IMFINZI® (Durvalumab) is the Only Immunotherapy to Demonstrate Overall Survival at Three Years in Unresectable, Stage III Non-Small Cell Lung Cancer
- Category: Antibodies
- Published on Sunday, 02 June 2019 17:26
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Data presented at ASCO 2019 showed 57% of patients alive at three years vs. 43.5% on placebo
WILMINGTON, DE, USA I June 02, 2019 I AstraZeneca has presented three-year overall survival (OS) results from the Phase III PACIFIC trial of IMFINZI® (durvalumab) in unresectable, Stage III non-small cell lung cancer (NSCLC) during the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The latest results from this post-hoc analysis show longer-term OS evidence in patients with unresectable, Stage III NSCLC who had not progressed following concurrent chemoradiation therapy (CRT), a previous standard-of-care (SoC) treatment. The OS rate was 57% at three years for patients receiving IMFINZI vs. 43.5% for placebo following concurrent CRT. Median OS was not yet reached with the IMFINZI arm versus 29.1 months for placebo.
Dave Fredrickson, Executive Vice President, Oncology Business said: “These findings for IMFINZI are another example of our focus on bringing long-term survival benefits to patients who still have a chance of being cured. These three-year survival results further establish the PACIFIC regimen as the standard of care for these patients, and we are optimistic that this survival trend will continue as we move towards the five-year landmark in this curative-intent setting.”
Results build on the primary two-year OS analysis that was published in The New England Journal of Medicine in September 2018 and demonstrated a significant OS benefit for treatment with IMFINZI vs. placebo after CRT, regardless of PD-L1 expression. The primary analysis showed IMFINZI reduced the risk of death by 32% (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025).
With the additional year of follow up, the latest results for IMFINZI showed consistent efficacy, maintaining a 31% reduction in the risk of death vs. placebo after CRT (HR 0.69, [95% CI 0.55-0.86]).
Jhanelle Gray, MD, Director of Clinical Research in the Thoracic Oncology Department at Moffitt Cancer Center in Tampa, Florida, and an investigator in the PACIFIC trial, said: “In the past, patients with unresectable, Stage III non-small cell lung cancer faced five-year survival rates of only 15 to 30%. It is remarkable to see more than half of the patients treated with the PACIFIC regimen alive after three years, an important milestone in this curative-intent setting.”
IMFINZI can cause serious, potentially fatal adverse events (AEs). In the previous two-year OS analysis, the most common adverse reactions (greater than or equal to 20% of patients) for patients receiving IMFINZI versus placebo were cough (35.2% vs. 25.2%), fatigue (24.0% vs. 20.5%), dyspnea (22.3% vs. 23.9%) and radiation pneumonitis (20.2% vs. 15.8%). 30.5% of patients experienced a grade 3 or 4 AE with IMFINZI vs. 26.1% with placebo, and 15.4% of patients discontinued treatment due to AEs with IMFINZI vs. 9.8% of patients on placebo.
Building on PACIFIC
AstraZeneca has several ongoing trials focused on testing IMFINZI® (durvalumab) in earlier stages of NSCLC (Stage I-III) and in potentially-curative settings. The Phase III PACIFIC-2 trial design, presented today at the ASCO Annual Meeting, is evaluating IMFINZI given concurrently with CRT in patients with unresectable, Stage III NSCLC.
IMFINZI is approved for the treatment of unresectable, Stage III non-small cell lung cancer in more than 45 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial. Since the first approval in the US in February 2018, more than 20,000 patients in this setting have been treated with IMFINZI.
IMFINZI is indicated for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
Please see complete Prescribing Information, including Medication Guide.
NOTES TO EDITORS
The PACIFIC trial is a Phase III, randomized, double-blinded, placebo-controlled, multi-center trial of IMFINZI® (durvalumab) as treatment in ”all-comer” patients (i.e., regardless of PD-L1 status) with unresectable Stage III NSCLC whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT).
The trial is being conducted in 235 centers across 26 countries involving 713 patients. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), and secondary endpoints include landmark PFS and OS, overall response rate (ORR) and duration of response (DoR).
About Stage III NSCLC
Stage III (locally advanced) non-small cell lung cancer (NSCLC) is commonly divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. Stage III disease is different from Stage IV disease, when the cancer has spread (metastasized) to distant organs, as Stage III is currently treated with curative intent.
Approximately one in four patients with NSCLC in the United States present with Stage III disease, which is estimated to affect over 43,000 patients. The majority of Stage III NSCLC patients are diagnosed with unresectable tumors. Until recently, the standard of care beyond CRT was active surveillance to monitor for progression as there had been no FDA approved treatments following CRT.
About IMFINZI® (durvalumab)
IMFINZI® (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
IMFINZI is approved for unresectable, Stage III NSCLC in more than 45 countries including the US, EU, and Japan based on the Phase III PACIFIC trial.
As part of a broad development program, IMFINZI is also being tested as a monotherapy and in combination with tremelimumab, an investigational anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small cell lung cancer (SCLC), bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumors.
About AstraZeneca Support Programs
AstraZeneca strives to ensure that appropriate patients and their oncologists have access to IMFINZI and relevant support resources. These include educational resources, an Oncology Nurse Educator program and affordability and reimbursement programs, such as Access 360™.
Additionally, AstraZeneca has launched Lighthouse, a program that provides support to patients during any immune-mediated adverse events they may encounter during treatment, through medically trained Lighthouse Advocates. The program aims to make patients’ treatment experience as comfortable as possible. Find out more about Lighthouse at LighthouseProgram.com or call 1-855-LHOUSE1 (1-855-546-8731).
About AstraZeneca in Lung Cancer
AstraZeneca has a comprehensive portfolio of approved and investigational medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease and lines of therapy. We aim to address the unmet needs of patients with EGFR-mutated tumors as a genetic driver of disease, which occur in approximately 7-23% of patients in Western populations, and 30-40% of Asian patients, with our approved medicine TAGRISSO® and ongoing Phase III trials FLAURA, ADAURA and LAURA, as well as the Phase II exploratory combination trials SAVANNAH and ORCHARD.
Our extensive late-stage Immuno-Oncology program focuses on 75-80% of patients with lung cancer without a known genetic mutation. IMFINZI, an anti-PD-L1 antibody, is in development as monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5 and PEARL) and in combination with tremelimumab and/or chemotherapy (AEGEAN, PACIFIC-2, NEPTUNE, POSEION, ADRIATIC and CASPIAN Phase III trials).
About AstraZeneca’s Approach to Immuno-Oncology (IO)
Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumors. At AstraZeneca, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumor immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the clear majority of patients.
We are pursuing a comprehensive clinical trial program that includes IMFINZI (anti-PD-L1) as monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumor types, stages of disease, and lines of therapy. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and from our research partners, may provide new treatment options across a broad range of tumors.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in hematology.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.