SMC ACCEPTS TAGRISSO® (osimertinib) FOR USE IN SCOTLAND FOR TREATMENT OF EGFR MUTATED ADVANCED LUNG CANCER

SMC ACCEPTS TAGRISSO^® (osimertinib) FOR USE IN SCOTLAND FOR TREATMENT OF EGFR MUTATED ADVANCED LUNG CANCER

• Scottish Medicines Consortium (SMC) has accepted osimertinib for use as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.[1]
• Osimertinib has been shown to provide a median overall survival of more than three years when used as a first-line treatment for EGFR mutation-positive (EGFRm) NSCLC in clinical trials.[2]

Luton, UK, 17 January 2022 – AstraZeneca today announced that Tagrisso (osimertinib) has been accepted for use within NHS Scotland by the Scottish Medicines Consortium (SMC) as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.1

Lung cancer accounts for a quarter of all cancer deaths in Scotland, with NSCLC being the most common form of the disease.[3] Almost half of lung cancers (47%) in Scotland are diagnosed at a late stage (Stage IV), when the cancer has spread to other parts of the body.[4] AstraZeneca estimates that approximately 192 patients in Scotland with locally advanced or metastatic EGFRm NSCLC will be eligible for targeted therapy with osimertinib every year.

Dr Brian Clark, Consultant Clinical Oncologist at Beatson West of Scotland Cancer Centre, said: “Osimertinib is a third generation EGFR inhibitor that has demonstrated clear survival benefit in clinical trials when compared to the previous generation of these medicines. Getting access to this treatment is an important development for people living with advanced lung cancer in Scotland, as it provides them with a treatment option that has the potential to improve their outcomes and does not compromise quality of life.”

Results from the FLAURA Phase III trial showed a statistically significant and clinically meaningful improvement in median overall survival (OS) in patients treated with osimertinib, versus gefitinib or erlotinib, both of which were previous standard-of-care (SoC) treatments in this setting (38.6 versus 31.8 months; Hazard Ratio [HR] 0.799 [95% CI, 0.641-0.996], p=0.0462).2^,[5]

Osimertinib also showed a statistically significant and clinically meaningful 52% reduction in the risk of central nervous system (CNS) disease progression at 18 months, increasing the time patients with CNS metastases lived without CNS disease progression or death (HR 0.48 [95% CI, 0.26-0.86], p=0.014).2^,5 As patients with CNS lesions typically have poor outcomes, a reduction in CNS disease progression could potentially lead to an enhanced quality of life.[6]

Tom Keith-Roach, President, AstraZeneca UK, said: “This decision from the SMC is further welcome news aligned with the Scottish Government’s commitment to cancer as a national clinical priority. Providing access to cutting-edge treatments like osimertinib is an important part of getting back on track post-COVID.”

Arun Krishna, Head of Oncology, AstraZeneca UK, said: “With almost half of all lung cancers in Scotland diagnosed at a late stage, there is a clear unmet need for additional effective treatment options. Osimertinib can significantly increase survival of patients with EGFR mutation-positive NSCLC, with a comparable safety profile to first generation EGFR TKIs. It’s fantastic news that patients in Scotland now have access to this product of British science.”

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).5 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).5

[1] Scottish Medicines Consortium. Osimertinib 40mg and 80mg film-coated tablet (Tagrisso^®). SMC2382. Published 17 January 2022.

[2] Ramalingam S, et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med. 2020;382:41-50.

[3] Cancer in Scotland Summary. April 2019. NHS National Services Scotland. Available at: https://www.isdscotland.org/Health-Topics/Cancer/Publications/2019-04-30/Cancer_in_Scotland_summary_m.pdf. Last accessed: January 2022.

[4] Public Health Scotland. Cancer Incidence and Prevalence in Scotland (to December 2019). Published: 11 May 2021. Available at: https://publichealthscotland.scot/media/7753/2021-05-11-cancer-incidence-report.pdf. Last accessed: January 2022.

[5] Tagrisso (osimertinib). Summary of Product Characteristics. 6 May 2021. Available at: https://www.medicines.org.uk/emc/product/1985/smpc#gref. Last accessed: January 2022.

[6] Liu HM, Meng CL, Zhao LJ. Survival Outcomes of Local Compared With Systemic First Treatment of Non-Small Cell Lung Cancer Brain Metastases. Front Oncol. 2021;11:4598.