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Amivantamab + Lazertinib Versus Osimertinib as 1L Treatment in EGFR-Mutated Advanced NSCLC: Primary Results From MARIPOSA

Expert oncologist Alex Spira, MD, PhD, FACP, reviews primary results from the MARIPOSA study in advanced NSCLC following the ESMO 2023 annual meeting.

Amivantamab Plus Lazertinib Versus Osimertinib as First-line Treatment in EGFR-mutated Advanced NSCLC: Primary Results from MARIPOSA, a Phase 3, Global, Randomized, Controlled Trial

Background

  • EGFR mutations are present in 15% to 50% of non-squamous advanced NSCLC
  • Secondary EGFR or MET alterations may account for 25% to 50% of tumor resistance
  • Combining amivantamab, an EGFR-MET bispecific, and lazertinib, an EGFR TKI, may improve clinical outcomes without the addition of chemotherapy

Study Design

  • MARIPOSA is phase 3 study combining amivantamab and lazertinib compared to osimertinib as frontline therapy for patients with locally advanced or metastatic NSCLC
    • Patients were treatment-naïve for advanced disease, ECOG PS 0 or 1, and showed documented EGFR Ex19del or L858R
    • Patients were stratified by EGFR mutation type, race, and history of brain metastases
    • Randomization occurred 2:2:1 to amivantamab + lazertinib, osimertinib, or lazertinib
  • Primary endpoint was PFS by BICR per RECIST v1.1
  • Secondary endpoints included OS, ORR, DoR, PFS2, symptomatic PFS, intracranial PFS, and safety

Results

  • Amivantamab + lazertinib reduced the risk of progression or death by 30% and improved median PFS by 7.1 months
  • Amivantamab + lazertinib reduced the risk of extracranial progression or death by 32% and improved median PFS by 9 months
  • Amivantamab + lazertinib showed consistent PFS benefit with or without brain metastases
  • Amivantamab + lazertinib improved median DoR by 9 months, suggesting longer time to resistance and progression
  • Amivantamab + lazertinib reduced the risk of 2nd disease progression or death by 25%
  • Early survival data show a trend favoring amivantamab + lazertinib vs osimertinib
  • Safety profile of amivantamab + lazertinib was consistent with prior reports (higher rates of EGFR- and MET-related AEs and VTEs, majority grade 1-2)
  • Amivantamab + lazertinib represents a new standard of care in patients with first-line, EGFR-mutant advanced NSCLC
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