IMFINZI® (durvalumab) Improves Overall Survival at Interim Analysis in the Phase III CASPIAN Trial in 1st-Line Extensive-Stage Small Cell Lung Cancer

Trial showed statistically-significant and clinically meaningful benefit in patients with the most aggressive type of lung cancer

WILMINGTON, DE, USA June 27, 2019 I AstraZeneca today announced positive overall survival (OS) results from the Phase III CASPIAN trial with IMFINZI in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients.

A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial has met its primary endpoint by showing a statistically-significant and clinically-meaningful improvement in OS in patients treated with IMFINZI in combination with standard-of-care etoposide and platinum-based chemotherapy options vs. chemotherapy alone. The safety and tolerability for this IMFINZI combination was consistent with the known safety profiles of these medicines. This is the first study to show efficacy of using a fixed dose of IMFINZI (1500mg) administered every 3 weeks in combination with chemotherapy for 4 cycles and then every 4 weeks until disease progression.

AstraZeneca will submit these results for presentation at a forthcoming medical meeting.

José Baselga, Executive Vice President, Oncology R&D said: “The Phase III CASPIAN results offer new hope for patients who are facing the devastating diagnosis of small cell lung cancer, and for whom new medicines are urgently needed. This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options.”

CASPIAN is a randomized, open-label, multi-center, 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 dual immune checkpoint blockade with chemotherapy. This combination includes tremelimumab, an investigational anti-CTLA-4 antibody and potential new medicine, with IMFINZI, an anti-PD-L1 antibody, and chemotherapy.

IMFINZI is also being investigated following concurrent chemoradiation therapy in limited-stage SCLC in the PHASE III ADRIATIC trial.

IMFINZI is approved for 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.

About CASPIAN

The CASPIAN trial is a randomized, open-label, multi-center, global, Phase III trial in the 1st-line treatment of patients with extensive-stage SCLC. The trial compared IMFINZI in combination with etoposide and either cisplatin or carboplatin chemotherapy, or IMFINZI, tremelimumab and chemotherapy vs. chemotherapy alone. In the experimental arms, patients were treated with up to four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and prophylactic cranial irradiation if clinically indicated.

The trial is being conducted in more than 200 centers across 22 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint is OS.

About small cell lung cancer

Globally, lung cancer is the leading cause of cancer death and accounts for about one-fifth of all cancer deaths. Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC. About two-thirds of SCLC patients are diagnosed with extensive stage disease, in which the cancer has spread widely through the lung or to other parts of the body. SCLC is an aggressive cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy. Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.

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.

As part of a broad development program, IMFINZI is also being tested as a monotherapy and in combination with tremelimumab, an investigational anti-CTLA-4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumors.

About tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being tested in a clinical trial program in combination with IMFINZI in NSCLC, bladder cancer, head and neck cancer, liver cancer and blood cancers.

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 potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. 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. 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.

About AstraZeneca

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.

SOURCE: AstraZeneca

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