Johnson & Johnson has announced The New England Journal of Medicine (NEJM) published results from the phase 3 MARIPOSA study.
The results showed RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement for patients with previously untreated (first-line) locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
At a median follow-up of 37.8 months, RYBREVANT plus LAZCLUZE showed a statistically significant reduction in the risk of death compared to osimertinib (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.61-0.92, P=0.005).
“This is a turning point in how we treat EGFR-mutated lung cancer,” said James Chih-Hsin Yang, director, National Taiwan University Cancer Center, Taipei, Taiwan, and lead author on the NEJM manuscript.
“We’re now seeing the potential for patients to live significantly longer than we thought possible. Starting with RYBREVANT and LAZCLUZE may prevent common types of resistance and reserves chemotherapy for later lines of therapy, which can help achieve the best possible outcomes.”
Through the triple mode of action, which includes targeting EGFR mutations from two angles, blocking MET, and engaging the immune system, the combination of RYBREVANT and LAZCLUZE has the potential to change the natural history of the disease by reducing the spectrum and complexity of acquired resistance mechanisms.
“We’re changing the trajectory of this disease,” said Joshua Bauml, vice president, disease area leader, lung cancer, Johnson & Johnson Innovative Medicine.
“Patients with EGFR-mutated lung cancer have waited too long for meaningful progress. Now, we’re delivering survival outcomes that raise expectations and redefine what first-line treatment can achieve.”
The safety profile of RYBREVANT plus LAZCLUZE was consistent with the primary analysis and no new safety signals emerged with longer-term follow-up. Most AEs (grade 3 or higher) occurred early in treatment. RYBREVANT studies suggest that using prophylactic measures can help lower the risk of skin reactions, infusion-related reactions and venous thromboembolic events.
Johnson & Johnson presented the overall survival results at the European Lung Cancer Congress (ELCC) 2025 in Paris.
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.
