Janssen-Cilag International NV, a Johnson & Johnson company,  announced new longer follow-up data from the landmark Phase 3 MARIPOSA study. These results confirm that first-line treatment with RYBREVANT® (amivantamab) in combination with lazertinib provides superior long-term outcomes compared to osimertinib monotherapy in adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. The data show a strong and improving overall survival (OS) trend favoring the amivantamab plus lazertinib combination at approximately three years of follow-up. These findings were presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC) in San Diego, California (Abstract #1146).

At three years (median follow-up of 31.1 months), 61% of patients receiving the amivantamab-lazertinib combination were alive compared to 53% of patients treated with osimertinib (Median OS not estimable [NE] vs 37.3 months; hazard ratio [HR]=0.77; 95% confidence interval [CI], 0.61-0.96; nominal P=0.019). Progression-free survival (PFS) remained the primary endpoint of the study, assessed by blinded independent central review (BICR).

“By combining the multi-targeted mechanism of amivantamab with lazertinib, we are advancing a chemotherapy-free regimen for patients with EGFR-mutant NSCLC, offering prolonged benefits,” said Dr. Shirish M. Gadgeel, presenting author and Chief of Division of Hematology and Oncology at Henry Ford Cancer Institute. “The data show an eight percent survival improvement at three years for the combination compared to osimertinib, highlighting its potential as a first-line treatment option.”

The study also showed a trend towards improved central nervous system (CNS) disease control with the combination therapy compared to osimertinib (HR=0.82). Additionally, more patients on the combination therapy remained on treatment at three years (40% vs 29%) and had not started a subsequent therapy (45% vs 32%).

“At Johnson & Johnson, we are committed to improving outcomes in lung cancer, and these MARIPOSA study results reinforce the potential of amivantamab and lazertinib as a first-line therapy,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine.

The safety profile of amivantamab plus lazertinib was consistent with prior studies, with low discontinuation rates due to treatment-related adverse events.