RYBREVANT®▼ (amivantamab) plus LAZCLUZE®▼ (lazertinib) demonstrates significant overall survival benefit in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations versus osimertinib

Median overall survival not yet reached with an expected improvement of more than one year versus osimertinib^[1]

High Wycombe, UK (27 March 2025) – Johnson & Johnson (J&J)  announced results from its first-line MARIPOSA trial, which showed RYBREVANT^®▼(amivantamab), plus LAZCLUZE^®▼(lazertinib) significantly extended overall survival (OS) versus osimertinib in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.^1,[2] Median OS is projected to exceed one year* beyond the median of three years observed with osimertinib, and has not yet been reached.¹ These new data were presented during a poster session at the 2025 European Lung Cancer Congress (ELCC) (Abstract #4O).

“The survival curve demonstrates that amivantamab plus lazertinib can help patients live longer compared to osimertinib monotherapy, and suggests the benefit keeps growing over time,” said trial investigator Professor Nicolas Girard**, M.D., Ph.D., Head of Medical Oncology, Institut Curie, and Professor of Thoracic Oncology and Respiratory Medicine at the Paris Saclay University, France. “We see the gap between the survival curves continue to widen, which is exactly what we want to see in lung cancer treatment to improve outcomes for patients. These results reinforce that we are entering a new era for EGFR-mutated advanced non-small cell lung cancer.”

“J&J is committed to getting in front of cancer and redefining the standard of care for people living with lung cancer, and our first line study results bring us closer to making that a reality,” said Dr John Fleming, Country Medical Director UK, Johnson & Johnson Innovative Medicine. “To give people living with lung cancer more time to spend with their loved ones, it’s vital we continue pushing the boundaries of innovation.”

At a median follow-up of 37.8 months, patients treated with first-line amivantamab plus lazertinib had a significantly longer OS compared to those receiving the current standard of care, osimertinib (hazard ratio [HR], 0.75; 95 percent Confidence Interval [CI], 0.61-0.92; P<0.005).¹ Median OS for amivantamab plus lazertinib has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period (Not Reached [NR]; 95 percent CI, 42.9-NR).¹ Comparatively, median OS for osimertinib-treated patients was 36.7 months (95 percent CI, 33.4-41.0).¹ 56 percent of patients treated with amivantamab and lazertinib were alive at three and a half years compared to 44 percent of patients on osimertinib.¹ Projections based on survival data suggest amivantamab plus lazertinib could extend median OS by at least 12 months compared to osimertinib.^*1

The amivantamab plus lazertinib combination also prolonged multiple secondary endpoints versus osimertinib including intracranial PFS, duration of response and overall response rate.¹ Notably, amivantamab plus lazertinib prolonged time to symptomatic progression – the time from treatment randomisation to the onset of new or worsening lung cancer symptoms requiring intervention – by more than 14 months compared to osimertinib (43.6 months versus 29.3 months; HR, 0.69; 95 percent CI, 0.57-0.83; P<0.001^†).¹

The safety profile of amivantamab plus lazertinib was consistent with the primary analysis.¹ No new safety signals were identified with the additional longer-term follow-up.¹ The most common TEAEs of any grade that occurred were paronychia (69 percent), infusion-related reaction (65 percent), and rash (64 percent).¹ Amivantamab plus lazertinib had higher rates of EGFR- and mesenchymal-epithelial transition (MET)-related TEAEs compared to osimertinib, except diarrhoea, for which rates were higher for osimertinib.¹ The most common Grade 3 or higher adverse events (AEs) were rash (17 percent), paronychia (12 percent), dermatitis acneiform (nine percent) and alanine transaminase increase (seven percent).¹ Most AEs occurred early during amivantamab and lazertinib treatment.¹

The MARIPOSA study met its primary endpoint in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib.^[3] 

Amivantamab plus lazertinib received marketing authorisation in the UK for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.²

[1] Yang J, et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line (1L) EGFR-mutant (EGFRm) Advanced NSCLC: Final Overall Survival (OS) from the Phase 3 MARIPOSA Study. 2025 European Lung Cancer Congress. March 26, 2025.

[2] Medicines and Healthcare products Regulatory Agency. Lazcluze Summary of Product Characteristics. Available at https://mhraproducts4853.blob.core.windows.net/docs/03ab672c72b80a733b9ff2b0d79343b905842afc. Last accessed March 2025.

[3] Cho BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217.