MARIPOSA
Trial question
What is the role of amivantamab/lazertinib in patients with previously untreated EGFR-positive advanced non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 858
858 patients (332 female, 526 male).
Inclusion criteria: patients with previously untreated EGFR-positive advanced non-small cell lung cancer.
Key exclusion criteria: prior systemic treatment to any time for locally advanced stage III or metastatic stage IV disease; active or past medical history of leptomeningeal disease; untreated spinal cord compression; ILD; symptomatic brain metastases.
Interventions
N=429 amivantamab/lazertinib (amivantamab IV administered weekly at a dose of 1,050 mg for cycle 1 and same dose every 2 weeks for cycle 2 plus lazertinib 240 mg PO daily).
N=429 osimertinib (80 mg PO daily).
Primary outcome
Median progression-free survival
23.7 months
16.6 months
23.7 months
17.8 months
11.8 months
5.9 months
0.0 months
Amivantamab/lazertinib
Osimertinib
Significant
increase ▲
Significant increase in median progression-free survival (23.7 months vs. 16.6 months; HR 1.43, 95% CI 1.18 to 1.72).
Secondary outcomes
No significant difference in objective response (86% vs. 85%; OR 1.15, 95% CI 0.78 to 1.7).
Safety outcomes
No significant difference in adverse event and adverse event leading to death.
Conclusion
In patients with previously untreated EGFR-positive advanced non-small cell lung cancer, amivantamab/lazertinib was superior to osimertinib with respect to median progression-free survival.
Reference
Byoung C Cho, Shun Lu, Enriqueta Felip et al. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024 Jun 26.
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