Pfizer’s LORBRENA® CROWN Trial Reveals Prolonged Progression-Free Survival for Most ALK-Positive Advanced Lung Cancer Patients Over Five Years

Today, Pfizer released extended findings from the Phase 3 CROWN trial, examining the efficacy of LORBRENA® (lorlatinib), a third-generation ALK inhibitor, versus XALKORI® (crizotinib) in previously untreated patients with ALK-positive advanced non-small cell lung cancer (NSCLC). Following a median follow-up of five years, LORBRENA demonstrated a remarkable median progression-free survival (PFS) not reached, with an observed Hazard Ratio (HR) of 0.19. This translates to an 81% reduction in the rate of disease progression or death compared to XALKORI. Moreover, 60% of patients on LORBRENA were alive without disease progression after five years, contrasting with only 8% on XALKORI.

These findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the Journal of Clinical Oncology, mark a significant milestone in the treatment of ALK-positive advanced NSCLC. Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer, emphasized the unprecedented nature of these results, underlining Pfizer’s commitment to pioneering breakthroughs in patient care.

Lung cancer, the leading cause of cancer-related deaths globally, poses a significant health challenge. Approximately 80-85% of lung cancers are non-small cell lung cancer (NSCLC), with ALK-positive tumors accounting for about 3-5% of cases. LORBRENA, developed by Pfizer, specifically targets tumor mutations resistant to other ALK inhibitors and can penetrate the blood-brain barrier, critical in addressing brain metastases common in ALK-positive NSCLC.

Benjamin Solomon, MBBS, Ph.D., emphasized the aggressive nature of ALK-positive advanced NSCLC and the impact on patients’ lives. He highlighted LORBRENA’s role in extending progression-free survival, with the majority of patients experiencing sustained benefits for over five years, notably in protection against brain metastases.

Further analysis revealed a 94% reduction in the risk of intracranial progression with LORBRENA compared to XALKORI. Notably, LORBRENA significantly reduced the incidence of brain metastases in patients without baseline brain involvement.

Kenneth Culver, M.D., of the non-profit organization ALK Positive, emphasized the significance of these results for the ALK-positive lung cancer community, indicating a notable advancement in targeted treatment outcomes.

Safety profiles of LORBRENA and XALKORI remained consistent with previous findings, with no new safety concerns for LORBRENA. Most adverse events reported with LORBRENA were consistent with previous analyses, including edema, weight gain, and peripheral neuropathy.

Pfizer continues to prioritize accessibility and understanding of its research findings, offering abstract plain language summaries (APLS) for its research presented at ASCO, facilitating broader comprehension among diverse audiences.

The CROWN trial, a Phase 3, randomized study involving 296 previously untreated ALK-positive advanced NSCLC patients, reaffirms LORBRENA’s efficacy and safety. With Pfizer’s commitment to advancing cancer care and its robust portfolio, including LORBRENA, the quest to redefine treatment standards for patients with ALK-positive NSCLC continues.”

Note: The safety information for LORBRENA® (lorlatinib) and XALKORI® (crizotinib) has been condensed for brevity.

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