Lorlatinib Significantly Improves Progression-Free Survival in Patients with ALK-Positive NSCLC

Lorbrena (generic name: Lorlatinib) is a next-generation tyrosine kinase inhibitor specifically developed to combat tumors that have developed resistance to other ALK inhibitors, with strong blood-brain barrier permeability.

Pfizer Inc. announced the positive results from the interim efficacy analysis of the Phase III clinical trial CROWN. In previously untreated patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), Lorbrena (lorlatinib) significantly improved progression-free survival (PFS) compared with XALKORI (crizotinib), meeting the primary endpoint of the trial.

The safety profiles of lorlatinib and crizotinib were consistent with those observed in previous clinical trials. The results of CROWN will be presented at an upcoming medical conference.

Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC accounts for approximately 80-85% of all lung cancer cases, and ALK positivity is found in roughly 3-5% of NSCLC cases. Prior to the availability of targeted therapy and immunotherapy, the five-year survival rate for patients with advanced NSCLC was only 5%.

About Lorbrena

Lorbrena is a next-generation tyrosine kinase inhibitor (TKI) that exhibits high activity in preclinical lung cancer models harboring ALK chromosomal rearrangements. It is specifically developed to target tumors resistant to other ALK inhibitors and features strong blood-brain barrier permeability.

In 2018, the U.S. Food and Drug Administration (FDA) approved Lorbrena for the treatment of patients with ALK-positive NSCLC whose disease has metastasized after treatment with crizotinib or at least one other ALK inhibitor; and for patients with NSCLC whose disease has progressed after treatment with alectinib or ceritinib as the first-line ALK inhibitor.

About the CROWN Trial

CROWN is a Phase III, randomized, open-label, parallel-arm trial. A total of 296 previously untreated patients with advanced ALK-positive NSCLC were randomized 1:1 to receive either Lorbrena monotherapy or XALKORI monotherapy.

The primary endpoint of the CROWN trial was the improvement in patients’ progression-free survival (PFS). Secondary endpoints included overall survival, objective response (OR), intracranial objective response (IC-OR), time to intracranial progression, duration of response (DR), intracranial duration of response (IC-DR), time to tumor response (TTR), and intracranial time to tumor response (IC-TTR).

Adverse Reactions

Common adverse reactions (≥20%) include edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea.

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