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 a projected improvement of more than one year versus osimertinib¹

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 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

#ENDS#

About the MARIPOSA study
MARIPOSA is a randomised, open-label, active-controlled, multicentre phase 3 study assessing the efficacy and safety of lazertinib in combination with amivantamab compared to osimertinib monotherapy in the first-line treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with exon 19 deletion or exon 21 L858R substitution mutations.⁴ The primary endpoint of this study was PFS, with secondary endpoints being OS, objective response (OR), duration of response (DOR) and safety.⁴

About amivantamab
Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistant EGFR mutations and MET mutations and amplifications, and by harnessing the immune system.^5,6,7,8 Amivantamab is licensed for treating adults in Great Britain and Northern Ireland in combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.⁹

Adverse events should be reported. ▼ This medicinal product is subject to additional monitoring, and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited, a Johnson & Johnson company on 01494 567447 or at [email protected].

About lazertinib
In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Lazertinib is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.³ An analysis of the efficacy and safety of Lazertinib from the Phase 3 study LASER301 was published in The Journal of Clinical Oncology in 2023.³

Adverse events should be reported. ▼ This medicinal product is subject to additional monitoring, and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited, a Johnson & Johnson company on 01494 567447 or at [email protected].

About non-small cell lung cancer
Lung cancer is the third most common cancer in the UK, and it is estimated that there are around 49,200 new lung cancer cases in the UK every year (2017-2019).¹⁰ Non-small cell lung cancer (NSCLC) is the most common type, accounting for 80-85 percent of all lung cancers.¹¹

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.¹² Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.^12,13 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.^1415,16,17 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations.¹⁴ The five-year survival rate for patients with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.¹⁸

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://innovativemedicine.jnj.com/uk/.

Follow us at https://www.linkedin.com/company/jnjinnovativemedicineuk/ and www.x.com/JNJInnovMedUK.

© Janssen-Cilag Limited, a Johnson & Johnson Company. All rights reserved.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab and lazertinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag Limited and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. Janssen-Cilag Limited nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

^{*Based on an exponential distribution assumption of OS in both arms, the improvement in median OS is predicted to exceed 1 year.}

^{** Professor Nicolas Girard has served as a consultant to Johnson & Johnson; he has not been paid for any media work.}

^{†P-value is calculated by log-rank test stratified by mutation type (Ex19del or L858R), race (Asian or Non-Asian), and history of brain metastasis (present or absent).}