Janssen Biotech’s Lazertinib was approved by the U.S. Food and Drug Administration in August 2024. It is combined with Rybrevant’s amivantamab-vmjw as first-line therapy treating metastatic non-small cell lung cancer (MSCLC). Amivantamab-vmjw has been approved to treat NSCLC tumors harboring a certain mutation, which is detectable via testing.
Amivantamab-vmjw is characterized as a bispecific antibody. As such, it is a molecule targeting two proteins, MET and EGFR found on NSCLC cells.
The Study
MARIPOSA (NCT04487080) is a new Phase 3 multicenter study that enrolled 1074 patients treated with first-line amivantamab + lazertinib versus osimertinib in EGFR-NSCLC that has metastasized, with no prior metastatic, locally advanced NSCLC or systemic therapy given for disease that has advanced.
Safety and Efficacy were evaluated in MARIPOSA whereby patients received osimertinib or lazertinib monotherapy or amivantamab.
The regimen has not yet been officially approved. The treatment continues until unacceptable toxicity or disease progression.
The Efficacy Outcome Measure
The major outcome measure was progression-free survival (PFS) comparing lazertinib plus amivantamab versus Osimertinib.
Overall survival (OS) was the secondary outcome. Lazertinib with amivantamab was found to have a significant improvement in PFS when compared to osimertinib.
Third-generation EGFR tyrosine kinase inhibitors (TKIs), such as osimertinib, have demonstrated efficacy in patients with EGFR-mutant NSCLC; however, almost all patients will eventually relapse.
Adverse Reactions
Common reactions were typically nail toxicity, rash, edema and other infusion-related events.
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Last modified: September 18, 2024
