Pfizer has reported that Lorbrena (lorlatinib) demonstrated improvement in progression-free survival (PFS) in first-line anaplastic lymphoma kinase (ALK)-positive advanced lung cancer patients in Phase III CROWN clinical trial.
A tyrosine kinase inhibitor (TKI), Lorbrena was created to hinder tumour mutations that cause resistance to other ALK inhibitors and to cross the blood-brain barrier.
The trial analysed Lorbrena against Xalkori (crizotinib) in ALK-positive advanced non-small cell lung cancer (NSCLC) patients who have not received treatment earlier.
According to the three-year follow-up results, Lorbrena offered a 73% decline in the rate of progression or morality.
This indicates a meaningful improvement on the primary endpoint of PFS, as evaluated by blinded independent central review (BICR), versus Xalkori.
In addition, 64% of subjects in the Lorbrena arm were without disease progression after three years versus 19% in the Xalkori arm.
A secondary endpoint of the trial, objective response rate (ORR) was 77% with Lorbrena treatment and 59% with Xalkori.
Furthermore, Lorbrena resulted in a decline of 92% in the intracranial progression rate.
The safety profile reported in the three-year follow-up assessment was in line with the already reported safety profiles of Lorbrena and Xalkori.
The trial is underway to further assess the secondary endpoint of overall survival, which was not mature at the time of assessment.
Pfizer Global Product Development Oncology chief development officer Chris Boshoff said: “The long-term results from the CROWN trial confirm Lorbrena’s compelling safety and efficacy profile in the first-line setting, providing sustained benefit for up to three years for this patient population.
“Since its first-line approval based on the initial groundbreaking CROWN trial results, Lorbrena has solidified its place as a practice-changing medicine, and these updated data add to the growing body of evidence supporting its use from the onset of metastatic disease.”
In March last year, the US Food and Drug Administration extended approval for use of Lorbrena as a first-line therapy for ALK-positive NSCLC.