KEY TAKEAWAYS
- The MARIPOSA phase 3 trial aimed to compare the efficacy and safety of amivantamab plus lazertinib with osimertinib in patients with EGFR-mutated, advanced NSCLC.
- Amivantamab-lazertinib demonstrated a trend towards improved OS and improved post-progression outcomes compared with osimertinib.
Amivantamab, an EGFR-MET bispecific antibody, and lazertinib, a central nervous system-penetrant third-generation EGFR tyrosine kinase inhibitor (TKI), have shown promising results in treating EGFR-mutated advanced non-small cell lung cancer (NSCLC).
The MARIPOSA trial previously demonstrated the superior progression-free survival (PFS) of the combination therapy compared to osimertinib, another third-generation EGFR TKI, in these patients.
S. Gadgeel and the team aimed to compare the efficacy and safety of amivantamab plus lazertinib with osimertinib in patients with EGFR-mutated, advanced NSCLC.
The study included 1074 patients with treatment-naïve, EGFR-mutated (Exon 19 deletions or Exon 21 L858R substitutions) locally advanced or metastatic NSCLC. Participants were randomized 2:2:1 to receive open-label amivantamab-lazertinib, blinded osimertinib, or blinded lazertinib. The primary analysis compared amivantamab-lazertinib with osimertinib.
With a median follow-up of 31.1 months, 44% and 34% of patients continued treatment in the amivantamab-lazertinib and osimertinib arms, respectively. PFS after subsequent therapy favoured amivantamab-lazertinib (HR, 0.73; 95% CI, 0.59–0.91; nominal P= 0.004).
Amivantamab-lazertinib also showed significantly longer median time to treatment discontinuation and time to subsequent therapy than osimertinib. Although not formally tested for significance, median OS was not estimable for amivantamab-lazertinib vs 37.3 months for osimertinib (HR, 0.77; 95% CI, 0.61–0.96; nominal P= 0.019).
The study concluded that amivantamab-lazertinib showed a trend toward improved overall survival (OS) and post-progression outcomes compared to osimertinib, reinforcing its potential as a first-line standard treatment for EGFR-mutated advanced NSCLC.
The trial was sponsored by Janssen Research & Development, LLC.
Source: https://cattendee.abstractsonline.com/meeting/20598/presentation/3212
Clinical Trial: https://clinicaltrials.gov/study/NCT04487080
Gadgeel S, Cho BC, Lu S, et al. (2024). “Amivantamab plus lazertinib vs osimertinib in first-line EGFR-mutant advanced NSCLC: longer follow-up of the MARIPOSA study.” Presented at: World Conference on Lung Cancer (WCLC); September 8, 2024; Singapore.
