Chugai Pharmaceutical Co. Ltd. said a global phase 3 study showed Alecensa, or alectinib, demonstrated statistically significant improvement in progression-free survival and reduced risk of central nervous system progression or death in patients with lung cancer.
The study evaluated alectinib versus crizotinib in treatment-naive advanced anaplastic lymphoma kinase-positive non-small cell lung cancer.
According to the investigators' assessment, the Alecensa arm showed statistically significant improvement superiority compared to the crizotinib arm, reducing risk of progression or death by 53%. Median progression-free survival was not reached in the experimental arm, and reached 11.1 months in the crizotinib arm.
According to an independent review committee, the Alecensa arm reduced risk of progression or death by 50%. Median progression-free survival was 25.7 months in the Alecensa arm and was 10.4 months in the crizotinib arm.
The Alecensa arm also showed reduced risk of central nervous system progression or death by 84%, compared to the crizotinib arm.
Chugai considered overall survival data immature, with only about a quarter of events being reported.
Grade 3-5 adverse events with the Alecensa arm reached 41%, compared to 50% with the crizotinib arm. No new safety findings were observed in either treatment arm.