NEW YORK | May 29, 2026
Pfizer announced unprecedented seven-year follow-up results from the Phase 3 CROWN trial, demonstrating that LORBRENA® (lorlatinib) delivered the longest progression-free survival reported to date in advanced or metastatic non-small cell lung cancer (NSCLC). The findings, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in Annals of Oncology, reinforce LORBRENA’s position as a preferred first-line treatment for patients with ALK-positive advanced NSCLC.
Seven-Year Results Demonstrate Unmatched Long-Term Disease Control
The updated analysis showed that 55% of patients treated with LORBRENA remained alive without disease progression after seven years, compared with only 3% of patients treated with XALKORI® (crizotinib). Median progression-free survival (PFS) was not reached in the LORBRENA arm, while the therapy reduced the risk of disease progression or death by 81% compared with XALKORI. These results represent one of the most durable outcomes ever reported in metastatic lung cancer and further validate the long-term effectiveness of targeted ALK inhibition.
According to Pfizer, nearly half of the patients enrolled in the trial remain on LORBRENA treatment after seven years, highlighting the durability of clinical benefit. The study’s principal investigators noted that such prolonged disease control was difficult to imagine when ALK-targeted therapies first emerged more than a decade ago.
Strong Protection Against Brain Metastases
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LORBRENA was specifically engineered to overcome resistance mutations and penetrate the blood-brain barrier. The seven-year data demonstrated significant protection against brain metastases, reducing the risk of intracranial disease progression by 94% compared with XALKORI. Importantly, no new intracranial progression events were observed after the first 30 months of treatment among patients receiving LORBRENA.
The median time to intracranial progression was not reached in the LORBRENA arm, whereas patients receiving XALKORI experienced a median intracranial progression time of 16.4 months. These findings underscore LORBRENA’s ability to provide long-term control of both systemic disease and cancer spread to the brain, a major challenge for patients with ALK-positive lung cancer.
Safety Profile Remains Consistent with Previous Studies
The safety findings were consistent with earlier analyses, with no new safety signals identified during extended follow-up. Common adverse events associated with LORBRENA included edema, weight gain, peripheral neuropathy, cognitive effects, mood changes, diarrhea, dyspnea, hypertension, and elevated cholesterol and triglyceride levels. Grade 3 or 4 adverse events occurred more frequently with LORBRENA than with XALKORI; however, treatment discontinuation rates due to adverse events remained low and comparable between both treatment groups.
Researchers reported that no additional permanent treatment discontinuations due to treatment-related adverse events occurred after the first 26 months of therapy, supporting the long-term tolerability of the drug.
LORBRENA Strengthens Position as Standard of Care
The Phase 3 CROWN trial enrolled 296 previously untreated patients with ALK-positive advanced NSCLC and compared LORBRENA with XALKORI in a randomized study. The latest findings build upon previously reported five-year results and further strengthen evidence supporting LORBRENA as a frontline standard of care.
Pfizer stated that the trial continues to follow patients for overall survival outcomes, with future analyses expected to provide additional insights into the long-term impact of treatment. With lung cancer remaining the leading cause of cancer-related deaths worldwide, the company believes the results represent a major advancement for patients living with ALK-positive NSCLC, offering the possibility of prolonged disease control and improved quality of life through a once-daily oral therapy.
Source: Pfizer press release
