Lorbrena significantly reduces the risk of disease progression or death by 72%

Release date: 2026-01-23 14:58:48     Recommended: 11

In December 2020, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib) for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).

Data from the study demonstrated that compared with crizotinib, treatment with lorlatinib significantly reduced the risk of disease progression or death by 72% (hazard ratio [HR] = 0.28, p < 0.001), while also yielding a marked improvement in intracranial response rates (objective response rate [ORR]: 82% vs. 23%; complete response rate [CR]: 71% vs. 8%).

Regarding secondary endpoints, overall survival (OS) data were immature at the time of the interim analysis. In terms of ORR, the Lorbrena group achieved 76% (95% confidence interval [CI]: 68–83) versus 58% (95% CI: 49–66) in the Xalkori group. In addition, Lorbrena exhibited enhanced intracranial activity compared with Xalkori: at the 12-month mark, 96% of patients in the Lorbrena group (95% CI: 91–98) had no central nervous system (CNS) progression, versus 60% in the Xalkori group (95% CI: 0.49–0.69). Among patients with brain metastases (n = 30), the intracranial ORR was 82% in the Lorbrena group (95% CI: 0.57–0.96; n = 14) versus 23% in the Xalkori group (95% CI: 0.05–0.54; n = 3), with intracranial complete response rates (CRR) of 71% and 8%, respectively.

In this study, adverse events (AEs) occurring in more than 20% of patients in the Lorbrena group included hypercholesterolemia (70%), hypertriglyceridemia (64%), edema (55%), weight gain (38%), peripheral neuropathy (34%), cognitive dysfunction (21%), and diarrhea (21%). Grade 3 or 4 AEs were reported in 72% of patients in the Lorbrena group and 56% of those in the Xalkori group. The most common Grade 3 or 4 AEs in the Lorbrena group were hypertriglyceridemia (20%), weight gain (17%), hypercholesterolemia (16%), and hypertension (10%). Adverse events leading to permanent treatment discontinuation occurred in 7% of patients in the Lorbrena group and 9% of those in the Xalkori group.

The above is the latest update on Lorbrena (lorlatinib) for first-line NSCLC treatment: 72% significant reduction in the risk of disease progression or death. For more information about Lorbrena (lorlatinib), please contact our pharmacist consultants directly.