New results from a Phase 3 clinical trial comparing Alecensa (alectinib), currently approved as second-line therapy, with Xalkori (crizotinib), currently approved for first-line therapy in people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) found the alectinib-treated group to have a statistically significant improvement in their progressive free survival (PFS).
The results were reported
by Genentech (Roche), the developers of Alecensa (alectinib). The company plans to submit the data to regulatory bodies for review.
Further details of the data are currently unknown. In a news release, Genentech reported that the data will be presented at future medical conferences (aka, ASCO) and submitted to regulatory bodies for review.
This is the second Phase 3 study in which alectinib beat out crizotinib in frontline ALK
Nokihara et al1
showed that alectinib improved PFS by 66% versus crizotinib in the Japanese open-label phase 3 J-ALEX study presented at the 2016 ASCO Annual Meeting. In that study, median PFS was not reached in the alectinib arm, with a lower confidence interval of 20.3 months, compared with a median PFS of 10.2 months in the crizotinib arm (HR, 0.34; P <.0001).
The new study, the phase 3 ALEX study (NCT02075840) randomized 303 treatment-naive patients with ALK
-positive NSCLC in a 1:1 ratio to alectinib or crizotinib. PFS was the primary endpoint of the study, which was conducted at 161 locations across 31 countries.
Approximately 75,000 people are diagnosed with ALK-positive NSCLC every year around the world. It is a distinct form of lung cancer commonly diagnosed in younger people (median age 52).
Nokihara H, Hida T, Kondo M, et al. Alectinib (ALC) versus crizotinib (CRZ) in ALK inhibitor naïve ALK
-positive non-small cell lung cancer (ALK+
NSCLC): Primary results from the J-ALEX study. Presented at: 2016 ASCO Annual Meeting; June 3-7, 2016; Chicago. Abstract 9008.