publication date: Jun. 2, 2016
Non-Small Cell Lung Cancer
Alecensa Reduces Death Risk by 66 Percent in Phase III Trial
Results from a pre-specified interim analysis from the phase III J-ALEX study found that Alecensa (alectinib) reduced the risk of disease worsening or death by 66 percent compared to (Xalkori) crizotinib in Japanese people with advanced or recurrent ALK-positive non-small cell lung cancer (HR=0.34, 99% CI: 0.17-0.70, p<0.0001) who had not received prior treatment with an ALK inhibitor.
Median PFS was not reached in people who received Alecensa (95% CI: 20.3 months-not reached) versus 10.2 months median PFS (95% CI: 8.2-12.0) in people who received Xalkori.
“This is the first investigational study to show Alecensa helped people live longer without their disease getting worse compared to crizotinib,” said Sandra Horning, chief medical officer and head of Global Product Development at Genentech, the study’s sponsor.
“We believe these efficacy and safety results represent a clinically meaningful advancement for people with ALK-positive lung cancer, and we plan to discuss these data with health authorities, including the FDA.”
The J-ALEX study enrolled 207 people with ALK-positive, advanced … Continue reading CCL May – Alecensa Reduces Death Risk by 66 Percent in Phase III Trial
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