New Reference: Alectinib for ALK-Positive Advanced NSCLC

The ALEX study demonstrated that alectinib numerically prolongs overall survival compared to crizotinib in patients with untreated ALK-positive non-small cell lung cancer. Alectinib showed a median overall survival of 81.1 months compared to 54.2 months for crizotinib. Additionally, alectinib provided a longer duration of response than crizotinib. Safety profiles were consistent, confirming alectinib as a standard care in this setting.

Study

Randomized, open-label, multicenter, phase III study [ALEX; NCT02075840]

Treatment-naïve ALK-positive advanced NSCLC

Alectinib (n=152) vs Crizotinib (n=151) until disease progression, unacceptable toxicity, withdrawal, or death.

Efficacy

Median OS: 81.1 mos vs 54.2 mos (HR 0.78 [0.56-1.08])

Median DOR: 42.3 mos vs 11.1 mos (HR 0.41 [0.30-0.56])

Safety

Grade >=3 AEs: Anemia (7.2% vs Not reported), Increased AST (5.3% vs 10.6%), Pneumonia (5.3% vs Not reported), Urinary tract infection (5.3% vs Not reported)

Serious AEs: 46.1% vs 31.8%

Treatment discontinuation due to AEs: 17.8% vs 14.6%