NEW YORK – The European Commission has expanded the indication for Johnson & Johnson's EGFR-MET bispecific antibody Rybrevant (amivantamab) in combination with the EGFR tyrosine kinase inhibitor Lazcluze (lazertinib) as a first-line treatment of patients with advanced non-small cell lung cancers harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations.
The EC based its decision on results from the Phase III MARIPOSA trial, in which patients with locally advanced or metastatic EGFR-mutated NSCLC on Rybrevant-Lazcluze had improved outcomes compared to those on AstraZeneca's EGFR inhibitor Tagrisso (osimertinib). Patients in the Rybrevant-Lazcluze group had a 30 percent lower risk of disease progression or death compared to those on Tagrisso. The median progression-free survival in the Rybrevant-Lazcluze group was 23.7 months compared to 16.6 months in the Tagrisso group, and the median duration of response was 25.8 months versus 16.8 months, respectively.
EGFR exon 19 deletions and EGFR exon 21 L858R mutations are the most common EGFR alterations among lung cancer patients, showing up in 85 percent to 90 percent of EGFR-mutated NSCLC cases.
"The combination of [Rybrevant] and [Lazcluze] exemplifies the potential of targeted precision medicine, offering a tailored approach that addresses the underlying genetic drivers of the disease, and avoids or delays the need for chemotherapy," Henar Hevia, senior director and EMEA therapeutic area lead for oncology at J&J Innovative Medicine, said in a statement.
A separate marketing authorization decision allowing Lazcluze to be used in this regimen is still pending but received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use last month.
The US Food and Drug Administration approved Rybrevant-Lazcluze in this setting in August 2024. Rybrevant is also approved with chemotherapy as a first-line treatment for advanced NSCLC patients whose tumors harbor EGFR exon 20 insertion mutations. The drug is also approved as a monotherapy for second-line treatment of NSCLC with EGFR exon 20 mutations.