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

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 per cent of all cases.^[3] EGFR mutations are present in around 5-37 per cent of cases of NSCLC in European patients, and most (85-90 per cent) 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 per cent confidence interval [CI], 19.1 to 27.7) without their disease worsening versus 16.6 months (95 per cent CI, 14.8 to 18.5) in patients receiving osimertinib alone (hazard ratio [HR] for disease progression or death, 0.70; 95 per cent 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 per cent 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 per cent CI, 42.9-not reached [NR]) in patients treated with the combination versus 36.7 months (95 per cent CI, 33.4-41.0) for patients treated with osimertinib alone.⁷ At the data cut‑off, approximately 60 per cent of patients receiving amivantamab with lazertinib were alive, compared with 51 per cent 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 per cent patients) were rash (87 per cent), nail toxicity (67 per cent), hypoalbuminaemia (48 per cent), hepatotoxicity (43 per cent), stomatitis (43 per cent), oedema (42 per cent), fatigue (35 per cent), paraesthesia (29 per cent), constipation (26 per cent), diarrhoea (26 per cent), dry skin (25 per cent), decreased appetite (24 per cent), nausea (24 per cent), and pruritus (23 per cent).^[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 (pictured), 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.”