NEW YORK – Pfizer on Wednesday announced that its third-generation TKI lorlatinib (Lorbrena) achieved its primary endpoint of improved progression-free survival in the Phase III CROWN trial, and accordingly, the New York-based drug giant intends to seek US Food and Drug Administration (FDA) approval for the agent in previously untreated ALK-positive metastatic NSCLC.
Pfizer plans to announce the results from a planned interim analysis of the CROWN trial at an upcoming medical congress. The randomized trial is evaluating lorlatinib as a first-line treatment option for patients with ALK-positive metastatic non-small cell lung cancer, and is pitting the drug as a monotherapy against crizotinib (Pfizer's Xalkori) monotherapy in a total of 296 patients. According to a statement from Pfizer, the drug's safety profile in the CROWN study is consistent with prior studies.
Lorlatinib was previously granted FDA accelerated approval for patients with ALK-positive metastatic NSCLC who have previously been treated with crizotinib and at least one additional ALK inhibitor, or whose disease has progressed after treatment with either alectinib (Genentech's Alcensa) or ceritinib (Novartis' Zykadia) as the first ALK inhibitor for metastatic disease. In addition to submitting the results of the Phase III CROWN trial to the FDA and other health agencies in the hopes of expanding lorlatinib's approval to this first-line indication, Pfizer also plans to use the results to convert lorlatinib's earlier accelerated approval into a full approval.
"These top-line results of the CROWN study reinforce the significant benefit of Lorbrena demonstrated in later-line settings, and we are excited to share these data soon with physicians and other healthcare providers, as well as engage with global regulatory authorities to potentially provide people with previously untreated metastatic non-small cell lung cancer this third-generation ALK-inhibitor," Chris Boshoff, Pfizer's chief development officer of oncology, global product development, said in a statement.