Pfizer's Third-Generation ALK Inhibitor Lorbrena Meets Primary Endpoint in Phase 3 CROWN Trial for First-Line Treatment of NSCLC

Pfizer Announces That Lorbrena (lorlatinib), Its Third-Generation ALK Inhibitor, Met the Primary Endpoint in the Phase 3 CROWN Trial in Patients With Previously Untreated Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC). The Study Demonstrated That Lorbrena (lorlatinib) Significantly Improved Progression-Free Survival (PFS) Compared With an Active Comparator ALK Inhibitor. Results From the CROWN Trial Will Be Presented at an Upcoming Medical Conference.

Lung cancer is the leading cause of cancer-related deaths worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80-85% of all lung cancer cases, with about 3-5% of NSCLC cases harboring ALK-positive tumors. Prior to the advent of targeted therapies and immunotherapy, the five-year survival rate for patients with advanced NSCLC was only 5%.

Lorbrena is a tyrosine kinase inhibitor (TKI) that has demonstrated high activity in preclinical lung cancer models harboring ALK rearrangements. Lorbrena was specifically developed to inhibit ALK gene mutations resistant to other ALK inhibitors and can penetrate the blood-brain barrier. In 2018, the U.S. FDA granted accelerated approval of Lorbrena for the treatment of patients with previously treated ALK-positive metastatic non-small cell lung cancer (NSCLC). The CROWN clinical trial served as the confirmatory study for this accelerated approval. Based on the positive results from this trial, Pfizer will seek to convert the accelerated approval to full approval from the FDA and will also seek approval for the treatment of previously untreated patients with ALK-positive metastatic NSCLC.

Dr. Chris Boshoff, Chief Development Officer of Pfizer’s Global Product Development Oncology Division, stated: “We are pleased to share these data with physicians and other healthcare providers as soon as possible, and to collaborate with regulatory authorities worldwide to make this third-generation ALK inhibitor available to patients with previously untreated metastatic non-small cell lung cancer at the earliest opportunity.”

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