First and Only Immuno-Oncology Treatment, Imfinzi® (durvalumab), for Stage III, Unresectable Non-Small Cell Lung Cancer Now Approved in Canada

Patients receiving Imfinzi in the PACIFIC clinical trial lived for nearly one year without their disease progressing versus placebo

MISSISSAUGA, ON, May 9, 2018 – AstraZeneca Canada today announced that Health Canada has approved Imfinzi® (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).i With this approval, Imfinzi becomes the first and only approved immuno-oncology therapy following CRT for patients in this setting. Reviewed under Health Canada’s accelerated approval framework, Imfinzi has been granted Notice of Compliance with Conditions (NOC/c) based on data from the phase III PACIFIC trial demonstrating that Imfinzi extended progression-free survival for patients by nearly one year (11.2 months) versus placebo.ii

Patients who are diagnosed in the stage III setting before their lung cancer has spread to other parts of their body are treated with the intent to cure the cancer with a combination of surgery, radiation therapy and/or chemotherapy. Despite this, the majority will eventually have their cancer spread. Over the past twenty years, research into improving outcomes for these patients has resulted in no significant benefit.iii Imfinzi is the first therapy to be able to delay the progression of lung cancer in these patients.

The approval of Imfinzi is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial in which Imfinzi demonstrated an improvement in median PFS of nearly one year (11.2 months) compared to placebo, representing a 48 per cent reduction in relative risk of progression or death vs. placebo in all patients, regardless of programmed death-ligand 1 (PD-L1) status.iv The PACIFIC trial is ongoing to evaluate overall survival (OS) in unresectable Stage III NSCLC. Detailed interim results of the PACIFIC trial were published online in the New England Journal of Medicine (NEJM).

Overall, the incidence and severity of adverse events were comparable for patients receiving Imfinzi compared to the patients receiving placebo. In patients receiving Imfinzi, the most common adverse reactions (greater than or equal to 20% of patients) were cough (40%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), and rash (22%).v Discontinuation after concurrent CRT due to adverse reactions, regardless of causality, occurred in 8 per cent of patients receiving Imfinzi vs. 6 per cent of patients receiving placebo.vi

Quotes

“Health Canada’s approval of Imfinzi heralds a new era in the treatment of stage III, unresectable lung cancer. Despite its often deadly prognosis, we attempt to treat these patients with the intent to cure their disease. We have been long awaiting a new therapeutic option that can offer some hope post-chemoradiation therapy. With Imfinzi, we now have a proven, approved treatment that may significantly improve outcomes for patients within this disease setting.”

- Dr. Rosalyn Juergens, Medical Oncologist, Juravinski Cancer Centre

“This approval marks a significant milestone for a great proportion of lung cancer patients who now have an effective treatment option following curative-intent chemoradiation. The progression-free survival rates seen with Imfinzi are unprecedented in their impact in this disease setting where there have been no other beneficial treatments to offer patients in the last two decades.”

- Dr. Rob El-Maraghi, Medical Oncologist at the Simcoe Muskoka Regional Cancer Centre

“Over the last three years, immunotherapy has been a major development in the treatment of metastatic lung cancer, but the arrival of Imfinzi is a revolution in the treatment of stage III, unresectable non-small cell lung cancer. Imfinzi delays recurrences of lung cancer by a median of nearly an additional year. It’s the first immunotherapy that stimulates our immune system to address the residual microscopic disease left undetectable after chemotherapy and radiation. This give more hope to patients than watching and waiting for recurrence in the majority of cases.”

- Dr. Marie Florescu Clinical Investigator and Assistant Clinical Professor, Department of Medicine, Université de Montréal

“Health Canada’s approval of Imfinzi is welcome news for patients living with stage III, unresectable non-small cell lung cancer and gives them a better chance at survival. Health Canada approval is a first step. We call on all stakeholders to work together so that it is publicly funded for all that need it.”

- Shem Singh, Executive Director, Lung Cancer Canada

About Lung Cancer and Stage III Advanced NSCLC

Lung cancer is the leading cause of cancer death in both men and women in Canada and is the most commonly diagnosed cancer. According to the Canadian Cancer Society (CCS), approximately 28,600 Canadians will be diagnosed with lung cancer in 2017. This represents around 14 per cent of all new cancer cases in 2017.vii

Stage III, non-small cell lung cancer (NSCLC) represents approximately 35 per cent of all new NSCLC diagnoses, and approximately 80 per cent of these patients are unsuitable for surgery.viii In Canada, on average, only 15.1 per cent of people diagnosed with NSCLC are likely to live five years after their diagnosis following CRT.ix

Stage III NSCLC is divided into three stages (IIIA, IIIB and IIIC), which are defined by the size and location of the tumour, by how much the cancer has spread locally and the possibility of surgery.x While patients diagnosed in this setting are treated with the intent to cure the cancer, the majority of patients who benefit from chemoradiation therapy, up to 70 per cent, experience progression to metastatic disease.xi

For more information about lung cancer visit www.LVNG.ca.

About Imfinzi (durvalumab)

Imfinzi is a fully human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi has already been granted Notice of Compliance with Conditions (NOC/c) in Canada for the treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.xii

Clinical studies of Imfinzi are ongoing, including the MYSTIC, NEPTUNE and PEARL Phase III trials in which Imfinzi is being studied for 1st-line treatment as monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody and potential new medicine, for the treatment of metastatic NSCLC. The POSEIDON trial is investigating Imfinzi with and without tremelimumab in combination with chemotherapy in a similar patient population.

About AstraZeneca’s Approach to Immuno-Oncology

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the majority of patients.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company’s website at www.astrazeneca.ca.

CONTACT:

Michelle Marchione

Senior Manager, Corporate Communications, AstraZeneca Canada

Tel: 1-800-565-5877 x 45749

Email: michelle.marchione@astrazeneca.ca

References

i AstraZeneca Canada Inc., IMFINZI® (durvalumab), Product Monograph. April 2018.

ii Ibid

iii Denton, Eve, and Matthew Conron. “Improving Outcomes in Lung Cancer: The Value of the Multidisciplinary Health Care Team.” Journal of Multidisciplinary Healthcare 9 (2016): 137–144. PMC. 13 Apr. 2018. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4820200/

iv AstraZeneca Canada Inc., IMFINZI® (durvalumab), Product Monograph. April 2018.

v Ibid

vi Ibid

vii Canadian Cancer Statistics. 2017. Accessed April 9, 2018. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on

viii Zhao, Q., Wang, Z., Huang, W., Wang, Q., Yu, S., Zhou, T., … Li, B. (2016). Phase III study of cisplatin with pemtrexed or vinorelbine plus concurrent late course accelerated hyperfractionated radiotherapy in patients with unresectable stage III non-small cell lung cancer. Oncotarget, 7(7), 8422–8431. http://doi.org/10.18632/oncotarget.6871

ix Auperin, A., Le Pechoux, C., Rolland, E., Curran, W., Furuse, K., Fournel, P. (2010) Meta-Analysis of Concomitant Versus Sequential Radiochemotherapy in Locally Advanced Non–Small-Cell Lung Cancer. Journal of Clinical Oncology 28, no. 13 (May 2010). http://ascopubs.org/doi/full/10.1200/JCO.2009.26.2543

x The National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Non-Small Cell Lung Cancer. Version 122018. Available at https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf Accessed January 2018.

xi Bradley J.D., Paulus R., Komaki R., Masters G., Blumenschein G., Schild S., Bogart J., (...), Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): A randomised, two-by-two factorial phase 3 study. (2015) The Lancet Oncology, 16 (2). http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)71207-0/fulltext/p>

xii AstraZeneca Canada Inc., IMFINZI® (durvalumab), Product Monograph. April 2018.

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  • 2018
  • May