Back to Top

Phase III CROWN meets primary endpoint PFS in ALKpos, advanced NSCLC

The confirmatory CROWN study compared lorlatinib to crizotinib in tx-naïve, ALKpos NSCLC. The study met its’ primary endpoint (PFS by BIRC) at interim analysis. Data has not been presented but is expected at ESMO 2020.

Lorlatinib (LORBRENA, Pfizer) is the fifth ALK TKI to enter the US market. As a 3rd generation TKI, lorlatinib was designed to target a broader spectrum of ALK mutations, including those associated with acquired resistance to 2nd generation TKIs. A pivotal phase 1/2 study resulted in FDA Breakthrough Designation in 2017, and accelerated approval in 2018, for ALKpos NSCLC progressing on one or more prior ALK TKIs. .

CROWN is one of four phase 3 studies comparing a next generation ALK TKI to crizotinib. So far, the 2nd generation ALK TKIs show very similar PFS benefits vs crizotinib in tx-naïve pts (HR: 0.5). To stand out, the CROWN study would need to show an HR of 0.45 or less.

No further Pfizer-sponsored studies are ongoing.

CROWN: NCT03052608