason for my tempered expectations. Another 1st line ALK+ will be approved soon. First mover advantage.

Re: DewDiligence Post# 177516
NVS presents Zykadia phase-3 data in first-line ALK+/NSCLC:

http://finance.yahoo.com/news/novartis-announces-zykadia-first-line-123100438.html
Quote:
Novartis today announced results from its Phase III open-label, randomized, active-controlled, multi-center ASCEND-4 study, which found that patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) treated with first-line Zykadia (ceritinib) had a median progression-free survival (PFS) of 16.6 months (95% confidence interval [CI]: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) in patients treated with standard first-line chemotherapy with maintenance. This equated to a 45% reduction in the risk of disease progression (hazard ratio [HR] = 0.55, P<0.001). Results were presented during the Presidential Symposium at the 17th World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC), in Vienna.

Overall survival data, a key secondary endpoint of the study, are immature; however, a positive trend in favor of Zykadia was observed, despite 72.4% of patients in the chemotherapy arm receiving an ALK inhibitor as their first treatment after discontinuing chemotherapy. Pre-specified secondary endpoints demonstrating the efficacy of Zykadia in ALK+ advanced NSCLC patients included overall response rate (ORR), overall intracranial response rate (OIRR), disease control rate (DCR) and duration of response (DoR).


Dew's commet: Will employ these data to convert Zykadia from an accelerated (FDA)/conditional(EMA) approval to a full approval in both jurisdictions.