AstraZeneca’s Tagrisso (osimertinib) has been accepted for restricted use within NHS Scotland by the Scottish Medicines Consortium (SMC) for the treatment of early-stage lung cancer.
Osimertinib will be used as monotherapy for the adjuvant treatment after complete tumour resection in adult patients 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.1 Treatment with osimertinib is subject to a three-year clinical stopping rule.1
Lung cancer accounts for a quarter of all cancer deaths in Scotland, with NSCLC being the most common form of the disease. For patients diagnosed with early-stage lung cancer, standard treatment is surgery with curative intent, followed by adjuvant chemotherapy in appropriate patients. Despite this, 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
Dr Brian Clark, Consultant Clinical Oncologist at Beatson West of Scotland Cancer Centre, said: “This is a rare type of lung cancer that typically affects younger patients and non-smokers, and often does not respond as well to other treatment options. In a landmark clinical trial, those patients who received osimertinib after surgery had a substantially reduced risk of their cancer coming back. Scotland is the first country in the world to approve the routine use of osimertinib in this setting, which is very exciting.”
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 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
AstraZeneca estimates that approximately 25 patients in Scotland with early-stage NSCLC will be eligible for targeted therapy with osimertinib every year.
The SMC is reportedly the first organisation to complete a health technology appraisal for osimertinib in this setting. It follows a decision by the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2021 to grant a license extension for osimertinib in this indication in Great Britain.
Tom Keith-Roach, President of AstraZeneca UK, said: “Today’s SMC decision is welcome news aligned to the Scottish Government and NHS’s stated commitment to cancer as a national clinical priority. The ADAURA trial was unblinded early due to overwhelming efficacy just 18 months ago and today’s decision is a great example of collaboration between industry, regulators and the health system bringing breakthrough innovation to UK patients as quickly as possible.”
Image credit: Robina Weermeijer
References
- Pignon JP, Tribodet H, Scagliotti GV, et al. Lung Adjuvant Cisplatin Evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.
- Tagrisso (osimertinib). Summary of Product Characteristics. 6 May 2021. Available at: https://www.medicines.org.uk/emc/product/1985/smpc#gref. Last accessed: November 2021.
- Wu YL, Tsuboi M, He J, et al. Osimertinib in resected EGFR-mutated non–small-cell lung cancer. N Engl J Med. 2020;383:1711-1723.
