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17-May-2022

IMFINZI (durvalumab) ACCEPTED FOR ROUTINE USE WITHIN NHS ENGLAND FOR ADULTS WITH STAGE III UNRESECTABLE NON-SMALL CELL LUNG CANCER

IMFINZI (durvalumab) ACCEPTED FOR ROUTINE USE WITHIN NHS ENGLAND FOR ADULTS WITH STAGE III UNRESECTABLE NON-SMALL CELL LUNG CANCER

  • Imfinzi (durvalumab) is recommended by the National Institute for Health and Care Excellence (NICE) for routine use for eligible patients in England with stage III unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells following concurrent platinum-based chemoradiation therapy (cCRT).1
  • Updated long-term results from the PACIFIC Phase III trial showed an estimated five-year overall survival rate of 42.9% for durvalumab vs 33.4% for placebo, establishing a new benchmark in this setting.2
  • More than 34,000 people in England are diagnosed with NSCLC every year.3

London, UK, 13 May 2022 – AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) has recommended Imfinzi (durvalumab) for routine use within NHS England as monotherapy for the treatment of locally advanced stage III unresectable (unable to surgically remove) non-small-cell lung cancer (NSCLC) in adults whose tumours express a protein called PD-L1 on at least 1% of tumour cells, and whose disease has not progressed following concurrent platinum-based chemoradiation therapy (cCRT).4

In May 2019, durvalumab was made available as a treatment option for these patients via the Cancer Drugs Fund (CDF) – a scheme that provides patients with faster access to new cancer treatments.5 Today, after reviewing additional efficacy and safety data for durvalumab in these patients, NICE has recommended routine access to this treatment.1

Dr Patricia Fisher, Consultant Clinical Oncologist at Sheffield Teaching Hospitals NHS Foundation Trust, said: “Sadly not all people with stage III unresectable non-small cell lung cancer are treated with the intention to cure and those that are, many will progress to develop advanced incurable disease. Since durvalumab was made available within the CDF, we have seen a significant shift to more patients being treated with concurrent chemoradiation therapy because they then have the option to follow this with immunotherapy, giving them the chance of improved outcomes. Today’s positive recommendation by NICE should increase clinician confidence in using a combination of therapies in this setting.”

Lung cancer remains the most common cause of cancer death in the UK, accounting for over one in five (21%) of all cancer deaths.6 More than 34,000 people in England are diagnosed with NSCLC every year,3 and roughly 20% of these are diagnosed at stage III.7 Stage III NSCLC can be treated with curative intent, whereas if the patient progresses to stage IV disease (also known as metastatic), treatment goals are limited to prolonging life and providing best supportive care.8,9,10,11

Tom Keith-Roach, President, AstraZeneca UK, said: “I’m delighted that this group of stage III NSCLC patients will have routine access to this immunotherapy for the first time. This is a great example of how collaboration with NICE and NHS England through the Cancer Drugs Fund has enabled early and now continuing access to durvalumab for stage III NSCLC patients in the UK.”

Arun Krishna, Head of Oncology, AstraZeneca UK, said: “We are delighted by NICE’s decision to make durvalumab available for routine use within England. Our priority now is to make strides in the curative intent setting by working with clinicians to routinely embed durvalumab into the treatment pathway to deliver better survival outcomes for lung cancer patients."

Results from the updated post-hoc analyses in the PACIFIC Phase III trial showed an estimated five-year overall survival (OS) rate of 42.9% for patients treated with durvalumab after cCRT versus 33.4% for those on placebo.2 Median OS was 47.5 months for durvalumab versus 29.1 for placebo.2 Following a maximum treatment course of one year, an estimated 33.1% of patients treated with durvalumab had not progressed five years after enrolment versus 19% for placebo.2 These long-term results build on the primary progression-free survival (PFS) and OS analyses published in The New England Journal of Medicine in 2017 and 2018, which demonstrated a sustained, significant benefit with durvalumab for these primary endpoints.12,13

Across the PACIFIC Phase III trial, the most common adverse reactions included: neutropenia (48.7% all grades; 29.1% grade 3-4), anaemia (38.5% all grades; 9.1% grade 3-4), thrombocytopenia (21.1% all grades; 6.8% grade 3-4), leukopenia (20.0% all grades; 7.9% grade 3-4), decreased appetite (18.1% all grades; 0.8% grade 3-4), cough/productive cough (14.7% all grades; 0.8% grade 3-4), nausea (33.6% all grades; 0.4% grade 3-4), constipation (16.6% all grades; 0.8% grade 3-4), vomiting (14.7% all grades; 0 grade 3-4), alopecia (31.3% all grades; 1.1% grade 3-4) and fatigue (32.1% all grades; 3.4% grade 3-4).4 Common adverse reactions included: upper respiratory tract infections (9.1% all grades; 0.4% grade 3-4), hypothyroidism (9.4% all grades; 0 grade 3-4), hyperthyroidism (9.8% all grades; 0 grade 3-4); abdominal pain (8.7% all grades; 0.4% grade 3-4), aspartate aminotransferase increased or alanine aminotransferase increased (8.7% all grades; 1.9% grade 3-4), and rash (9.4% all grades; 0 grade 3-4).4

                                                                                                                          – ENDS –

CONTACTS

UK Media Enquiries

Emma White, AstraZeneca: 07385 516437 / emma.white1@astrazeneca.com

Jack Faulkner, Edelman: 07813 407324 / jack.faulkner@edelman.com 

NOTES TO EDITORS

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Any side effects should be reported. See www.mhra.gov.uk/yellowcard for how to report side effects.

About durvalumab

Durvalumab is a human monoclonal antibody that targets the programmed death ligand-1 (PD-L1), an important part of the mechanism that cancer cells use to hide from the body’s immune system. PD-L1 is expressed on T-cells and tumour cells. By selectively blocking PD-L1, durvalumab can enable the immune system to recognise and attack the cancer cell.14,15

The summary of product characteristics for durvalumab is available at: https://www.medicines.org.uk/emc/product/9495/smpc 

About PACIFIC

The PACIFIC trial is a global Phase III, randomised, double-blind, placebo-controlled, multi-centre study of durvalumab as a sequential therapy in 713 enrolled patients with locally advanced (stage III), unresectable NSCLC whose disease has not progressed following platinum-based, concurrent chemoradiation therapy.16 The primary objective of the PACIFIC trial is to assess the effects of durvalumab vs. placebo for both progression-free survival and overall survival.16

About lung cancer

Lung cancer is the most common cause of cancer death in the UK, accounting for one in five (21%) of all cancer deaths.6 NSCLC is the most common type – more than 34,000 people in England are diagnosed with NSCLC every year,3 and roughly 20% of these are diagnosed at stage III.6 Approximately 25-30% of patients with NSCLC present with resectable disease at diagnosis.17,18,19

The UK has one of the worst five-year survival rates for lung cancer in Europe.20

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

AstraZeneca is based in five different locations across the UK, with its global headquarters in Cambridge. In the UK, around 8,300 employees work in research and development, manufacturing, supply, sales and marketing. We supply 40 different medicines to the NHS.

For more information, please visit www.astrazeneca.co.uk and follow us on Twitter @AstraZenecaUK.

References

  1. National Institute for Health and Care Excellence. Final Appraisal Document. Durvalumab for maintenance treatment of unresectable non-small-cell lung cancer after platinum-based chemoradiation. Issue date: May 2022.
  2. Spigel DR, Faivre-Finn C, Gray JE, et al. Five-year Survival Outcomes From the PACIFIC trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. Journal of Clinical Oncology. 2021;39:15;8511.
  3. Royal College of Physicians. National Lung Cancer Audit 2017 information sheet. Published January 2018. Available at: https://www.rcplondon.ac.uk/file/8703/download?token=2UCmNec9. Last accessed: May 2022.
  4. Imfinzi 50 mg/mL concentrate for solution for infusion. 9 December 2021. https://www.medicines.org.uk/emc/product/9495/smpc
  5. National Institute for Health and Care Excellence. Final Appraisal Document. Durvalumab for treating locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation. Issue date: March 2019.
  6. Cancer Research UK. Cancer mortality for common cancers. Twenty most common causes of cancer death. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/mortality/common-cancers-compared#heading-Zero. Last accessed: May 2022.
  7. Evison M. The current treatment landscape in the UK for stage III NSCLC. British Journal of Cancer. 2020;123:3-9.
  8. Roy Castle Lung Cancer Foundation. Staging. Available at https://www.roycastle.org/how-we-help/lung-cancer-information/understand-the-disease/staging. Last accessed: May 2022.
  9. Zarogoulidis K, Zarogoulidis P, Darwiche K, et al. Treatment of non-small cell lung cancer (NSCLC). J Thorac Dis. 2013; 5 Suppl 4:S389-S396.
  10. Cancer Research UK. Lung cancer: stage 3. Available at: https://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/stage-3. Last accessed: May 2022.
  11. Postmus PE, Kerr KM, Oudkerk M, et al. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2017;28(Supplement 4):iv1-iv21.
  12. Anthonia SJ et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377:1919-1929.
  13. Antonia SJ, et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018;379:2342-2350.
  14. Stewart R, Morrow M, Hammond SA, et al. Identification and characterization of MEDI4736, an antagonistic anti–PD-L1 monoclonal antibody. Cancer Immunol Res. 2015;3:1052-1062.
  15. Patel S, Kurzrock R. PD-L1 expression as a predictive biomarker in cancer immunotherapy. Mol Cancer Ther. 2015;14:847-856.
  16. Clinicaltrials.gov. A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC). Available at: https://clinicaltrials.gov/ct2/show/NCT02125461. Last accessed: May 2022.
  17. Cagle PT, Allen TC, Olsen RJ. Lung cancer biomarkers: present status and future developments. Arch Pathol Lab Med. 2013;137:1191–1198.
  18. Datta D, Lahiri B. Preoperative evaluation of patients undergoing lung resection surgery. Chest. 2003;123:2096–2103.
  19. Le Chevalier T. Adjuvant chemotherapy for resectable non-small-cell lung cancer: where is it going? Ann Oncol. 2010;21:196–198.
  20. Allemani C, et al. Global surveillance of trends in cancer survival: analysis of individual records for 37,513,025 patients diagnosed with one of 18 cancers during 2000–2014 from 322 population-based registries in 71 countries (CONCORD-3). Lancet. 2018 March 17; 391(10125): 1023–1075. doi:10.1016/S0140-6736(17)33326-3.

Editor Details

Last Updated: 19-May-2022