On Aug. 20, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.1,2
A press release on the announcement says that “Lung cancer is the leading cause of cancer mortality worldwide, resulting in 1.8 million deaths each year, with NSCLC accounting for 80% to 85% of all cases.3,4 Of patients with EGFR-mutated NSCLC, between 25% and 39% never receive second-line therapy, due to disease progression and lack of treatment options. The five-year survival rate is less than 20% for all people with advanced EGFR-mutated NSCLC treated with current standard of care TKI monotherapy. Acquired resistance mechanisms after TKI monotherapy makes subsequent treatment more difficult.”
Further, “The FDA approval is based on positive results from the Phase 3 MARIPOSA study, which showed RYBREVANT plus LAZCLUZE reduced the risk of disease progression or death by 30% compared to osimertinib (median progression-free survival [PFS]: 23.7 months versus 16.6 months) in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The median duration of response (DOR) was nine months longer with RYBREVANT plus LAZCLUZE versus osimertinib (25.8 months versus 16.7 months), a secondary endpoint of the study.”
