RYBREVANT^®▼(amivantamab) in combination with carboplatin and pemetrexed is accepted for use within NHS Scotland as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations

High Wycombe, UK (8 December 2025) – Johnson & Johnson welcomes the decision made today by the Scottish Medicines Consortium (SMC) to accept RYBREVANT^®▼ (amivantamab) in combination with carboplatin and pemetrexed for use within NHS Scotland for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.¹

Lung cancer is the third most common cancer in Scotland, with around 5,300 people diagnosed each year, and NSCLC accounts for 80-85 percent of all cases^2,3 EGFR exon 20 insertion mutations are associated with poorer outcomes compared to other more common EGFR mutations.¹ There has been a significant unmet need for new, targeted treatment options for this group of patients, whose cancer is often resistant to other NSCLC treatments.^1,4

“EGFR+ UK is delighted that the Scottish Medicines Consortium has approved amivantamab with chemotherapy for eligible patients in Scotland diagnosed with EGFR Exon 20 insertion mutations NSCLC,” said Prof. Virginia Harrison, Research Trustee, EGFR+ UK.* “This announcement marks a landmark moment for a group of patients who have long faced limited and often ineffective treatment options. Today’s decision changes that. It gives eligible patients and families a treatment option that truly targets their cancer from day one. This is an important and emotional moment for the patient community, and we’re really grateful to everyone who helped make this progress possible.”

This milestone marks important progress in ensuring that adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations are offered treatment pathways that reflect the underlying biology of their disease.

“The approval is very welcome news and an important advance in the treatment of patients with lung cancer in Scotland. This is the first targeted therapy available in Scotland specifically approved as a first-line treatment for patients with this uncommon subtype of lung cancer, where treatment options until now have been quite limited,” said Dr. Brian Clark, Consultant Clinical Oncologist in Scotland. 

The SMC’s recommendation is based on data from the Phase 3 PAPILLON study, which found that amivantamab with carboplatin and pemetrexed increased median progression-free survival (PFS) by blinded independent committee review (BICR) – the study’s primary endpoint – by 4.7 months (11.4 months versus 6.7 months) compared to carboplatin and pemetrexed alone.^1,4 In the dataset of amivantamab in combination with carboplatin and pemetrexed (N=301), the most frequent adverse reactions in all grades were rash (83 percent, neutropenia (57 percent), nail toxicity (53 percent), infusion related reactions (IRR) (51 percent), fatigue (43 percent), stomatitis (39 percent), nausea (43 percent), thrombocytopenia (40 percent), constipation (40 percent), oedema (40 percent), decreased appetite (33 percent), hypoalbuminaemia (32 percent), alanine aminotransferase increased (26 percent), aspartate aminotransferase increased (23 percent), vomiting (22 percent), and hypokalaemia (20 percent).⁵ Serious adverse reactions included rash (2.7 percent), venous thromboembolism (2.3 percent), thrombocytopenia (2.3 percent) and interstitial lung disease (ILD) (2.0 percent).⁵ 8 percent of patients discontinued amivantamab due to adverse reactions. The most frequent adverse reactions leading to treatment discontinuation were IRR (2.7 percent), rash (2.3 percent), ILD (2.3 percent), and nail toxicity (1.0 percent).⁵

“The availability of targeted treatment options is crucial for people living with lung cancer driven by specific mutations. We are therefore delighted to have secured access for eligible patients in Scotland to a first-line treatment targeting EGFR exon 20 insertion mutations, which will make a real difference to these patients’ lives,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “We are grateful to all involved in the appraisal that led to this positive outcome, and remain committed to partnering with NHS Scotland to ensure swift access for eligible patients.”

#ENDS#

About the PAPILLON study⁴
PAPILLON is a registrational, randomised, open-label, multicentre Phase 3 trial comparing amivantamab with chemotherapy (carboplatin and pemetrexed) versus chemotherapy alone (carboplatin and pemetrexed) in people with untreated, locally advanced or metastatic NSCLC with activating EGFR exon 20 insertion mutations. The primary endpoint of the study was PFS (using RECIST v1.1 guidelines) as assessed by blinded independent central review (BICR). Key secondary outcomes were objective response, overall survival (OS), response duration, time to subsequent therapy, PFS after first subsequent therapy, symptomatic PFS, and safety.

The median PFS by BICR was 11.4 months (95 percent confidence interval [CI], 9.8 to 13.7) in the amivantamab-chemotherapy group and 6.7 months (95 percent CI, 5.6 to 7.3) in the chemotherapy group (hazard ratio for disease progression or death, 0.40; 95 percent CI, 0.30 to 0.53; P<0.001). At 18 months, PFS was reported in 31 percent of the patients in the amivantamab-chemotherapy group and in 3 percent of those in the chemotherapy group. The investigator-assessed PFS was 12.9 months (95 percent CI, 11.4 to 16.7) with amivantamab-chemotherapy and 6.9 months (95 percent CI, 6.2 to 8.3) with chemotherapy (hazard ratio for disease progression or death, 0.38; 95 percent CI, 0.29 to 0.51).

An objective response (complete or partial response) was reported in 73 percent of the patients (95 percent CI, 65 to 80) in the amivantamab-chemotherapy group and in 47 percent (95 percent CI, 39 to 56) of those in the chemotherapy group (rate ratio, 1.50; 95 percent CI, 1.32 to 1.68; P^†<0.001). Although the number of deaths in the trial was too few to provide robust conclusions, the interim OS analysis (at 33 percent data maturity) showed evidence of improved survival with first-line amivantamab-chemotherapy despite a high frequency of crossover to second-line amivantamab monotherapy in the chemotherapy group upon confirmed disease progression. The hazard ratio for death for amivantamab–chemotherapy as compared with chemotherapy was 0.67 (95 percent CI, 0.42 to 1.09; P = 0.11). A final OS analysis is planned at approximately 48 months after the first patient underwent randomisation once the study reaches maturity, with 210 deaths during the trial period.

In the dataset of amivantamab in combination with carboplatin and pemetrexed (N=301), the most frequent adverse reactions in all grades were rash (83 percent), neutropenia (57 percent), nail toxicity (53 percent), infusion related reactions (51 percent), fatigue (43 percent), stomatitis (39 percent), nausea (43 percent), thrombocytopenia (40 percent), constipation (40 percent), oedema (40 percent), decreased appetite (33 percent), hypoalbuminaemia (32 percent), alanine aminotransferase increased (26 percent), aspartate aminotransferase increased (23 percent), vomiting (22 percent), and hypokalaemia (20 percent). Serious adverse reactions included rash (2.7 percent), venous thromboembolism (2.3 percent), thrombocytopenia (2.3 percent) and ILD (2.0 percent). Eight percent of patients discontinued amivantamab due to adverse reactions. The most frequent adverse reactions leading to treatment discontinuation were IRR (2.7 percent), rash (2.3 percent), ILD (2.3 percent), and nail toxicity (1.0 percent).⁵

About amivantamab
Amivantamab is a fully human bispecific antibody which targets both, EGFR and mesenchymal-epithelial transition (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.^1,2,3,4

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.5

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.¹⁰

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 85 percent of all lung cancers.^1,3 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.¹¹ Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.^11,12 EGFR mutations are present in around 15 percent of European patients with NSCLC with adenocarcinoma histology and occur in 40-50 percent of Asian patients.^13,14,15,16 EGFR exon 20 insertion mutations occur in an estimated 12 percent of all EGFR mutation-positive NSCLC cases.¹⁷

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.

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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. 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 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 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 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.

^†For PAPILLON, P-value is from a log-rank test stratified by ECOG PS (0 or 1) and history of brain metastases (yes or no).

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