Imfinzi® (durvalumab) is the First Immunotherapy to Show Both Significant Survival Benefit and Improved, Durable Responses in Extensive-Stage Small Cell Lung Cancer
Data presented at the IASLC 2019 World Conference on Lung Cancer demonstrated the Phase III CASPIAN trial of Imfinzi improved survival with either a cisplatin or carboplatin chemotherapy backbone
MISSISSAUGA, ON, Sept. 12, 2019 /CNW/ - AstraZeneca presented detailed results from the Phase III CASPIAN trial, showing Imfinzi (durvalumab) significantly improved overall survival (OS) in patients with previously untreated extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options.
Imfinzi in combination with four cycles of standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically-significant and clinically-meaningful improvement in OS vs. SoC consisting of up to six cycles of chemotherapy and optional prophylactic cranial irradiation (PCI).
"Small cell lung cancer is a devastating diagnosis for anyone to receive, and the results of the CASPIAN trial offer much needed hope for patients who have had limited treatment options," said Dr. Quincy Chu, medical oncologist, University of Alberta, Cross Cancer Institute. "As an oncologist in daily contact with lung cancer patients, it's particularly encouraging to see the promising results of this research, and the progress being made to identify new treatment options in a disease area that has experienced such significant unmet need for over 30 years."
SCLC is the most aggressive type of lung cancer and recurs and progresses rapidly despite initial response to platinum-based chemotherapy.1 2
In the study, the risk of death was reduced by 27 per cent (equal to a hazard ratio of 0.73), with median OS of 13 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Results showed a prolonged OS benefit with an estimated 33.9 per cent of patients alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7 per cent of patients following SoC.
Across all efficacy endpoints, benefits were observed in patients treated with Imfinzi plus chemotherapy vs. SoC. Results showed a significantly higher progression-free survival (PFS) rate at 12 months (17.5% vs. 4.7%), a 10.3 per cent increase in confirmed objective response rate (ORR) (67.9% vs. 57.6%), and improved duration of response (DOR) at 12 months (22.7% vs. 6.3%).
The safety and tolerability of Imfinzi in combination with SoC etoposide and platinum-based chemotherapy was consistent with previous trials. Results showed that 61.5 per cent of patients experienced a Grade 3 or 4 adverse event with Imfinzi plus SoC (all causes) vs. 62.4 per cent with SoC, and patients discontinuing treatment due to AEs were similar between arms (9.4% vs. 9.4%).
The results were presented at the Presidential Symposium of the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain.
Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer after chemoradiotherapy in 49 countries, including Canada, the US, EU, Switzerland, India, Japan and Brazil based on the PACIFIC trial. Other global health authority reviews and submissions are ongoing.
CASPIAN is a randomized, open-label, multi-centre, global, Phase III trial of Imfinzi plus platinum-based chemotherapy options or the combination of Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone as a 1st-line treatment for patients with extensive-stage SCLC. The trial will continue to the final analysis of OS for the combination of Imfinzi, tremelimumab and chemotherapy.
About Lung Cancer and Extensive-Stage Small Cell Lung Cancer (SCLC)
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, approximately 28,600 Canadians were diagnosed with lung cancer in 2017.3 This represented around 14 per cent of all new cancer cases in 2017.4
While only representing 10 to 15 per cent of all lung cancers, SCLC is the most aggressive type of lung cancer.5 With treatment, extensive-stage SCLC has a median survival of 7 to 11 months.6
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.
In Canada, Imfinzi is approved for the treatment of patients with locally advanced, unresectable, Stage III non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.7
Imfinzi is also approved 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.8
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 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.
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.
1 Canadian Cancer Survivor Network. Lung Cancer Prognosis. Accessed September 6, 2019. Available at: http://survivornet.ca/cancer-type/lung-cancer/diagnosis-and-lung-cancer/prognosis-and-survival-statistics/
2 Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? Journal of Oncology Practice, volume 14, issue no. 6 (June 1, 2018) 369-370.
3 Canadian Cancer Statistics. 2017. Accessed September 6, 2019. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on
5 Canadian Cancer Survivor Network. Lung Cancer Prognosis. Accessed September 6, 2019. Available at: http://survivornet.ca/cancer-type/lung-cancer/diagnosis-and-lung-cancer/prognosis-and-survival-statistics/
6 Canadian Cancer Society. Survival Statistics for Small Cell lung Cancer. Accessed September 6, 2019. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/lung/prognosis-and-survival/small-cell-lung-cancer-survival-statistics/?region=on
7 AstraZeneca Canada Inc., IMFINZI® (durvalumab), Product Monograph. July 2019.
SOURCE AstraZeneca Canada Inc.