OBJECTIVES

: In November 2017, alectinib was approved by the FDA for first-line (1L) treatment of ALK positive metastatic non-small cell lung cancer (ALK+ mNSCLC) based on significantly improved progression free survival compared with crizotinib in the phase 3 ALEX trial. Given the interest in real-world effectiveness of newly approved therapies, this study within the Flatiron Health (FH) electronic health record-derived de-identified database assessed the effectiveness of alectinib treatment of ALK+ mNSCLC in real-world US patients.

METHODS

: A real-world cohort of ALK+ mNSCLC patients initiating alectinib for 1L treatment of mNSCLC from January 2018 to April 2020 were followed-up from treatment initiation to death with patients censored at last known visit, or end of data availability. Baseline characteristics and Kaplan-Meier based cumulative survival probabilities of the real-world cohort were compared with data from the ALEX trial.

RESULTS

: During the study period 130 patients in FH received alectinib as 1L therapy. Based on data recorded, FH and ALEX populations were relatively similar in terms of frequency of brain metastases, stage of disease and histology. However the FH cohort were older (median 62 FH vs 58 ALEX) and, among the 72% of patients with ECOG data available in FH, contained a higher proportion of patients with an ECOG of 2 (16% FH vs 7% ALEX) or 3 (4% FH vs 0% ALEX). Twelve and 24 month survival probabilities in FH were 88% (95% CI 82-95) and 75% (95% CI 65-85) respectively, remarkably similar to the 84% and 73% seen in the ALEX trial.

CONCLUSIONS

: Absolute survival in this real-world cohort of ALK+ mNSCLC patients treated with alectinib was similar to that demonstrated in the ALEX clinical trial. These results suggest the benefit of alectinib demonstrated in clinical trials is being realized in real-world populations.