The National Institute for Health and Care Excellence has issued Final Draft Guidance recommending amivantamab in combination with lazertinib as a first-line treatment for adults with untreated advanced non-small cell lung cancer whose tumours harbour epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations.

The recommendation applies within the combination’s marketing authorisation and means newly diagnosed eligible patients can now access the chemotherapy-free regimen on the NHS in England and Wales. Non-small cell lung cancer accounts for around 80 to 85 percent of all lung cancer cases, and EGFR mutations are present in approximately 15 percent of European patients, with the majority involving exon 19 deletions or exon 21 L858R substitutions.

Between 2019 and 2023, around 35,000 people were diagnosed with lung cancer each year in England. EGFR-mutated disease is more common in women than men, in people who do not smoke and in those from Asian ethnic groups, underlining the importance of targeted first-line options that reflect different patient needs.

Patient advocacy group EGFR+ UK welcomed the decision, highlighting the value of increased choice at diagnosis. Prof Virginia Harrison, research trustee at EGFR+ UK, said: “This is a meaningful advance for patients and their families facing this diagnosis. Importantly, it also provides something the EGFR community urgently needs: more choice in first-line treatment.”

She added that broader access to treatment options allows care to be better tailored to individuals, while also supporting outcomes and patient experience across the pathway.

Clinicians also pointed to the flexibility the guidance brings to NHS practice. Professor Sanjay Popat, medical oncologist at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, said: “Access to additional first-line options on the NHS gives clinicians the flexibility to individualise treatment plans, which is essential in addressing the complex needs of this patient population.”

The NICE recommendation is based on data from the Phase 3 Mariposa study. The trial met its primary endpoint of progression free survival, with patients treated with amivantamab and lazertinib achieving a median progression free survival of 23.7 months compared with 16.6 months for those receiving osimertinib. The hazard ratio for disease progression or death was 0.70, with a statistically significant p value of less than 0.001.

Overall survival, a secondary endpoint, was also significantly improved for patients receiving the combination. Median overall survival has not yet been reached in the amivantamab and lazertinib arm, compared with 36.7 months for patients treated with osimertinib.

Safety data from the amivantamab and lazertinib dataset, which included 752 patients receiving either intravenous or subcutaneous formulations of amivantamab, showed the most frequent adverse reactions were rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, stomatitis, oedema and fatigue, alongside gastrointestinal and skin-related events.

Johnson & Johnson said the guidance represents progress for patient access to innovation within the NHS. Amanda Cunnington, UK senior director of patient access at Johnson & Johnson Innovative Medicine, said: “The availability of a chemotherapy-free combination treatment will no doubt be welcome news to eligible patients and their loved ones.”

She added that the company would continue to work with healthcare partners to support equitable and timely access to new therapies, and to enable clinicians to deliver more personalised care for people with EGFR-mutated advanced lung cancer.