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AstraZenecaAnnouncement

29/02/2016 13:50

RNS Number : 4923Q
AstraZeneca PLC
29 February 2016
ASTRAZENECAREPORTSTOP-LINERESULT OF TREMELIMUMAB MONOTHERAPYTRIAL INMESOTHELIOMA
Trial didnot meet primaryendpointof improvingoverall survival in challenging to treat mesothelioma patientswith no currently approved treatmentoptions in the second-line setting
Tremelimumabremainskeycomponent of Immuno-Oncologycombinationstrategy across multipletumourtypes
AstraZenecaand MedImmune, itsglobal biologics researchand development arm, today announced thatDETERMINE,thePhaseIIb clinical trial of10 mg/kgtremelimumab monotherapy in secondorthird-linetreatmentof unresectablemalignantmesothelioma,did not meet itsprimaryendpointofoverall survival.
Robert Iannone,SeniorVice President, Head of Immuno-Oncology, Global Medicines DevelopmentatAstraZeneca,said:"Wearedisappointed that tremelimumabmonotherapy did notdemonstrate asurvival benefit inthispatientpopulationwith noapproved medicines beyond first-line treatment. However,we remainconfidentintremelimumab'sclinicalactivity incombination, as shownin our recentlypublished Study006 trialoftremelimumab and durvalumabin non-small cell lung cancer."
In additionto investigationasmonotherapyforpatientswith mesothelioma, tremelimumab is beingstudiedin combination with AstraZeneca'santi-PD-L1 investigational immunotherapy durvalumabin multiple tumour types,includingnon-small cell lungcancer (NSCLC), squamouscell carcinoma ofthehead andneck,bladder,pancreatic, gastricandliver cancers.Preclinical data have suggestedthat targeting bothPD-L1and CTLA-4mayhave additive orsynergisticeffects.1Inthe recentlypublished Study006,combination treatment with durvalumabandtremelimumabdemonstrated antitumour activity in patientswith locally advanced ormetastaticNSCLC,irrespective ofPD-L1 status.2
TheCompanywill completeafull evaluation ofthefinalDETERMINEdata,which will be submitted for presentation at an upcoming medical meeting in 2016.
1Stewartet al.Preclinicalmodeling ofimmune checkpointblockade(P2012).JImmunol2013: 190(1Meeting
Abstracts):Abstract 214.7.
2AntoniaS,et al.SafetyandantitumouractivityinaPhase1b studyofcombinedcheckpoint blockade with anti- PD-L1(durvalumab) and anti-CTLA-4(tremelimumab) innon-smallcelllungcancer.TheLancetOncology.Available at http://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(15)00544-6.pdf.Accessed February 2016.
3DelgermaaVetal.Globalmesothelioma deathsreportedtotheWorldHealthOrganizationbetween 1994and
2008.BullWorldHealthOrgan. 2011Oct1;89(10):716-24,724A-724C
4DriscollTet al.The globalburden ofdiseaseduetooccupationalcarcinogens.AmJ IndMed.2005
Dec;48(6):419-31.
AboutMesothelioma
Mesotheliomaisarareand deadly formofcancerthataffectstheliningof the lungs or abdomen.Thereisahigh unmetmedical needfor mesothelioma treatments, withmedian overall survival 9 to12 monthsafterinitial diagnosis.3Thediseasecausesapproximately 43,000 deaths peryearglobally.4In 2015, tremelimumabwas grantedOrphan DrugDesignationbythe U.S. Food and Drug Administration.
Aboutthe DETERMINEtrial
DETERMINE (NCT01843374)isarandomised, double-blind,placebo-controlledPhaseIIb global trial with571patientsacrossmultiple countries. Thetrial evaluated the safetyand efficacyoftremelimumab versusplacebo inthetreatmentofunresectablepleural or peritonealmalignantmesothelioma.
AboutTremelimumab
Tremelimumab isan investigational,selective human antibodydirectedagainstcytotoxicT- lymphocyte-associatedprotein 4(CTLA-4). Byblocking theactivityofCTLA-4, tremelimumab "releasesthe brakes"onT cell activation and booststheimmuneresponse againstcancercells.Tremelimumabisbeinginvestigated inan extensive clinical trial programme,asmonotherapyorincombinationwith durvalumab,in NSCLC,bladder,head and neck,gastric,pancreatic,HCC andblood cancers. In2015, the U.S. Food and Drug AdministrationgrantedtremelimumabFastTrackDesignation andOrphanDrug Designation as apotentialtreatment formalignant mesothelioma,an aggressive,rareform ofcancer that affectstheliningof the lungsand abdomen.
AboutDurvalumab
Durvalumabisan investigational humanmonoclonal antibodydirectedagainstprogrammed death ligand-1(PD-L1).PD-L1 expression enables tumoursto evade detectionfrom the immunesystemthroughbindingtoPD-1on cytotoxicTlymphocytes. Durvalumabblocks PD-L1 interaction with bothPD-1and CD80onT cells,countering thetumour's immune- evadingtactics. Durvalumabisbeing developed alongside other immunotherapies to activate thepatient's immune system toattack the cancer.Durvalumabisbeinginvestigated in anextensive clinical trial programme, asmonotherapyorincombinationwith tremelimumab,in NSCLC,bladder,headand neck, gastric,pancreatic, HCC and blood cancers. In 2015,durvalumabreceived Fast TrackDesignationforthetreatmentofpatients with PD-L1-positive metastatic SCCHN,and in 2016,durvalumabwas granted BreakthroughDesignation bythe U.S. Food andDrug Administrationas apotential treatment formetastaticurothelial bladdercancer.
AboutAstraZeneca inOncology
AstraZenecahasa deep-rooted heritage inOncologyand offersaquicklygrowingportfolio ofnewmedicinesthat has thepotential totransformpatients' lives and theCompany's future.Withat least 6 newmedicines to be launched between 2014 and2020 and abroad pipeline ofsmallmolecules and biologicsin development,we arecommitted toadvance New Oncologyas oneofAstraZeneca'ssixGrowth Platformsfocused on lung, ovarian,breast and blood cancers. Inaddition to our corecapabilities,we activelypursue innovative partnerships andinvestmentsthat acceleratethe deliveryofourstrategy,asillustratedby ourinvestmentin AcertaPharmain haematology.
Byharnessing thepowerof fourscientificplatforms--immuno-oncology, thegenetic drivers ofcancerand resistance,DNA damagerepairand antibodydrug conjugates--andby championing thedevelopment ofpersonalised combinations, AstraZenecahasthe vision to redefine cancer treatmentandone dayeliminate cancerasacause ofdeath.
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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology - as well as in infection and neuroscience. 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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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, 
ING - Infection, Neuroscience and Gastrointestinal
29 February 2016
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