Durvalumab ATLANTIC trial supports clinical activity and AstraZeneca’s overall immuno-oncology strategy

Durvalumab demonstrated clinical activity and durable responses in 3rd-line or later stage NSCLC patients; full data to be presented at a scientific congress in 2016

Durvalumab monotherapy and combination trials on track in multiple cancers, including 1st-line therapy for NSCLC, head & neck and bladder cancers

18 December 2015

AstraZeneca today provided an update on preliminary findings from the ATLANTIC trial of durvalumab as 3rd-line or later stage therapy in patients with locally advanced or metastatic programmed death ligand-1 (PD-L1) positive non-small cell lung cancer (NSCLC) that lacks epidermal growth factor receptor (EGFR) or ALK alterations. An initial analysis supports durvalumab’s clinical activity, with durable responses and an established safety profile in these difficult-to-treat patients.

ATLANTIC investigated the efficacy and tolerability of durvalumab in patients who received at least two prior systemic treatment regimens including platinum-based chemotherapy, and who have limited options for further therapy. A full evaluation of the data is ongoing and the results will be presented at a scientific congress in 2016.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “As we have seen in other studies, durvalumab has demonstrated expected clinical activity and durable response in these heavily pre-treated patients. As previously communicated, the treatment and regulatory landscape in lung cancer is evolving. We now believe it is unlikely that ATLANTIC can be used for regulatory submission as a monotherapy, but we will make that determination following a full analysis of the data. Durvalumab is a cornerstone of our immuno-oncology portfolio with a fast advancing development programme focused primarily on novel combinations.”

A comprehensive durvalumab registration programme is underway across multiple tumour types, stages of disease, and lines of therapy both as monotherapy and in combination. This forms part of AstraZeneca’s late-stage immuno-oncology programme and includes more than 9,000 patients in 16 clinical trials in lung, bladder, head & neck, and other cancers, summarised below.

DURVALUMAB DEVELOPMENT PROGRAMME

Status as of Year-To-Date and Q3 2015 Financial results on 5 November 2015

Next update with FY 2015 Results on 4 February 2016

LUNG CANCER

Name

Phase

Line of treatment

Population

Design

Timelines

Status

Early disease

Monotherapy
ADJUVANT III N/A Stage Ib-IIIa NSCLC durvalumab vs placebo Data expected 2020 Recruiting
PACIFIC
III N/A Stage III unresect-able NSCLC durvalumab vs placebo Data expected 2017 Recruiting
Advanced/metastatic disease
Monotherapy
ATLANTIC II 3rd line PD-L1 pos. NSCLC durvalumab (single arm) Full data 2016 -
Combination therapy
ARCTIC III 3rd line NSCLC durvalumab vs SoC (PD-L1 pos.) or durvalumab vs tremelimumab vs durva + treme vs SoC (PD-L1 neg.) Data expected 2017 Recruiting
MYSTIC III 1st line NSCLC (PFS endpoint) durvalumab vs durva + treme vs SoC Data expected 2017 First patient dosed
NEPTUNE III 1st line NSCLC (OS endpoint) durva + treme vs SoC Data expected 2018 Awaiting first patient dosed
- III 1st line NSCLC durvalumab + chemotherapy +/- tremelimumab   In preparation
CAURAL III 2nd line T790M+ NSCLC osimertinib vs osimertinib + durvalumab Data expected 2018 Initiated enrolment; currently on partial clinical hold to characterise incidence of interstitial lung disease

METASTATIC HEAD AND NECK CANCER

Name

Phase

Line of treatment

Population

Design

Timelines

Status

Monotherapy
HAWK II 2nd line PD-L1 pos. SCCHN durvalumab (single arm) Data expected
H2 2016
Recruiting

Indication granted FDA Fast Track designation
Combination therapy
CONDOR II 2nd line PD-L1 neg. SCCHN durvalumab vs tremelimumab vs durva + treme Data expected 2017 Recruiting
EAGLE III 2nd line SCCHN durvalumab vs durva + treme vs SoC Data expected 2018 In preparation
KESTREL III 1st line SCCHN durvalumab vs durva + treme vs SoC Data expected 2018 In preparation

METASTATIC BLADDER CANCER

Name

Phase

Line of treatment

Population

Design

Timelines

Status

DANUBE III 1st line Cisplatin chemo-therapy-eligible/ineligible durvalumab vs durva + treme vs SoC
Data expected 2018

First patient dosed

OTHER TUMOUR TYPES

Name

Phase

Line of treatment

Indication

Design

Timelines

Status

- II 2nd/3rd line Metastatic gastric cancer durvalumab vs tremelimumab vs durva + treme



In preparation
- II 2nd line Unresect-able liver cancer durvalumab vs tremelimumab vs durva + treme   In preparation
ALPS II 2nd line Unresect-able liver cancer durva + treme (single arm)   In preparation

SoC = Standard of Care, PFS = Progression Free Survival, OS = Overall Survival

NOTES TO EDITORS

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against PD-L1. Signals from PD-L1 help tumours avoid detection by the immune system. Durvalumab blocks these signals, countering the tumour's immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient's immune system and attack the cancer. Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with tremelimumab, in NSCLC, head and neck, gastric, pancreatic, bladder and blood cancers.

About the ATLANTIC trial

ATLANTIC is a Phase II, non-comparative, open-label, multi-centre, international trial of durvalumab in patients with locally advanced or metastatic NSCLC (Stage IIIB-IV) who have received at least two prior systemic treatment regimens including one platinum-based chemotherapy regimen.

About AstraZeneca in Oncology

Oncology is a therapy area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as a cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas – lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com.

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