Imfinzi® (durvalumab) is the First Immunotherapy to Demonstrate Significant Overall Survival Benefits in Unresectable, Stage III Non-Small Cell Lung Cancer

Tuesday, September 25, 2018 Cancer News
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Phase III PACIFIC data presented at the IASLC 2018 World Conference on Lung Cancer in Toronto shows 32 per cent reduced risk of death

for patients treated with Imfinzi compared to standard of care

MISSISSAUGA, ON, Sept. 25, 2018 /CNW/ - Today, AstraZeneca presented full data from a planned interim analysis of

the Phase III PACIFIC trial at the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer in Toronto, Canada. The results showed statistically significant and clinically meaningful overall survival (OS) benefits for patients with unresectable Stage III non-small cell lung cancer (NSCLC) treated with Imfinzi (durvalumab), compared to placebo regardless of PD-L1 expression.

The Phase III PACIFIC trial results were simultaneously published in the New England Journal of Medicine, showing Imfinzi reduces risk of death by 32 per cent (hazard ratio [HR] 0.68, 99.73% confidence interval [CI]  0.47-0.997; p=0.0025). At follow up, median OS was not reached in the Imfinzi arm (NR; 95% CI, 34.7–NR). In the placebo arm, median OS was 28.7 months (95% CI, 22.9–NR).1

"The overall survival results from the Imfinzi PACIFIC trial represent a major breakthrough in treating patients with Stage III, unresectable non-small cell lung cancer," said Dr. Barbara Melosky, medical oncologist and Professor of Medicine, University of British Columbia. "Our goal in the Stage III lung cancer setting is to treat patients with the intent to cure them; today's data shows that we are getting closer to that goal by significantly extending life with treatment with Imfinzi following chemoradiation therapy."

The safety and tolerability profile of Imfinzi was consistent with that reported at the time of the progression-free survival (PFS) analysis. Among patients receiving Imfinzi, the most common adverse reactions (greater than or equal to 20% of patients) versus placebo were cough (35.2% vs. 25.2%), fatigue (24% vs. 20.5%), dyspnea (22.3% vs. 23.9%) and radiation pneumonitis (20.2% vs. 15.8%). Thirty per cent (30.5%) of patients experienced a grade 3 or 4 AE (adverse events) with Imfinzi vs 26.1 per cent with placebo, and 15.4 per cent of patients discontinued treatment due to AEs with Imfinzi compared to 9.8 per cent of patients on placebo.

Imfinzi is currently approved in Canada, the US, EU, Switzerland, India, Japan and Brazil based on the PACIFIC trial. Other global health authority reviews and submissions are ongoing.

About Lung Cancer and Stage III Advanced NSCLCLung 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, approximately 28,600 Canadians were diagnosed with lung cancer in 2017.2 This represented around 14 per cent of all new cancer cases in 2017.3

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.4 In Canada, on average, only 15.1 per cent of people diagnosed with NSCLC are likely to live five years after their diagnosis following chemoradiation therapy.5

While patients diagnosed with Stage III NSCLC 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 through metastasis.6

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

About the PACIFIC TrialThe PACIFIC trial is a Phase III, randomized, double-blinded, placebo-controlled, multi-centre trial of treatment with Imfinzi in 'all-comer' patients (i.e. regardless of PD-L1 status) with unresectable, Stage III (locally advanced) NSCLC who have not progressed following platinum-based chemoradiation therapy.

The trial is being conducted in 235 centres across 26 countries involving approximately 713 patients. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark PFS and OS, objective response rate (ORR) and duration of response.

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.

Reviewed under Health Canada's accelerated approval framework, Imfinzi received Notice of Compliance with Conditions (NOC/c) in May 2018 for the treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy.7 Approval was granted based on data from the Phase III PACIFIC trial demonstrating that Imfinzi extended PFS for patients by nearly one year (11.2 months) versus placebo.8 With this approval, Imfinzi became the first and only approved immuno-oncology therapy following chemoradiation therapy for patients in this setting.

Imfinzi has also been granted 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.9

Clinical studies of Imfinzi are ongoing, including the MYSTIC in NSCLC and CASPIAN in small-cell lung cancer. 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-OncologyImmuno-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.

References_____________________________1 Antonia, S., Villegas, A., Daniel, D., Vicente, D., Murakami, S., Hui, R., Kurata, T., (…), Özgüro?lu, M., Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. (2018) New England Journal of Medicine. Accessed September 25, 2018. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1809697?query=featured_home2 Canadian Cancer Statistics. 2017. Accessed August 16, 2018. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on3 Ibid4 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.68715 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.2009.26.25436 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). https://doi.org/10.1016/S1470-2045(14)71207-07 Ibid8 Ibid9 AstraZeneca Canada Inc., IMFINZI® (durvalumab), Product Monograph. May 2018.

SOURCE AstraZeneca



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