Summary

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• Alecensa (alectinib) is indicated for the treatment of adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test, and for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.
• This summary is based on the review of 45 systematic review(s)/meta-analysis(es). ^[1-45]
• Overall Survival (OS): Alectinib demonstrated the longest OS across multiple studies compared to crizotinib and chemotherapy, with significant improvements in first-line settings. Lorlatinib showed promising OS results, but its efficacy was less consistent, particularly in patients with CNS metastases.
• Progression-Free Survival (PFS): Lorlatinib generally provided the highest PFS, especially in patients with CNS metastases, with alectinib also showing significant PFS benefits in both first-line and second-line settings, notably outperforming crizotinib and ceritinib.
• Objective Response Rate (ORR): Both alectinib and lorlatinib exhibited high ORR, with alectinib showing the best ORR among ALK inhibitors in one study, while lorlatinib showed superior ORR but with a less favorable safety profile.
• Intracranial PFS and CNS Metastases: Lorlatinib was most effective in reducing CNS progression risk, particularly in patients with CNS metastases, with alectinib also showing a significant advantage over crizotinib in CNS PFS.
• Alectinib demonstrated the most favorable safety profile among ALK inhibitors, with fewer grade 3-4 adverse events compared to crizotinib and ceritinib, and was consistently the safest first-line option across multiple studies.
• Ceritinib had the highest incidence of grade 3-5 adverse events, including significant liver toxicity and gastrointestinal adverse events, while lorlatinib was associated with a higher incidence of severe adverse events such as hypertriglyceridemia and hypercholesterolemia.
• Japanese patients treated with ALK inhibitors, including alectinib, experienced a significantly higher incidence of ALK-inhibitor pneumonitis compared to non-Japanese cohorts.
• Increased awareness for hepatotoxicity is necessary in patients with pre-existing conditions receiving ceritinib due to higher incidences of ALT and AST elevations.