Amivantamab-lazertinib shows OS benefit over osimertinib in Asian EGFR-mutant NSCLC subset
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Key Takeaway
Interpret OS benefit for amivantamab-lazertinib in Asian EGFR-mutant NSCLC with caution as a subset analysis.
This subset analysis of a randomized controlled trial evaluated 629 Asian participants with previously untreated EGFR-mutated, locally advanced or metastatic non-small cell lung cancer. Patients were randomized to receive first-line amivantamab plus lazertinib (n=250), osimertinib (n=251), or lazertinib monotherapy (n=128). The primary outcome for this analysis was overall survival, with a median follow-up of 38.7 months.
The main result showed that amivantamab-lazertinib prolonged overall survival compared to osimertinib, with a hazard ratio of 0.74 (95% CI, 0.56-0.97; nominal P = 0.026). The median overall survival was not reached for the combination therapy group, compared to 38.4 months for the osimertinib group. The 36-month overall survival rate was 61% for amivantamab-lazertinib versus 53% for osimertinib. The safety profile in this Asian subset was reported as consistent with the overall study population, though specific adverse event rates were not reported.
Key limitations include that this is a subset analysis, and the reported P-value is nominal. The median overall survival for the combination arm was not reached, and any projection of a >12-month prolongation is based on an assumption of exponential distribution. The funding source and potential conflicts of interest were not reported. For clinical practice, these results suggest a potential survival benefit for the combination in this specific population, but they should be interpreted with caution pending confirmation from the primary analysis of the full trial population.
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View Original Abstract ↓
BACKGROUND: Approximately 60 % of lung cancer cases occur in Asia, indicating an epidemiological disparity and need for effective therapies. Amivantamab-lazertinib is approved for first-line EGFR-mutated advanced non-small cell lung cancer (NSCLC) in many countries. In the protocol-specified final overall survival (OS) analysis of MARIPOSA (NCT04487080), amivantamab-lazertinib showed a statistically significant and clinically meaningful improvement in OS versus osimertinib (HR, 0.75; P = 0.005) among all participants. We evaluated OS for amivantamab-lazertinib versus osimertinib in Asian participants.
PATIENTS AND METHODS: Participants with previously untreated EGFR-mutated, locally advanced/metastatic NSCLC were randomized 2:2:1 to receive amivantamab-lazertinib, osimertinib, or lazertinib (for evaluating contribution of components). Self-identified Asian race was a stratification factor. OS was a key secondary endpoint.
RESULTS: Of 1074 randomized participants, 629 self-identified as Asian (amivantamab-lazertinib:250; osimertinib:251; lazertinib:128). At a median follow-up of 38.7 months, amivantamab-lazertinib significantly prolonged OS versus osimertinib among Asian participants. Median OS was not reached (NR; 95 % CI, NR-NR) for amivantamab-lazertinib versus 38.4 months (95 % CI, 35.1-NR) for osimertinib (HR, 0.74; 95 % CI, 0.56-0.97; nominal P = 0.026). Assuming exponential distribution of OS in both arms, amivantamab-lazertinib is projected to prolong median OS among Asian participants by > 12 months versus osimertinib. At 36 months, 61 % and 53 % were alive in the amivantamab-lazertinib and osimertinib arms. Safety profile was consistent with the overall population.
CONCLUSIONS: Consistent with the overall population, amivantamab-lazertinib significantly improved OS versus osimertinib among Asian participants with previously untreated EGFR-mutated advanced NSCLC, making it the first regimen to improve survival among Asian patients.
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