RYBREVANT^®▼ (amivantamab) with LAZCLUZE™▼ (lazertinib) is accepted for use within NHS Scotland as a first-line treatment for adult patients with untreated advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations

The combination therapy offers a chemotherapy-free option for eligible patients¹

High Wycombe, UK (11 May 2026) – Johnson & Johnson welcomes the decision made today by the Scottish Medicines Consortium (SMC) to accept RYBREVANT^®▼ (amivantamab) with LAZCLUZE™▼ (lazertinib), for use within the National Health Service (NHS) Scotland for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in previously untreated adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.¹ This recommendation means that newly-diagnosed eligible patients may now be treated with amivantamab and lazertinib on the NHS in Scotland.¹

Lung cancer is the third most common cancer in Scotland, with around 5,300 people diagnosed each year.² NSCLC is the most common type of lung cancer, accounting for 80-85 percent of all cases.³ EGFR mutations are present in around 5-37 percent of cases of NSCLC in European patients, and most (85-90 percent) are exon 19 deletions or exon 21 L858R substitution mutations.^4,5,6 EGFR-positive NSCLC is more common in women than in men, those who do not smoke and people from Asian ethnic groups.⁵

“EGFR+ UK warmly welcomes the decision by the Scottish Medicines Consortium to approve amivantamab in combination with lazertinib,” said Prof. Virginia Harrison, Research Trustee, EGFR+ UK*. “For people living with common EGFR mutated non-small cell lung cancer, innovation in first-line treatment is critical. For our community, this decision is an important step forward and underlines the importance of ensuring patients across the UK can benefit from advances in targeted therapies.”

“The approval of this first-line targeted therapy option is good news for eligible patients in Scotland with common EGFR mutations positive lung cancer,” said Dr Nicola Steele, Consultant Medical Oncologist, NHS Scotland^†. “It offers patients and their doctors an alternative to chemotherapy containing regimens, meaning we can use a more tailored approach. By having a choice of initial treatment, patients can make shared decisions with their doctors regarding which option is suited to their medical needs and lifestyle.”

The SMC’s acceptance is based on data from the Phase 3 MARIPOSA study, which met its primary endpoint of progression free survival (PFS), with patients receiving amivantamab with lazertinib living for a median of 23.7 months (95 percent confidence interval [CI], 19.1 to 27.7) without their disease worsening versus 16.6 months (95 percent CI, 14.8 to 18.5) in patients receiving osimertinib alone (hazard ratio [HR] for disease progression or death, 0.70; 95 percent CI, 0.58-0.85; p<0.001^‡).⁷ Additionally, patients receiving amivantamab with lazertinib experienced significantly improved overall survival (OS) [secondary endpoint] versus those who received osimertinib alone (HR for death, 0.75; 95 percent CI, 0.61-0.92; p<0.005).⁷ Median OS, at a median follow up of 37.8 months, had not yet been reached (95 percent CI, 42.9-not reached [NR]) in patients treated with the combination versus 36.7 months (95 percent CI, 33.4-41.0) for patients treated with osimertinib alone.⁷ At the data cut‑off, approximately 60 percent of patients receiving amivantamab with lazertinib were alive, compared with 51 percent of patients receiving osimertinib monotherapy.⁷

In the dataset of amivantamab (either intravenous or subcutaneous formulations) in combination with lazertinib (N=752), the most frequent adverse reactions of any grade (≥ 20 percent patients) were rash (87 percent), nail toxicity (67 percent), hypoalbuminaemia (48 percent), hepatotoxicity (43 percent), stomatitis (43 percent), oedema (42 percent), fatigue (35 percent), paraesthesia (29 percent), constipation (26 percent), diarrhoea (26 percent), dry skin (25 percent), decreased appetite (24 percent), nausea (24 percent), and pruritus (23 percent).⁸

“We welcome the SMC’s announcement, which means eligible patients in Scotland will soon have access to an additional chemotherapy-free first-line treatment option,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “This outcome supports flexibility in treatment decision-making and is a positive milestone for the lung cancer community. We remain committed to partnering with NHS Scotland to ensure this acceptance translates into timely and equitable access, enabling tailored disease management approaches to reach the patients who need them.”

#ENDS#

About the MARIPOSA study
MARIPOSA is a randomised-controlled, open-label, multicentre Phase 3 study assessing the efficacy and safety of amivantamab in combination with lazertinib 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 mutation.^6,7 The primary endpoint was PFS, and key secondary endpoints included OS, objective response (OR), duration of response (DOR) and safety.⁶

The amivantamab with lazertinib combination also met other secondary endpoints versus osimertinib.⁷ Amivantamab with 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 alone (43.6 months versus 29.3 months; HR, 0.69; 95 percent CI, 0.57-0.83; p<0.001^‡).⁷ Intra-cranial PFS (icPFS) was not met – with 37.8 months median follow-up, the median icPFS for amivantamab with lazertinib was 25.4 months compared to osimertinib, which was 22.2 months (HR, 0.79; 95 percent CI, 0.61-1.02; p=0.07).⁷ Patients who received amivantamab with lazertinib also demonstrated greater intra-cranial durability of response (icDoR) than compared with osimertinib alone (35.7 months [95% CI, 25.8-NR] versus 29.6 months [95% CI, 23.9-34.1]), with a median follow-up of 37.8 months.⁷

Most adverse events were related to EGFR inhibition (e.g., paronychia and rash) and mesenchymal-epithelial transition (MET) inhibition (e.g., hypoalbuminemia and peripheral oedema). At least one adverse event of grade 3 or higher occurred in 80 percent of the participants in the amivantamab and lazertinib group and in 52 percent of those in the osimertinib group. Key adverse events first occurred during the 4-month period after randomisation, with longer follow-up showing no new safety signals. Serious adverse events were reported in 55 percent of the participants in the amivantamab and lazertinib group and in 41 percent of those in the osimertinib group. Venous thromboembolism (a grouped term that included pulmonary embolism, deep-vein thrombosis, and thrombosis, among other conditions) occurred in 40 percent of the participants in the amivantamab and lazertinib group and in 11 percent of those in the osimertinib group. As previously reported, few participants (5 percent) were receiving anticoagulation therapy at baseline. ⁷

Serious adverse reactions
Serious adverse reactions were reported in 14 percent of patients who received amivantamab subcutaneous formulation in combination with lazertinib, including interstitial lung disease (ILD) (4.2 percent), venous thromboembolic (VTE) (2.7 percent), hepatotoxicity (2.1 percent), and fatigue (1.5 percent).⁸ Seven percent of patients discontinued amivantamab subcutaneous formulation due to adverse reactions.⁸ In patients treated with amivantamab subcutaneous formulation in combination with lazertinib, the most frequent adverse reactions of any grade (≥ 1 percent patients) leading to discontinuation of amivantamab subcutaneous formulation were ILD (3.6 percent) and rash (1.5 percent).⁸

The most frequent serious adverse reactions reported with the intravenous formulation included VTE (11 percent), ILD (2.9 percent), rash (2.4 percent), and infusion-related reactions (IRR) (2.1 percent).⁹ 22 percent of patients discontinued amivantamab and lazertinib due to adverse reactions.⁹ The most frequent adverse reactions leading to treatment discontinuation were rash (5.5 percent), infusion related reactions (4.5 percent), nail toxicity (3.6 percent), ILD (2.9 percent) and VTE (2.9 percent).⁹ Most adverse events were grade 1 and 2.⁹

About amivantamab
Amivantamab is a fully human bispecific antibody which targets both EGFR and MET. This makes amivantamab the first bispecific antibody targeting tumours with activating and resistant EGFR mutations, and MET mutations and amplifications, addressing two major mechanisms of resistance in NSCLC.^10,11,12,13

In the UK, amivantamab subcutaneous injection is indicated:

• 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;
• as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy.⁸

In the UK, amivantamab intravenous infusion is indicated:

• 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;
• in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI);
• in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations;
• as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy.⁹

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.¹⁴

In the UK, lazertinib in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.¹⁵

About NSCLC
Lung cancer is the third most common cancer in Scotland, with approximately 5,300 new cases diagnosed every year.² NSCLC is the most common type, accounting for 80-85 percent of all lung cancers.³The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.³ Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.^16,17 In some patients with NSCLC, mutations in the gene responsible for EGFR lead to its overexpression.¹⁸ This abnormal activity can cause uncontrolled cell growth, ultimately driving the development and progression of cancer.¹⁶ EGFR mutations are present in around 5-37 percent of European patients with NSCLC with adenocarcinoma histology and occur in 40-50 percent of Asian patients.^4,5,19,20,21 EGFR exon 19 deletion or EGFR L858R mutations are the most common EGFR mutations.²²

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://www.jnj.com/innovativemedicine/uk/

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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 related to 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 materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and 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 most recent Annual Report on Form 10-K, 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, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

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*EGFR+ UK has not been paid for any media work.

^†Dr Nicola Steele has served as a consultant to Johnson & Johnson; she has not been paid for any media work.

^‡P-value is calculated by log-rank test stratified by mutation type (exon 19 deletion or L858R), race (Asian or Non-Asian), and history of brain metastasis (present or absent).