Dirozalkib versus Crizotinib in Advanced Anaplastic Lymphoma Kinase Inhibitor-Naïve ALK -Positive Non-Small-Cell Lung Cancer: A Multicenter, Randomized Phase III Trial.
Ying Liu, Xiangjiao Meng, Yan Yu et al.
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In 30 seconds
DIAMOND-2 was a multicenter, randomized, open-label phase III trial comparing dirozalkib with crizotinib in adults with ALK inhibitor-naïve, ALK-positive advanced non-small-cell lung cancer. Patients had received no systemic therapy or had progressed or become intolerant after one chemotherapy regimen. Among 275 participants, investigator-assessed median progression-free survival was 29.5 months with dirozalkib versus 12.9 months with crizotinib (hazard ratio = 0.47, 95% CI = 0.34 to 0.66; P < 0.001). Grade ≥3 treatment-emergent adverse events and adverse-event-related discontinuations were also less frequent with dirozalkib.
Key findings
- Investigator-assessed median PFS was 29.5 months with dirozalkib versus 12.9 months with crizotinib (HR = 0.47, 95% CI = 0.34 to 0.66; P < 0.001).
- Central-review-assessed median PFS was 27.5 months with dirozalkib versus 12.9 months with crizotinib (HR = 0.54, 95% CI = 0.39 to 0.74; P < 0.001).
- Grade ≥3 treatment-emergent adverse events occurred in 60.6% versus 72.5% of patients, respectively.
- Adverse events led to treatment discontinuation in 2.2% with dirozalkib and 7.2% with crizotinib.
Why it matters
The trial provides randomized phase III evidence that dirozalkib can extend progression-free survival compared with crizotinib in ALK inhibitor-naïve advanced NSCLC, with fewer severe treatment-emergent adverse events and discontinuations reported. These efficacy and tolerability outcomes are relevant when considering first-line treatment options, while the findings apply to the trial’s defined patient population.
What to keep in mind
The trial was open-label, and the primary PFS assessment was investigator-assessed; the abstract does not report overall survival results.