NICE issues Final Draft Guidance recommending that RYBREVANT^®▼ (amivantamab) with carboplatin and pemetrexed can be used during a managed access period for untreated advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults

High Wycombe, UK (8 May 2026) – Johnson & Johnson is pleased to announce today that the National Institute for Health and Care Excellence (NICE) has recommended that RYBREVANT^®▼ (amivantamab) with carboplatin and pemetrexed can be used during a managed access period for untreated advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults, in its Final Draft Guidance.¹ This recommendation means that eligible patients in England and Wales may soon be treated with amivantamab in combination with carboplatin and pemetrexed on the National Health Service (NHS) via the Cancer Drugs Fund.¹

In England and Wales, more than 41,000 people were diagnosed with lung cancer in 2024.² NSCLC is the most common type of lung cancer, accounting for 80-85 percent of all cases.³ Patients diagnosed with EGFR exon 20 insertion mutation-positive NSCLC are more likely to experience poorer prognoses and outcomes compared to other types of NSCLC with more common EGFR mutations, such as exon 19 deletions and exon 21 L858R substitution mutations.^1,4,5 EGFR exon 20 insertion mutations are also more likely to occur in women, people from Asian ethnicities, and people with no history of smoking.¹ There has long been a significant unmet need for targeted treatment options for this group of patients.¹ EGFR exon 20 insertion mutated NSCLC is largely insensitive to tyrosine kinase inhibitors that have been approved for the treatment of patients with common EGFR-mutated NSCLC.^1,5

“This is a hugely important moment and marks a significant shift in care for people living with EGFR exon 20 insertion mutated non-small cell lung cancer, a group that has historically been overlooked and underserved,” said Prof. Virginia Harrison, Research Trustee, EGFR+ UK*. “Too often, people with exon 20 insertion mutations have faced limited options compared to other EGFR subtypes, such as EGFR exon 19 deletions or exon 21 L858R substitution mutations. This decision has the potential to address that inequity and ensure patients finally have access to targeted therapies designed specifically for their disease.”

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

“This is a landmark moment for patients with EGFR exon 20 insertion-mutant lung cancer in the UK, a historically underserved group who have had limited access to targeted therapy. The NICE recommendation of amivantamab in combination with chemotherapy changes that entirely. We can now offer patients with this difficult-to-treat mutation a targeted treatment that addresses the biology driving their cancer, now available to NHS patients through the Cancer Drugs Fund. This recommendation will make a real difference to the lives of patients who have waited far too long,” said Dr Spyros Gennatas, Consultant Medical Oncologist, Guy’s and St Thomas’ NHS Foundation Trust^†.

NICE’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.^1,5 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).⁶ 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).⁶ Eight percent of patients discontinued amivantamab due to adverse reactions.⁶ 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).⁶

“We are delighted with NICE’s Final Draft Guidance which means that eligible patients in England and Wales with EGFR exon 20 insertion mutation-positive advanced NSCLC will soon have access through the Cancer Drugs Fund to a targeted therapy that addresses their specific type of cancer. The availability of this targeted treatment is crucial as we seek to make a real difference to these patients’ lives from day one,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “We are committed to getting in front of cancer, and will work closely with partners across the healthcare system to ensure today’s positive announcement translates into timely and equitable uptake across the NHS. Thank you to everyone who contributed to the appraisal process.”

#ENDS#

About the PAPILLON study⁵
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).⁶ Serious adverse reactions included rash (2.7 percent), venous thromboembolism (2.3 percent), thrombocytopenia (2.3 percent) and ILD (2.0 percent).⁶ Eight percent of patients discontinued amivantamab due to adverse reactions.⁶ 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).⁶

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.^7,8,9,10

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.⁶

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.¹¹

About NSCLC
Lung cancer is the third most commonly diagnosed cancer in the UK, and a leading cause of cancer deaths.¹² NSCLC is the most common type, accounting for 80-85 percent of all lung cancer types.³ The 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.^13,14 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.^15,16,17,18 EGFR exon 20 insertion mutations occur in an estimated 12 percent of all EGFR mutation-positive NSCLC cases.¹⁹

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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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.

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

^†Dr Spyros Gennatas has served as a consultant to Johnson & Johnson; they have not been paid for any media work.

^‡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).