Pfizer’s trial for LORBRENA confirm prolonged progression-free survival ALK-positive advanced lung cancer

April 12, 2022

Pfizer Inc. has announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). These data are being presented, at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract # CT223 / 2). 

This analysis reported after a median follow-up of three years, LORBRENA continued to demonstrate meaningful improvement in progression-free survival (PFS) assessed by blinded independent central review (BICR), the primary endpoint, compared to XALKORI, corresponding to a 73% reduction in the rate of progression or death. 

“Approximately 25-40% of people with ALK-positive advanced non-small cell lung cancer either have brain metastases at diagnosis or develop brain metastases within two years after initial diagnosis, and biomarker-driven medicines like LORBRENA have transformed the way we treat this typically aggressive disease,” said Professor Benjamin Solomon, MBBS, Ph.D., Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia. “The new results from the CROWN trial confirm LORBRENA as a treatment option that significantly improves outcomes for people with previously untreated ALK-positive advanced NSCLC.”  

In this analysis, 64% of people treated with LORBRENA were without disease progression after three years compared to 19% for people treated with XALKORI after the same amount of time. As a secondary endpoint, the objective response rate (ORR) was 77% with LORBRENA (95% CI, 70-84) and 59% with XALKORI. Additionally, LORBRENA treatment resulted in a 92% reduction in the rate of intracranial progression. The intracranial objective response rate (IC-ORR) for people with measurable brain metastases at baseline was 83% with LORBRENA and 23% with XALKORI, with an intracranial complete response rate of 72% and 8%, respectively. In people without brain metastases at baseline, LORBRENA demonstrated a 98% reduction in the rate of intracranial progression. 

In findings published in the New England Journal of Medicine in 2020, the CROWN trial met its primary endpoint by demonstrating significantly improved PFS by BICR, as compared to XALKORI in people with previously untreated ALK-positive advanced NSCLC. 

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