ONO PHARMACEUTICAL : Opdivo (nivolumab) First PD-1 Inhibitor to Demonstrate Superior Overall Survival Versus Standard of Care (docetaxel) in Previously-Treated Non-Squamous Non-Small Cell Lung Cancer in Pivotal Phase III Trial(213KB)

June 3, 2015

Opdivo (nivolumab) First PD-1 Inhibitor to Demonstrate Superior Overall Survival

(PRINCETON, NJ, May 29, 2015) - Bristol-Myers Squibb Company (NYSE: BMY) announced that Opdivo (nivolumab) is the first PD-1 inhibitor to demonstrate superior overall survival versus standard of care (docetaxel) in an open-label, randomized Phase III study (CheckMate -057) evaluating previously-treated patients with advanced, non-squamous non-small cell lung cancer (NSCLC). A 27% reduction in the risk of progression or death - the primary study endpoint - was reported for Opdivo (n=292) versus docetaxel (n=290) based upon a hazard ratio of 0.73 (96% CI, 0.59-0.89; P = 0.0015). Opdivo was associated with a doubling of overall median survival across the continuum of PD-L1 expression, starting at 1% level of expression, in the trial. The safety profile of Opdivo in CheckMate -
057 was favorable versus docetaxel with grade 3-5 treatment-related adverse events reported in 10% of patients who were treated with Opdivo versus 54% in the docetaxel arm.
Through the collaboration agreement entered into in September 2011 between ONO and BMS, ONO granted BMS exclusive rights to develop and commercialize Opdivo in the rest of the world, except in Japan, Korea and Taiwan where ONO had retained all rights to develop and commercialize the compound. In July 2014, ONO and BMS signed a new collaboration agreement in which the companies agreed to jointly develop and commercialize Opdivo, ipilimumab and three early-stage immunotherapies in Japan, South Korea and Taiwan.
In USA, Opdivo was approved under accelerated approval for the treatment of unresectable or
metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor in December 2014 and approved for the treatment of metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March 2015. Also, BMS has a robust clinical development program in a variety of tumor types overseas, including: Renal Cell Carcinoma (RCC), Head and Neck Cancer, Blood Cancer, Glioblastoma, Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Hepatocellular Carcinoma, Triple-Negative Breast Cancer, Small-Cell Lung Cancer, Bladder
Cancer. In Japan, ONO launched it for the treatment of unresectable melanoma in September 2014. Also, ONO is conducting clinical development programs including RCC, NSCLC, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma and Hodgkin Lymphoma.
Attached from the following page is the press release made by BMS for your information.
Contact
ONO PHARMACEUTICAL CO., LTD. Corporate Communications public_relations@ono.co.jp

Opdivo (nivolumabF) irsPt D-1InhibitotrDo emo nstratSeuperioOr veralSlurvivaVl ersus

 CheckMate -057 demonstrates clear role for PD-L1 expression in non-squamous NSCLC; PD-L1 expressers (>1%) associated with doubling of median overall survival (17 to 19 months) compared with standard of care (8 to 9 months)
 Opdivo demonstrated similar efficacy and favorable tolerability profile versus standard of care in PD-L1 non-expressers
 Opdivo decreased risk of progression or death by 27% compared to standard of care
 Safety and tolerability profile of Opdivo is consistent with prior studies and favorable versus current standard of care
 Marks second positive Phase III trial for Opdivo in previously-treated NSCLC
(PRINCETONN, JM, a2y92,015) - Bristol-MyerSsquibCbompany (NYSEB: MYt)odayannounced that Opdivo(nivolumabit)shfeirsPtD-1inhibitotrodemonstratseuperioorveralslurvivavlersus standardocfar(edocetaxeli)naonpen-labelr,andomizedPhasIeIsItudy(CheckMat-e057e)valuating
previously-treatedpatientws ithadvancedn,on-squamounson-smalclellluncgance(rNSCLC)A2. 7% reductionitnhreiskopfrogressionodreatth-hperimarystudyendpoinw-t arseportedfor Opdivo (n=292v)ersudsocetaxe(ln=290b)asedupohnaazard ratio0f.73(96%CI0,.59-0.89P=0; .0015). Opdivowaasssociatedwitdhaoublingoofveralml ediansurvivaalcrostshceontinuumoPfD-L1 expressions,tartinga1t%leveolefxpressioni,nthterialT. hseafetyprofiloef OpdivoinCheckMat-e
05w7 afsavorablveersudsocetaxel with grad3e-5treatment-relateaddverseventrseportedin10%of patientws howertereatewd ith Opdivoversu5s4%inthdeocetaxealrm.
Thesdeatwa ilblfeeaturedtodayM, ay29, durintgh5e1sAt nnuaMl eetinogtfhAe merican SocietoyCf linicaOl ncolog(ASCOp)resbsriefinag1t:002-:00PMCDTanpdresentedurinag clinicaslciencseymposiumonSaturdayM, a3y0from8:51-9:0A3 MCDT(LatBe reakingAbstract
#109).
"CheckMat-e057resultrseportedtodaymarak
milestonienthdeevelopmenotnfewtreatment
optionfsolrungcancera,s OpdivoitshfeirsPtD-1inhibitotroshowsaignificanitmprovemenitn overalslurvivailPnahasIeItIriailnon-squam ounson-smalclelllungcancecromparedwiththe currensttandardocfared,ocetaxel,s"aidLuiPs az-AresM, DH, ospitaUl niversitariDo ocdeOe ctubre,
MadridS,pain".Ougroawl ithclinicaclancerresearchitsoalwaylsookfonrewoptiontshamt ay improvuepono,irnsomceaserseplacec,urrensttan dardocfareT. hCe heckMat-e057resultrsepresent progrestsowardestablishinngaewstandardocfartehamt ayreplacdeocetaxeilnPD-L1expressers."
Lungcanceirtshleeadingcausoecfancedreathgsloballyr,esultingimn ortehan1.5million
deathesacyheara,ccordingtothWe
orldHealthOrganizationL. ungcancerresultismn ordeeaths
worldwidtehancolorectalb,reasatndprostatceancer
csombinedN. on-smalclelllungcanceiorsnoef
thme osctommontypeostfhdeiseasaendaccountfsoarpproximately85%ocfasesS.urvivarlatevsary dependingonthsetagaendtypoetfhceancewr heniidtsiagnosed.
"ThseurvivarlesultfsromthiPshasIeItIria la,ws elalfsromCheckMat-e01i7nsquamous NSCLCv,alidattehBe ristol-MyerSsquibbdevelopmensttrategyfor Opdivotoimprovseurvival expectationfsopratientws ithlungcancer,s"aidMichaeGl iordanos,eniovricperesidentH, eadof
DevelopmentO, ncologyB, ristol-MyerSsquibb".ThCe heckMat-e057resultdsefinedthreolfeoPrD- L1expressionb,aseduponanoveralslurvivaelndpoinatnshdowedthaptatientws hosteumor
expressedPD-L1a1t%ogrreatelrevelaschievedaoublinogovferalslurvival. Thirsepresentas significanstcientifiacdvancien non-smalclelllungcancer."

AbouCt heckMat-e057

CheckMat-e057ilasandmarkPhasIeIIo,pen-labelr,andomizedclinicatlriatlhaetvaluated patientws ithadvancendon-squamouNs SCLCwhhoapdrogressedurinogarfteornperioprlatinum doublet-basedchemotherapryegimenT. hteriailncludedpatientrsegardlesostfheiPr D-L1status.
Secondaryendpointisncludedobjectivreesponsreate, progression-freseurvivaalndefficacybytumor
PD-L1expressionP.atientesnrolleidnthteriawl eraedministered Opdivo3mg/ke versusstandardocfared,ocetaxela7,t5mg/m2evertyhrewe eeks.
verytwoweeks
Ian
dditiotoimprovinogveralslurvival, Opdivodemonstratesdauperioorbjectivreesponse
ratoe1f9%versu1s2%fodrocetaxe(lP=0.0246). Thme ediandurationorfesponsfeor Opdivowas
17.2monthvsersu5s.m6 onthfsodrocetaxela,ndmediantimteoresponsoe2f.1monthvss2..6months, respectively.
CheckMat-e057alsoevaluatedthefficacyof OpdivobytumoPrD-Le1xpressionO. f randomizedpatients7,8%(455/582h)adtumosrampleasllowingthaessessmenotPfD-L1expression. RateosPfD-L1expressintumorws erbealancedbetweengroupsA. crospsre-specifie1d%5,%a,nd
10%expressionlevelsP,D-L1statuws apsredictivfeobrenefiftrom OpdivoI.pnatientws ithPD-L1 expressingtumors, Opdivodemonstratedimprovedefficacyacrosaslelndpointasatlelxpressiolevels (charbtelow).

Thseafetpyrofiloef OpdivoinCheckMat-e057wacsonsistenwt itphriosrtudieasnfdavorable versudsocetaxelS.afetprofilaelsowassimilaarcrosesxpresserasnndon-expressersT. reatment- relatedadverseventws erleowinseveritywith Opdivo andoccurredlesfsrequently(anygrade6:9%; grad3e-41:0%t)hadnocetaxe(lanygrade8:8%g;rad3e-45:4%)i,ncludingbothematologiacnd
non-hematologitcoxicitiesT. reatment-relatedseriouasdverseventws erreeportedlesfsrequentlywith Opdivo(anygrade7:.3%g;rad3e-45:.2%t)handocetaxe(lanygrade2:0%g;rad3e-41:8%). Discontinuationduteotreatment-relatedadverseventws alsesfsrequenwt ith Opdivo(5%t)han docetaxe(l15%).

ProvenEfficacAy crosHs istologieisnLungCancer

CheckMat-e05i7tshseeconpdositivPehasIeItIr iatlodemonstratseuperioorveralslurvivaflor Opdivoinon-smalclelllungcancerE. arlietrhiyseart,hPehasIeICI heckMat-e017triawl asstopped earldyuteosuperioorveralslurvivavlersudsocetaxeilnpreviously-treatedadvancedsquamounson-
smalclellluncancearnformedthbeasiostfhceompany'fsirsitndicatioinlungcancefromthUe .S. Food&DrugAdministration'(sFDAa)pprovaflor OpdivoT. riarlesultfsromCheck Mat-e017wilble presentedaAt SCOduringanor albstracstessioonnSundayM, ay31from4:304-:4PMCDT
(Abstrac#t8009).

About Opdivo

Bristol-MyerSsquibhbabasroadg,lobadlevelopmenptrogramtostudy Opdivoinmultiple
tumotrypecsonsistingomf ortehan50trial-asms onotherapoyirncombinatiown
ithothetrherapie-s
iwn
hichmortehan8,00patienthsavbeeenenrolledworldwide.

Opdivo becamtehfeirsPtD-1immunceheckpoinitnhibitotroreceivreegulatoryapproval

anywherienthwe orldonJuly42,014whenOnoPharmaceuticaCl oa.nnouncedthairtteceived
manufacturinganmd
arketingapprovailnJapanfotrhtereatmenotpfatientws ithunresectable
melanomaI.nthUe .St.,hFeDAgranteditfsirsatpprovaflor Opdivofotrhtereatmenotpfatientws ith unresectabloemr etastatimc elanomandiseasperogressionfollowing Yervo(yipilimumaba)ndi,f BRAFV600mutationpositiveBa, RAFinhibitorO. nMarch42,015, OpdivoreceiveditsecondFDA approvaflotrhtereatmenotpfatientws ithmetast atiscquamounson-smalclelllungcance(rNSCLC) withprogressiononoarfteprlatinum-basedchemotherapy.

 Severpeneumonitiosirnterstitiallundgisease, includingfataclaseso,ccurredwithOPDIVO

treatmentA. crostshcelinicatlriaelxperiencien 691patientws itsholidtumorsf,atailmmune- mediatedpneumonitiosccurredi0n.7%(5/691o)pfatientrseceivingOPDIVOn;ocases
occurrediT
ria3lI.nTria3li,mmune-mediatedpneumonitiosccurredin6%(7/117o)pfatients
receivinOg PDIVOincludingfivGe rad3aentdwoGradc2easesM. onitopratientfsosrignasnd symptomospfneumonitisA. dministecrorticosteroidfsoGr rad2oegrreateprneumonitis. PermanentlydiscontinuOe PDIVOfoGr rado3er 4anwd ithholOd PDIVO untirlesolutionfor
Grad2e.

 InTria3ld,iarrheoaccurredi2n

1%(24/117o)pfatientrseceivinOPDIVOG. rad3iemmune-
mediatedcolitiosccurredin0.9%(1/117o)pfatientsM. onitopratientfsoirmmune-mediated colitisA. dministecrorticosteroids foGr rad(2eomf ortehad5naydsuration)3o,,4crolitis. WithholdOPDIVOfoGr rado2e3rP.ermanentldyiscontinuOe PDIVOfoGr rad4ceolitiosr recurrenctolitiusponrestartingOPDIVO.

 InTria3lt,hiencidenceosifncreaseldivetresvtaluews erAe ST(16%)a,lkalinpehosphatase

(14%)A, LT(12%)a,ntdotablilirubin(2.7%)M. oni topratientfsoarbnormallivetrestpsriotro anpderiodicalldyuringtreatmentA. dministecrort icosteroidfsoGr rado2egrreatetrransaminase
elevationsW.
ithholdOPDIVOfoGr rad2aenpdermanentlydiscontinuOe PDIVOfoGr rad3oer
4immune-mediatedhepatitis.

 InTria3lt,hiencidencoeeflevatedcreatininwe a2s2%I.mmune-mediaterdenadlysfunction (Grad2eo)ccurreidn0.9%(1/117o)pfatientsM. onitopratientfsoerlevatedserumcreatinine priotroandperiodicallyduringtreatmentF.oGr rad2oe3srerumcreatininelevationw, ithhold OPDIVOandadministecrorticosteroidsiw;f orseninognroimprovemenotccursp,ermanently discontinuOe PDIVOA. dministecrorticosteroidfsoGr rad4seerumcreatininelevationand permanentlydiscontinuOe PDIVO.

 InTria3lh,ypothyroidismoccurredi4n.3%(5/117o)pfatientrseceivinOg PDIVO.

Hyperthyroidismoccurredin1.7%(2/117o)f patientisncludingonGe rad2ceaseM. onitor thyroifdunctiopnriotroanpderiodicallydurintreatmentA. dministehrormonreplacement therapyfohrypothyroidismI.nitiatme edicaml a nagemenftocrontroolhfyperthyroidism.

 Thfeollowingclinicallysignificanitmmune-med iatedadversreeactionosccurredin

 Basedonitms echanismoafctionO, PDIVOcancausfeetahlarmwhenadministeredtoa pregnanwt omanA. dvisperegnanwt omeontfhpeotentiarlisktfoaetusA. dvisfeemaleosf reproductivpeotentiatlouseffectivceontrace ptiodnuringtreatmenwt itOh PDIVOandfoart leas5mt onthasftetrhleasdtosoeOf PDIVO.

 IintsoktnownwhetheOr PDIVOipsresenitnhumanmilkB. ecausme anydrugsi,ncluding antibodiesa,rexcretedinhumanmilkandbecausoetfhpeotentiaflosreriouasdversreeactions inursinginfantfsromOPDIVO, adviswe omentodiscontinuber eastfeedindguringtreatment.

 InTria3ls,eriouasdversreeactionosccurredi5n9%opfatientrseceivinOg PDIVOT. hme ost frequensteriouasdversderurgeactionrseportedin ≥2%opfatientws erdeyspneap,neumonia, chroniocbstructivpeulmonarydiseasexacerbationp,neumonitish,ypercalcemiap,leural

effusionh,emoptysisa,npdain.

 Thme osctommonadversreaction(s

≥20%r)eportewd ithOPDIVOinTria3wl erfeatigue
(50%)d,yspne(a38%)m, usculoskeletaplain( 36%)d,ecreasedappetite (35%)c,oug(h32%), nause(a29%)a,ndconstipation(24%).
Please Ue .SF.ulPlrescribingInformationfoOr PDIVOavailablaet www.bms.com.

Immuno-OncologayBt ristol-MyerSsquibb

Surgeryr,adiationc,ytotoxioctrargetedtherapiehsavreepresentedthme ainstaoycfancer
treatmenotvetrhleassteveradle cadesb,ultong-termsurvivaalnd remainedelusivfeomr anypatientws itahdvancedisease.
paositivqeualitoylfifheave
Toaddrestshiusnmemt edicanleedB, ristol-Myers Squibbilseadingresearchinaninnovative fieldocfancerresearchandtreatmenktnownaIsmmuno-Oncologyw, hichinvolveasgentws hose primarymechanismitsoworkdirectlywiththbeody'ismmunseystemtofighctancerT. hceompanyis explorinvgaarietoycfompoundasndimmunotherapeutiacpproachefsopratientws itdifferenttypeosf canceri,ncludinrgesearchingthpeotentiaolcfombininIgmmuno-Oncologyagenttshattargedtifferent pathwayistnhtereatmenotcfancer.
Bristol-MyerSsquibbicsommittedtoadvancintghseciencoeIfmmuno-Oncologyw, iththgeoal ocfhangingsurvivaelxpectationasnd thwe apyatientlsivwe ithcancer.

AbouBt ristol-MyerSsquibb

Bristol-MyerSsquibbigaslobaplharmaceuticaclo mpanywhosme issionitsdoiscoverd,evelop andeliveirnnovativme edicinetshahtelpatientpsrevaiolvesrerioudsiseasesF.omr orienformation
abouBt ristol-MyerSsquibbv,isit www.bms.como,frollowuosTn witteart http://twitter.com/bmsnews.

This press release contains "forward-looking statements" as that term is defined in the Private

Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and

involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward- looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval for an additional indication in lung cancer or, if approved, that it will become commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K

for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

###

BilSlzablewski6,09-252-5864, william.szablewski@bms.com

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