ASTRAZENECA SECURES LICENSE EXTENSION AND EARLY NHS ENGLAND ACCESS TO TAGRISSOTM (osimertinib) FOR PATIENTS WITH COMPLETELY RESECTED EARLY-STAGE EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER

ASTRAZENECA SECURES LICENSE EXTENSION AND EARLY NHS ENGLAND ACCESS TO TAGRISSO^TM      (osimertinib) FOR PATIENTS WITH COMPLETELY RESECTED EARLY-STAGE EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER

• This is the first authorisation to be issued by the MHRA under Project Orbis.¹
• AstraZeneca, NHS England and NICE have reached an agreement to enable early access to osimertinib for patients with this type of cancer, while NICE undertakes its appraisal.
• Patients with early-stage lung cancer are treated with the intention of cure; however, many relapse because treatment is limited to surgery and adjuvant chemotherapy.²
• Unprecedented clinical trial data show that osimertinib, the first approved targeted oral therapy in this setting, can reduce the risk of disease recurrence or death by 80% in patients with early-stage (IB-IIIA) EGFR mutation-positive NSCLC versus placebo.³

Luton, UK, 7^th May 2021 – AstraZeneca today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a license extension for Tagrisso (osimertinib) in Great Britain, for use 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.⁴ This is the first authorisation to be issued by the MHRA under Project Orbis, a collaborative, global programme designed to deliver faster patient access to innovative cancer treatments.¹

An agreement with NHS England and the National Institute for Health and Care Excellence (NICE) will enable early access to osimertinib for all patients in England with this specific type of lung cancer. Access is given ahead of official NICE guidance to ensure patients have the chance to benefit from this new treatment option as soon as possible. NICE guidance is not expected to be published until September 2021 at the earliest.⁵

Dr Carles Escriu, Consultant in Thoracic Medical Oncology at The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool, said: “Today’s news is potentially practice-changing because, for the first time, we have access to a targeted treatment for early-stage lung cancer. Osimertinib is a well-tolerated, once-daily tablet treatment and data show that, when taken after surgery, it can reduce the risk of disease recurrence or death by 80% after two years of treatment in patients with Stage IB-IIIA non-small cell lung cancer who have an EGFR mutation. Early-stage lung cancer patients can now be tested for EGFR mutations to give them the chance of delaying the return of cancer after surgery.”

Arun Krishna, Head of Oncology, AstraZeneca UK, said: “Patients diagnosed in the earlier stages of EGFR mutation-positive non-small cell lung cancer have the best chance of living disease-free, but many see their cancer return. Osimertinib, which was discovered by AstraZeneca scientists in the UK, could significantly improve patient outcomes in a disease setting that has had no new treatment options in over a decade. With this in mind, we have worked with urgency to secure the MHRA license and access in England to bring this treatment option to patients as quickly as possible. We will continue to work with authorities in the other nations of the UK to secure patient access at the earliest opportunity.”

The standard of care for patients with early-stage lung cancer 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

In the ADAURA Phase III trial, adjuvant treatment (after surgery) with osimertinib in patients with stage II-IIIA EGFR mutation-positive 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 When looking at the broader group of patients (stage IB-IIIA) – a secondary endpoint – treatment with osimertinib reduced the relative risk of disease recurrence or death by 80% compared to placebo, after 24 months of treatment (HR = 0.20; 99.12% CI: 0.14, 0.30; P<0.001).³

Data from ADAURA also show that, at two years in patients with stage IB-IIIA disease, 89% of patients treated with osimertinib after surgery remained alive and disease-free versus 52% on placebo.³

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).⁴ 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).⁴