A groundbreaking phase 3 clinical trial has revealed that lorlatinib, a third-generation ALK tyrosine kinase inhibitor, has achieved the longest progression-free survival (PFS) ever reported in patients with advanced ALK-positive non-small cell lung cancer (NSCLC).
Lorlatinib Outperforms Crizotinib in Advanced ALK+ NSCLC
The study, presented at the recent American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated a remarkable 60% 5-year PFS rate with lorlatinib, compared to a mere 8% with crizotinib, a first-generation ALK inhibitor.
The trial, led by Dr. Benjamin Solomon from the Peter MacCallum Cancer Centre in Melbourne, Australia, randomized 296 patients with advanced ALK+ NSCLC to receive either lorlatinib (n=149) or crizotinib (n=147, with 142 ultimately treated).
Notably, 25% of the participants had brain metastases at baseline, highlighting the critical need for effective therapies that can penetrate the central nervous system.
Key Findings from the Lorlatinib vs. Crizotinib Study
Key findings from the study include:
- 5-year PFS: 60% with lorlatinib vs. 8% with crizotinib
- Median PFS: Not reached with lorlatinib vs. 9.3 months with crizotinib
- Most common adverse events with lorlatinib: Edema, hypercholesterolemia, and hypertriglyceridemia
Lorlatinib’s Superiority in Controlling ALK+ NSCLC and Brain Metastases
These results clearly demonstrate the superiority of lorlatinib over crizotinib in controlling ALK+ NSCLC, including brain metastases.
The unprecedented 5-year PFS rate offers new hope for patients in Ukraine, Kazakhstan, and worldwide who are battling this devastating disease.
While longer follow-up is necessary to evaluate the impact on overall survival, lorlatinib’s ability to provide durable disease control and prevent progression, even after 5 years, represents a significant advancement in the treatment of ALK+ NSCLC.
About Lorlatinib (Lorbrena/Lorviqua)
Lorlatinib, marketed as Lorbrena (United States, Canada, Japan) or Lorviqua (European Union), is a third-generation ALK and ROS1 tyrosine kinase inhibitor developed by Pfizer.
It is approved for the treatment of advanced ALK-positive non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to previous ALK inhibitor therapy, such as crizotinib, alectinib, or ceritinib.
Key features of lorlatinib include:
- Potent and selective inhibition of ALK and ROS1 tyrosine kinases
- Ability to penetrate the blood-brain barrier and control brain metastases
- Efficacy in patients with resistance mutations to first- and second-generation ALK inhibitors
Lorlatinib appears to be registered in Russia as Loriviqua. However, it is not yet registered in Ukraine, Kazakhstan or elsewhere in the CIS.
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