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

Pressmeddelande   •   Dec 18, 2015 08:03 CET

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

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

PhaseLine of treatmentPopulationDesignTimelinesStatus
Early diseaseMonotherapy
ADJUVANTIIIN/AStage Ib-IIIa NSCLCdurvalumab vs placeboData expected 2020Recruiting
PACIFICIIIN/AStage III unresect-able NSCLCdurvalumab vs placeboData expected 2017Recruiting
Advanced/metastatic     diseaseMonotherapy
ATLANTICII3rd linePD-L1 pos. NSCLCdurvalumab (single arm)Full data 2016-
Combination therapy
ARCTICIII3rd lineNSCLCdurvalumab vs SoC (PD-L1 pos.) or durvalumab     vs tremelimumab vs durva + treme vs SoC (PD-L1 neg.)Data expected 2017Recruiting
MYSTICIII1st lineNSCLC (PFS endpoint)durvalumab vs durva + treme vs SoCData expected 2017First patient dosed
NEPTUNEIII1st lineNSCLC (OS endpoint)durva + treme vs SoCData expected 2018Awaiting first patient dosed
-III1st lineNSCLCdurvalumab + chemotherapy +/- tremelimumabIn preparation
CAURALIII2nd lineT790M+ NSCLCosimertinib vs osimertinib + durvalumabData expected 2018Initiated enrolment; currently on partial     clinical hold to characterise incidence of interstitial lung disease

METASTATIC HEAD AND NECK CANCER

NamePhaseLine of treatmentPopulationDesignTimelinesStatus
Monotherapy
HAWKII2nd linePD-L1 pos. SCCHNdurvalumab (single arm)Data expected H2 2016RecruitingIndication granted FDA Fast Track     designation
Combination therapy
CONDORII2nd linePD-L1 neg. SCCHNdurvalumab vs tremelimumab vs durva +     tremeData expected 2017Recruiting
EAGLEIII2nd lineSCCHNdurvalumab vs durva + treme vs SoCData expected 2018In preparation
KESTRELIII1st lineSCCHNdurvalumab vs durva + treme vs SoCData expected 2018In preparation
METASTATIC Bladder   CANCER
NamePhaseLine of treatmentPopulationDesignTimelinesStatus
DANUBEIII1st lineCisplatin chemo-therapy-eligible/ineligibledurvalumab vs durva + treme vs SoCData expected 2018First patient dosed
OTHER TUMOUR TYPES
NamePhaseLine of treatmentIndicationDesignTimelinesStatus
-II2nd/3rd line Metastatic gastric cancerdurvalumab vs tremelimumab vs durva +     treme In preparation
-II 2nd lineUnresect-able liver cancerdurvalumab vs tremelimumab vs durva +     tremeIn preparation
ALPSII2nd lineMetastatic pancreatic cancerdurva + treme (single arm)In preparation

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

– ENDS –

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.

CONTACTS

Media Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Karen BirminghamUK/Global+44 20 7604 8120
Jacob LundSweden+46 8 553 260 20
Michele MeixellUS+1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk LarsenOncology+44 20 7604 8199+44 7818 524185
Eugenia LitzRIA+44 20 7604 8233+44 7884 735627
Nick StoneCVMD+44 20 7604 8236+44 7717 618834
Craig MarksING+44 20 7604 8591+44 7881 615764
Christer Gruvris+44 20 7604 8126+44 7827 836825
US
Lindsey TrickettOncology, ING+1 301 398 5118+1 240 543 7970
Mitchell ChanOncology+1 301 398 1849+1 301 398 1849
Dial / Toll-Free+1 301 398 3251+1 866   381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

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