Pfizer has shared positive longer-term follow-up results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Lorbrena (lorlatinib) in advanced non-small cell lung cancer (NSCLC).
The phase 3 CROWN trial has been comparing the drug to Pfizer’s tyrosine kinase inhibitor Xalkori (crizotinib) in patients with previously untreated ALK-positive disease.
Results, presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the Journal of Clinical Oncology, showed that 60% of patients treated with Lorbrena were alive without disease progression after five years compared to 8% of those in the Xalkori cohort.
The updated results also demonstrated an 81% reduction in the rate of disease progression or death and a 94% reduction in the risk of developing intracranial progression in the Lorbrena treatment arm compared to the Xalkori group.
The safety profiles of both drugs in the five-year follow-up were consistent with previous findings, with no new safety signals reported for Lorbrena.
Roger Dansey, chief development officer of oncology at Pfizer, said: “These results from the CROWN trial are unprecedented… 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 globally and NSCLC accounts for up to 85% of all diagnoses.
ALK-positive tumours occur in 3% to 5% of NSCLC cases, translating to approximately 72,000 people who are diagnosed worldwide every year.
Lorlatinib, which already holds approvals to treat certain adults with ALK-positive NSCLC, is designed to inhibit tumour mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.
Principal investigator of CROWN, Benjamin Solomon, Peter MacCallum Cancer Centre, said: “This updated analysis shows that Lorbrena helped patients live longer without disease progression, with the majority of patients experiencing sustained benefit for over five years, including nearly all patients having protection from progression of disease in the brain.
“These improvements in outcomes for patients with ALK-positive NSCLC represent a remarkable advancement in lung cancer.”
The company also presented at ASCO overall survival results from a phase 3 study evaluating Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma.