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RYBREVANT (amivantamab) plus LAZCLUZE (lazertinib) demonstrates significant overall survival benefit in patients with EGFR-mutated advanced non-small cell lung cancer versus osimertinib

March 26, 2025 – Biotechnology, Clinical Trials, Other, Pharmaceutical – Janssen, Johnson & Johnson, Johnson & Johnson Innovative Medicine, NSCLC, clinical trials, oncology

Median overall survival not yet reached with a projected improvement of more than one year versus osimertinib

26 March 2025 — Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT^®▼(amivantamab) plus LAZCLUZE^®▼(lazertinib) significantly extended OS 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. Median OS is projected to exceed one year beyond the median of three years observed with osimertinib, and has not yet been reached. This is the first study to show a statistically significant and clinically meaningful OS improvement versus osimertinib. These new data were presented during a proffered paper 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.”

Unlike progression-free survival (PFS), which tracks the time a treatment keeps a patient’s cancer from progressing, overall survival may help patients understand the impact therapy could have on the ability to live longer from the start of treatment. Extending life expectancy is the most meaningful indicator of a treatment’s impact.

“We are committed to redefining the standard of care for people living with lung cancer and are excited to be at a point where that is becoming a reality,” said Henar Hevia, PhD., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “The overall survival results from the MARIPOSA study reinforce the potential life-changing impact the chemotherapy-free combination of amivantamab and lazertinib can have for patients and their loved ones, when used in the first-line setting.”

At a median follow-up of 37.8 months, patients treated with first-line amivantamab plus lazertinib had a significantly longer overall survival compared to those receiving osimertinib (hazard ratio [HR], 0.75; 95 percent Confidence Interval [CI], 0.61-0.92; nominal P<0.005^†). 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). Comparatively, median OS for osimertinib-treated patients was 36.7 months (95 percent CI, 33.4-41.0) and consistent with prior studies with osimertinib. Fifty-six percent of patients treated with amivantamab and lazertinib were alive at three and a half years compared to 44 percent of patients on osimertinib, the current standard of care. Projections based on survival data suggest amivantamab plus lazertinib could extend median OS by at least 12 months compared to osimertinib.

The amivantamab plus lazertinib combination also prolonged multiple secondary endpoints vs osimertinib, including intracranial PFS, intracranial duration of response and intracranial overall response rate. Notably, amivantamab plus lazertinib prolonged time to symptomatic progression (TTSP) – 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 vs 29.3 months; HR, 0.69;95 percent CI, 0.57-0.83; nominal P<0.001^†). This is a key patient-centered measure, highlighting how long quality of life can be preserved before lung cancer symptoms further impact patient care.

“Right now, approximately twenty percent of patients with EGFR-mutated advanced NSCLC survive beyond five years. These MARIPOSA results suggest that amivantamab plus lazertinib can help change this statistic,” said Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “By using this regimen in first-line treatment, we’re offering the potential to delay the need for chemotherapy and give patients and their families hope for more time.”

The safety profile of amivantamab plus lazertinib was consistent with the primary analysis, with treatment emergent adverse event (TEAE) rates comparable to other amivantamab regimens. No new safety signals were identified with the additional longer-term follow-up. The most common TEAEs of any grade that occurred were paronychia (69 percent), infusion-related reaction (65 percent), and rash (64 percent). Amivantamab plus lazertinib had higher rates of EGFR- and MET-related TEAEs compared to osimertinib, except diarrhoea, for which rates were higher for osimertinib. The most common Grade 3 or higher adverse events (AEs) were rash (17 percent), paronychia (12 percent), dermatitis acneiform (9 percent) and alanine transaminase increase (7 percent). Most AEs occurred early during amivantamab and lazertinib treatment. Findings from other studies with amivantamab suggest that implementing prophylactic measures during the first four months of amivantamab and lazertinib treatment may significantly reduce the risk of skin reactions, infusion-related reactions and venous thromboembolic events.

The MARIPOSA study met its primary endpoint in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib. Amivantamab plus lazertinib is approved in the European Union for the first-line treatment of patients with advanced common EGFR-mutated NSCLC. These OS results will be shared with health authorities globally.

About Johnson & Johnson

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