Pfizer's LORBRENA shows 55% seven-year survival without progression
Pfizer Inc. (NYSE: PFE) reported seven-year follow-up results from the Phase 3 CROWN trial showing patients treated with LORBRENA had a 55% likelihood of remaining alive without disease progression compared to 3% for those receiving XALKORI in previously untreated ALK-positive advanced non-small cell lung cancer.
The updated analysis showed that median progression-free survival had not been reached with LORBRENA, representing an 81% reduction in the risk of disease progression or death compared to XALKORI. The results were presented at the American Society of Clinical Oncology Annual Meeting and published simultaneously in Annals of Oncology.
LORBRENA also demonstrated a 94% reduction in the risk of developing brain metastases, with no new intracranial progression events occurring after the first 30 months. At the time of analysis, 44% of patients in the trial were still receiving LORBRENA compared to 3% receiving XALKORI.
The CROWN trial randomized 296 people with previously untreated ALK-positive advanced NSCLC to receive either LORBRENA or XALKORI. ALK-positive tumors occur in about 3-5% of NSCLC cases, with approximately 25-40% of these patients potentially developing brain metastases within two years of initial diagnosis.
Safety profiles remained consistent with previous findings. The most frequent adverse events with LORBRENA included edema, weight gain, peripheral neuropathy, cognitive effects, and mood effects. All-cause grade 3/4 adverse events occurred in 77% of LORBRENA patients versus 57% for XALKORI patients.
LORBRENA is approved in the U.S. for treating adults with metastatic NSCLC whose tumors are ALK-positive and has received approval in more than 80 countries. The drug was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.
