Dr. Solomon on the Results of the Phase 3 CROWN Study in ALK-Positive NSCLC

Benjamin Solomon, MBBS, PhD, FRACP, consultant medical oncologist, professor, group leader, Molecular Therapeutics and Biomarkers Laboratory, Research Division, Peter MacCallum Cancer Center, discusses interim findings from the phase 3 CROWN study in ALK-positive non–small cell lung cancer (NSCLC).

In the randomized study, treatment-naïve patients with ALK-positive NSCLC were randomized 1:1 to receive 100 mg of lorlatinib ​(Lobrena) daily or 250 mg of crizotinib ​(Xalkori) twice daily. The results​, which were presented during the 2020 ESMO Virtual Congress, showed that lorlatinib significantly prolonged progression-free survival (PFS) by blinded independent central review ​compared with crizotinib, meeting the primary end point of the study, says Solomon. 

Further, the hazard ratio (HR) for PFS was 0.28, which was statistically significant​, explains Solomon. The median PFS with lorlatinib has not yet been reached versus 9.3 months with crizotinib. Moreover, the 12-month landmark PFS rates were 78% and 39%​, respectively.

The investigator-assessed PFS, which was a secondary end point of the study, had a positive HR of 0.21.

Finally, the overall response rate (ORR) ​was 76% with lorlatinib versus 58% ​with crizotinib, Solomon concludes.