ASTRAZENECA RECEIVES TWO POSITIVE NICE RECOMMENDATIONS FOR LUNG CANCER PATIENTS ACROSS ENGLAND AND WALES
- Imfinzi (durvalumab) in combination with etoposide plus either carboplatin or cisplatin has been recommended by the National Institute for Health and Care Excellence (NICE) for adults with untreated extensive-stage small cell lung cancer (ES-SCLC).[1]
- NICE's decision was informed by positive results from the CASPIAN Phase III trial, which showed that adding durvalumab to standard chemotherapy provides a clinically significant and sustained overall survival (OS) benefit at three years.[2]
- Tagrisso (osimertinib) has been recommended by NICE as an adjuvant treatment option 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.[3]
- NICE’s decision was informed by positive results from the ADAURA Phase III trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) EGFRm NSCLC after complete tumour resection with curative intent.[4]
- The UK has one of the worst five-year survival rates for lung cancer in Europe and 70% of lung cancers are diagnosed at an advanced stage (stages III-IV), which is associated with significantly poorer outcomes.[5],[6]
London, UK, Wednesday 22 January 2025 – AstraZeneca announced that this week it has received two positive recommendations from the National Institute for Health and Care Excellence (NICE) for the treatment of lung cancer patients across England and Wales.1,3
Tagrisso (osimertinib) received a positive recommendation from NICE for NHS use as an adjuvant treatment option 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.3 Following a three-year period within the Cancer Drugs Fund (CDF), this recommendation means that osimertinib has successfully exited the CDF, enabling full baseline commissioning within NHS England for this patient population.[7]
Imfinzi (durvalumab) was recommended by NICE for NHS use in combination with etoposide plus either carboplatin or cisplatin for adults with untreated extensive-stage small cell lung cancer (ES-SCLC).1
Durvalumab in lung cancer
Lung cancer is the most common cause of cancer death in the UK, accounting for 21% of all cancer deaths.[8],[9] Nearly 50,000 people, more than 130 each day, are diagnosed with lung cancer each year in the UK.8 SCLC is a highly aggressive and fast-growing form of lung cancer that typically recurs and progresses rapidly.[10],[11] ES-SCLC occurs when the cancer has spread to the second lung or other parts of the body.[12]
Dr Meenali Chitnis, Consultant Thoracic Medical Oncologist, Oxford University, said: “Extensive-stage small cell lung cancer (ES-SCLC) is a devastating diagnosis with a poor prognosis – with fewer than 5% of patients surviving beyond two years. Positive data from the CASPIAN Phase III trial marks an important breakthrough, providing clinicians with an effective treatment option of durvalumab with etoposide plus carboplatin or cisplatin.”
The positive determination from NICE was based on results from the pivotal CASPIAN Phase III trial.[13],[14] Results of a two-year follow-up analysis, published in 2020, showed that first-line treatment with durvalumab plus platinum chemotherapy met the primary endpoint of the trial and demonstrated significant and clinically meaningful improvements in overall survival (OS) in patients with ES-SCLC versus chemotherapy alone (based on a hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047).13 The safety findings from the trial were consistent with the known safety profiles of durvalumab and chemotherapy.13
Updated results from the CASPIAN Phase III trial presented at the European Society of Medical Oncology (ESMO) Congress 2021, showed that durvalumab plus platinum chemotherapy reduced the risk of death by 29% compared with chemotherapy alone (HR of 0.71; 95% CI 0.60-0.86; nominal p=0.0003) at three years.2,14 The updated median OS was 12.9 months versus 10.5 for chemotherapy.2,14
Tom Keith-Roach, President, AstraZeneca UK, said: “This is fantastic news for lung cancer patients. We are proud that these decisions by NICE mean we've had 28 positive recommendations by NICE and the SMC since 2021 across multiple cancer types and stages. This represents another step towards our bold ambition to one day eliminate cancer as a cause of death.”
Osimertinib in lung cancer
NSCLC is the most common lung cancer, accounting for around 80-85% of cases.[15] Around 12% of patients with NSCLC have tumours with EGFR mutations.[16] Patients with early-stage NSCLC often undergo surgery with curative intent as standard of care – however, disease recurrence following surgery remains high, and has been reported to occur in 30-50% of patients.[17]
The positive recommendation from NICE for osimertinib was based on results from the ADAURA Phase III trial.4 In which, 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<0.001).4 Survival without disease recurrence at two years was 90% (95% CI 84-93) for osimertinib and 44% (95% CI 37-51) for placebo.4 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.4 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.4
Lung cancer causes more deaths in the UK than any other cancer and more than bladder, pancreatic, and kidney cancers combined.9,[18] The UK has some of the worst lung cancer diagnosis and survival rates in the developed world.5 The economic burden is significant, with lung cancer costing the UK economy £698.9M each year.[19]
[1] National Institute for Health and Care Excellence. Final Draft Guidance. Durvalumab with etoposide and either
carboplatin or cisplatin for untreated extensive-stage small-cell lung cancer. Available at: https://www.nice.org.uk/guidance/gid-ta11515/documents/674. Last accessed: January 2025.
[2] Paz-Ares, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN. ESMO Open, Volume 7, Issue 2, 2022. Available at:
https://www.esmoopen.com/action/showPdf?pii=S2059-7029%2822%2900029-1 Last accessed: January 2025.
[3] National Institute for Health and Care Excellence. Final Draft Guidance. Osimertinib for adjuvant treatment of EGFR
mutation-positive non-small-cell lung cancer after complete tumour resection (review of TA761). Issue date: 21 January 2025.
[4] 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.
[5] Arnold, M, et al. Progress in cancer survival, mortality, and incidence in seven high-income countries 1995–2014 (ICBP SURVMARK-2): a population-based study. The Lancet Oncology. 2019;20(11):1493-1505.
[6] NHS Digital. Cancer Registration Statistics, England 2020. Available at: https://digital.nhs.uk/data-and-information/publications/statistical/cancer-registration-statistics/england-2020/cancer-incidence-by-stage. Last accessed: January 2025.
[7] National Institute for Health and Care Excellence. Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection. Available at: https://www.nice.org.uk/guidance/ta761. Last accessed: January 2025.
[8] Cancer Research UK, Lung cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer. Last accessed: January 2025.
[9] Cancer Research UK. Lung cancer mortality statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer/mortality. Last accessed: January 2025.
[10] National Cancer Institute. NCI Dictionary - Small Cell Lung Cancer. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. Last accessed: January 2025.
[11] Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? Journal of Oncology Practice. 2018;14(6): 369-370.
[12] Kalemkerian GP, et al. Staging and imaging of small cell lung cancer. Cancer Imaging. 2012 Jan 12;11(1):253-8.
[13] Goldman J W. et al. Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study. Lung Cancer. 2020;149:46-52.
[14] National Institute for Health and Care Excellence. Single Technology Appraisal. Durvalumab with etoposide and platinum-based chemotherapy for untreated extensive-stage small-cell lung cancer [ID6404]. Committee Papers. Available at: https://www.nice.org.uk/guidance/gid-ta11515/documents/committee-papers. Last accessed: January 2025.
[15] NHS England. Thousands more lung cancer patients to get innovative blood test as part of NHS pilot. Available at: https://www.england.nhs.uk/2024/03/thousands-more-lung-cancer-patients-to-get-innovative-blood-test-as-part-of-nhs-pilot/. Last accessed: January 2025.
[16] Midha A, Dearden S, McCormack R. EGFR mutation incidence in non-small cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity (mutMapII). Am J Cancer Res. 2015;5;2892-2911.
[17] Uramoto H, et al. Recurrence after surgery in patients with NSCLC. Translational Lung Cancer Research. 2013;12;5:2218-6751.
[18] Cancer Research UK. Cancer mortality for common cancers. Available at: Cancer mortality for common cancers | Cancer Research UK. Last accessed: January 2025.
[19] Frontier Economics. The societal and economic costs of preventable cancers in the UK. Available at: The social and economic costs of preventable cancers in the UK. Last accessed: January 2025.
