National Institute for Health and Care Excellence (NICE) Issues Positive Recommendation for Tagrisso®⯆(osimertinib) in England for Patients With Early-Stage Lung Cancer

• Osimertinib will be made available via the Cancer Drugs Fund (CDF) to patients in England with completely resected early-stage IB-IIIA EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).¹
• Currently, patients with this type of lung cancer are treated with the intention of cure; however, many relapse because treatment is limited to surgery and adjuvant chemotherapy.²
• Unprecedented data from the ADAURA clinical trial show that osimertnib, the first approved targeted oral therapy in this setting, can reduce the risk of disease recurrence or death (disease-free survival) by 80% in patients with stage IB-IIIA EGFRm NSCLC versus placebo.³

Luton, UK, 30 November 2021 – AstraZeneca today announced that Tagrisso (osimertinib) is now available as an adjuvant treatment option after complete tumour resection in adult patients in England with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations via the Cancer Drugs Fund (CDF).¹ Treatment with osimertinib is subject to a three-year clinical stopping rule.¹ This follows a positive final recommendation from the National Institute for Health and Care Excellence (NICE).

Professor Eric Lim, Professor of Thoracic Surgery at The Royal Brompton Hospital, said: “This is a significant milestone in the treatment of lung cancer in England as there remains an urgent need for new personalised therapies even in early-stage disease that have the potential to improve results of established treatments such as surgery. Data show that osimertinib, a well-tolerated treatment, reduces the risk of cancer recurrence or death by 80% in patients with early-stage EGFR mutation-positive non-small cell lung cancer after a successful operation. It is vital we identify eligible patients with EGFR mutations early in the treatment pathway to ensure they can access this treatment to potentially improve and extend their lives.”

Lung cancer accounts for over one in five (21%) of all cancer deaths in the UK,⁴ and more than 48,000 people in England are diagnosed with NSCLC every year,⁵ with around 12% having tumours with EGFR mutations.⁶ Patients with early-stage NSCLC often undergo surgery with curative intent as standard of care – however, disease recurrence within five years of surgery remains high, and has been reported to occur in 45% of Stage IB, 62% of Stage II, and 76% of Stage III patients.²

Jenny Abbott, co-chair of patient organisation EGFR Positive UK, said: “Early diagnosis, coupled with early preventative treatment, is key to improving long-term survival and we welcome this decision, which means that patients diagnosed in England with early-stage lung cancer will now continue to have access to this important potential life-extending treatment.”

In the ADAURA Phase III trial, adjuvant treatment (after surgery) with osimertinib in patients with stage II-IIIA EGFRm NSCLC reduced the relative risk of disease recurrence or death (disease-free survival) by 83% compared to placebo (HR = 0.17; 99.06% CI, 0.11 to 0.26; P<0.0011).³ Survival without disease recurrence at two years was 90% (95% CI 84-93) for osimertinib and 44% (95% CI 37-51) for placebo.³ When looking at the broader group of patients (stage IB-IIIA) – a secondary endpoint – the percentage of patients who were alive and disease-free at 24 months was 89% (95% CI, 85 to 92) in the osimertinib group and 52% (95% CI, 46 to 58) in the placebo group. The overall hazard ratio for disease recurrence or death was 0.20 (99.12% CI, 0.14 to 0.30; P<0.001), which equates to an 80% risk reduction.³

The announcement follows authorisation of a license extension by the Medicines and Healthcare products Regulatory Agency (MHRA) in May for osimertinib as monotherapy in this indication – the first authorisation issued under Project Orbis; a global programme designed to deliver faster patient access to innovative cancer treatments.⁷ Simultaneously, an agreement was reached with NHS England and NICE to enable early access to osimertinib for patients in England. The NICE recommendation announced today means that patients will continue to be eligible for treatment with osimertinib via the Cancer Drugs Fund.¹

Tom Keith-Roach, President, AstraZeneca UK, said: “The Government’s Life Sciences Vision recognises how integral early diagnosis and rapid access to innovative medicines are for improving outcomes for people with cancer, and the chain of events leading to today’s NICE recommendation is testament to this. From the MHRA, to NICE and NHS England, we welcome the collaborative engagement that has enabled us to bring the first precision medicine for early-stage lung cancer to patients as quickly as possible.”

Arun Krishna, Head of Oncology, AstraZeneca UK, said: “We are delighted with this positive recommendation which builds on the initial early access authorisation achieved through Project Orbis and reaffirms the role that this potentially life-extending treatment can have for some people with early-stage lung cancer. It’s now critical that everyone with non-small cell lung cancer – no matter what stage of disease – is tested for the presence of EGFR mutations to determine whether osimertinib could be a potential treatment option.”

Across the ADAURA, FLAURA and AURA studies for osimertinib, very common adverse reactions included: diarrhoea (47% all grades; 1.4% > grade 3), stomatitis (24% all grades; 0.5% > grade 3), rash (45% all grades; 0.7% > grade 3), dry skin (32% all grades; 0.1% > grade 3), paronychia (33% all grades; 0.4% > grade 3), pruritus (17% all grades; 0.1% > grade 3), platelet count decreased (53% all grades; 1.2% > grade 3), leucocytes decreased (65% all grades; 1.2% > grade 3), lymphocytes decreased (62% all grades; 6.1% > grade 3) and neutrophils decreased (33% all grades; 3.2% > grade 3).⁸ Common adverse reactions included: epistaxis (5.3% all grades; 0 > grade 3), interstitial lung disease (3.7% all grades; 1.1% > grade 3), Palmar-plantar erythrodysaesthesia syndrome (1.7% all grades; 0 > grade 3), alopecia (4.6% all grades; 0 > grade 3), urticaria (1.9% all grades; 0.1% > grade 3) and blood creatinine increased (9.4% all grades; 0 > grade 3).⁸