Lorbrena (lorlatinib) CROWN study shows majority of patients with ALK-positive advanced lung cancer living beyond five years without disease progression – Pfizer

Pfizer Inc. announced longer-term follow-up results from the Phase III CROWN trial evaluating Lorbrena (lorlatinib, a third-generation ALK inhibitor, 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).

After five years of median follow-up, median progression-free survival (PFS) based on investigator assessment was not reached with Lorbrena, with an observed Hazard Ratio (HR) of 0.19 (95% Confidence Interval [CI], 0.13-0.27), representing an 81% reduction in the rate of disease progression or death compared to Xalkori. Further, 60% of patients treated with Lorbrena (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the Xalkori treatment arm. These data will be presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8503) and have been simultaneously published in the Journal of Clinical Oncology.

“These results from the CROWN trial are unprecedented, as the majority of patients on Lorbrena are living beyond five years without disease progression,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “These results are an excellent example of Pfizer’s long-standing commitment to discovering and developing scientific breakthroughs for patients, and support Lorbrena as a standard of care for the first-line treatment of people with ALK-positive advanced NSCLC.”

Lung cancer is the number one cause of cancer-related death around the world, and an estimated 234,580 new cases of lung cancer are expected to be diagnosed in the U.S. in 2024. NSCLC accounts for approximately 80-85% of lung cancers, with ALK-positive tumors occurring in about 3-5% of NSCLC cases.

See- “Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non–Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study.”-
Authors: Benjamin J. Solomon, MBBS, PhD , Geoffrey Liu, MD , Enriqueta Felip, MD, Tony S.K. Mok, MD , Ross A. Soo, MBBS, PhD , Julien Mazieres, MD , Alice T. Shaw, MD, PhD ,and Todd M. Bauer, MD Publication: Journal of Clinical Oncology https://doi.org/10.1200/JCO.24.00581