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.
Tagrisso (osimertinib) received a positive recommendation from NICE for NHS use as an adjuvant treatment option after complete tumor resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. 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.
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).
Durvalumab in lung cancer
Lung cancer is the most common cause of cancer death in the UK, accounting for 21% of all cancer deaths. Nearly 50,000 people, more than 130 each day, are diagnosed with lung cancer each year in the UK. SCLC is a highly aggressive and fast-growing form of lung cancer that typically recurs and progresses rapidly. ES-SCLC occurs when the cancer has spread to the second lung or other parts of the body.
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. 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). The safety findings from the trial were consistent with the known safety profiles of durvalumab and chemotherapy.
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. The updated median OS was 12.9 months versus 10.5 for chemotherapy.
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.”
Tom Keith-Roach, President, AstraZeneca UK
Osimertinib in lung cancer
NSCLC is the most common lung cancer, accounting for around 80-85% of cases. Around 12% of patients with NSCLC have tumors with EGFR mutations. 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.
The positive recommendation from NICE for osimertinib was based on results from the ADAURA Phase III trial. 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). Survival without disease recurrence at two years was 90% (95% CI 84-93) for osimertinib and 44% (95% CI 37-51) for placebo. 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.
Lung cancer causes more deaths in the UK than any other cancer and more than bladder, pancreatic, and kidney cancers combined. The UK has some of the worst lung cancer diagnosis and survival rates in the developed world. The economic burden is significant, with lung cancer costing the UK economy £698.9M each year.
Protein CD74 could predict immunotherapy response in bowel cancer