ONO PHARMACEUTICAL : Follow-up Data from Two Pivotal Opdivo (nivolumab) Trials Demonstrates Sustained Survival Results in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer (154KB)

September 11, 2015

(PRINCETON, NJ, September 7, 2015) - Bristol-Myers Squibb Company (NYSE: BMY) announced longer term survival and safety data from CheckMate -017 and -063, two pivotal trials evaluating Opdivo in previously treated squamous (SQ) non-small cell lung cancer (NSCLC), showing sustained survival benefit across these studies. In both trials, Opdivo showed an estimated 18 month overall survival (OS) rate of 27% (CheckMate -063) to 28% (CheckMate -017); survival benefit was independent of PD-L1 expression. The safety profile of Opdivo is consistent with previously-reported trials, and in CheckMate -017, is also favorable compared to docetaxel. These data was presented at the
16th World Conference on Lung Cancer (Abstract #736, CheckMate -017 and #828, CheckMate -063).
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. In EU, Opdivo was approved for the treatment of advanced (unresectable or metastatic) melanoma in adults regardless of BRAF status in June 2015. European Commission approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy in July 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, Urothelial 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, Hodgkin Lymphoma, Urothelial Cancer and Glioblastoma.
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

Clinical benefit observed among both PD-L1 expressors and non-expressors, across both trials

Safety and tolerability profile at 18 month follow-up is consistent with previously-reported results from these trials

(PRINCETONN, JS,eptembe7r2,015) - Bristol-MyerSsquibCbompany (NYSEB: MY) today announcedlongetrermsurviv alnsdafetydatfaromCheckMat-e01a7nd-063t,wopivotatlrials

evaluating Opdiviopnreviouslytreatedsquamou(sSQn)on-smalclelllungcance(rNSCLC)s,howing sustainedsurvivablenefiatcross thessetudiesI.bnotthrials, Opdivoshowedanestimated18month overalslurviva(lOSr)atoe2f7%(CheckMat-e063t)o28%(CheckMat-e017)s;urvivablenefiwt as
independenotPfD-L1expressionT. hseafetyprofiloef Opdivo icsonsistenwt itpreviously-reported
trialsa,ndinCheckMat-e017ia,slsfoavorablceomp aretddoocetaxelT. hesdeatwa ilblperesented
todayatth1e6 tWh
CheckMat-e063).
orldConferencoenLungCance(rAbstrac#t736C, heckMat-e017an#d828,
"Immuno-Oncologyagentlsike Opdivo providnaeovealpproachttreatingcancer. The improvemenitnsurvivaolbservedinadvancedsquamounson-smalclelllungcancerrepresentasn
importansttepforwarfdorupratients,s"aiSureshSR. amalingamM, .Dd.,irectorD, ivisionof
MedicaOl ncologyW,
inshipCanceIrnstitutoeEf moryUniversity".Thesuepdatedresultdsemonstrate
thaebilitytoachievleongetrermsurvivaolutcomeisnthipsatienptopulationI.nfacthKe aplan-Meier curvferomthisstudysuggestpasrolongesdurvivablenefiftosarubseotpfatients."
Previously-reportedonyeearresultfsromChec kMat-e017showesdaignificantlysuperioOr S
ratoe4f2%versu2s4%fodrocetaxelI.nCheckMat-e063t,hestimatedone-yeasrurvivarlatwe a3s9%. (seteablbeelow)

"OuarpproacthoImmuno-Oncologyresearchiisntendedtoshowmeaningfuilmprovement ovetrhteraditionasltandardocfaroenthbeenchmarkendpoinotofveralslurvival ,s"aidMichael Giordanos,eniovricperesidenth,eadoDf evelopmentO, ncology".Wheavteakecanomprehensive
researchapproachilnungcancero,nfeocusedocanommitmenttoprovidingthfeirsmt ajor
advancemenitnsquamounson-smalclellungcanceirnmortehadnaecad-e

Opdivo-thaotffertshe

potentiatloreplaccehemotherapyW.
itthhdeatpar esentetdodayw, reemainconfidenitnouIrmmuno-
Oncologystrategyi,ncludingfulfillinogur goailnshowintghseurvivablenefiftor Opdivon,ootnlyin
non-smalclellluncancerb,ustimilatrtohdeatalreadoybservedian tumotrypes."

About CheckMate -017 & CheckMate -063

dvancedmelanomanodther
CheckMat-e01a7
ndCheckMat-e063demonstratedthefficacyandsafetyof Opdivoipnatients
withadvancedomr etastatiScQNSCLCwhhoapdrogressedfollowingprevioucshemotherapy treatmentT. ogethert,hterialisnvestigated Opdivo monotherapyadatosoe3mf g/kegverytwwo eeks,
whichabseewn ell-establishedacrostshPehas3e

Opdivo clinicadlevelopmenptrogramfsovrarious

tumorsT. hesterialaslsoformedthbeasifsor Opdivo'aspprovalisnthUe .Sa.ndEuropeanUniona,nd helpedtoestablishthaegenatsstandardocfarfeoprreviouslytreatedSQNSCLC.
CheckMat-e017ilasandmarkPhas3eo,pen-labelr,andomizedclinicatlriatlhaetvaluated

Opdivo (n=1353)mg/kigntravenouslyove6r0minuteesverytwoweekvsersusstandardocfare,

docetaxe(ln=1377)5mg/m
i2ntravenouslyadministeredeverythrewe eekisnpatientws ithadvanced
SQNSCLCwhhoapdrogresseduringoarfteornperioprlatinumdoublet-basedchemotherapy regimenT. hsetudy'psrimaryendpoinwt aOs San dsecondaryendpointisncludedprogression-free surviva(lPFSa)nodbjectivreesponse rat(eORR)T. hteriailncluded patientrsegardlesostfheiPrD-L1 expressiosntatus.
CheckMat-e017showedaoublingin18monthOSbenefiwt itahnestimated28%opfatients
alivae1tm8 onthfsor Opdivoversu1s3%fodrocetaxelT. hme edianOSfotrhe Opdivoarmwa9s.2 monthasn6d.0monthfsodrocetaxe(lhazarrdatio0:.6[295%CI0,.480,.81P=0; .0004])I.naddition,

Opdivo showesadtatisticallysignificanitmprovemen

itnPFSanOd RRT. hPeFSrataet1m8 onthws as
17%fotrhe Opdivoarmversu2s.7%fodrocetaxelM. edianPFSwa3s.m5 onthfsopratients administered Opdivo versu2s.8monthfsodrocetaxe(lhazardratio0:.63[;95%CI0,.480,.83P=;
0.0008])T. hOe RRwa2s0%fotrhe Opdivo armversu9s%fodrocetaxefloarnestimatedoddrsatiof
2.6(95%CI1,.35,.5P=0; .0083)w, ithanongoinrgesponsseeenin63%opfatienttsreatedwith

OpdivoI.tnhterial2,p8ati entws ertereatedwith Opdivobeyondinitiaplrogressiona,ndnine demonstratendaon-conventionaplatteronbfenefi(t7%)T. hseafetyprofiloef Opdivocontinuetdboe favorablveersudsocetaxealndtreatment-relatedAEosccurreldesfsrequentlywith Opdivo(n=131a;ny grade5,9%g;rad3e-58,%n;ograd5eventst)handocetaxe(ln=129a;nygrade8,7%g;rad3e-55,8%), includinbgothematologiacnndon-hematologitcoxicitiesT. hme ajoritotfreatment-relatesdelecAt Es inpatientrseceiving Opdivo occurredwithinthfeirstthreme onthostfreatment.

CheckMat-e063iPashas2es,ingle-armo,pen-label triatlhaitncludedpa tientws itmh etastatic SQNSCLCwhohadprogressedafterreceivinpgalatinum-basedtherapyandalteasotnaedditional systemitcreatmenrtegimen(n=117)I.nthitsrial, Opdivo showedanestimated18-monthOSratoef
27%A.1t8monthsc,onfirmedobjectivreesponsreatet,hsetudy'psrimaryendpointw, a1s5%(95%CI:
92,2)M. ediaOn Swa8s.1month(s95%CI6:.11,0.9)M. osttreatment-relatedAEws eroelfowgrade
(anygrade7,5%g;rad3e-41,7%a)ndmanagedusingestablishedtreatmenatlgorithms .

About Lung Cancer

Lungcanceitrshleeadincausoecfancedreathgsloballyr,esultinginmortehan1.m5 illion
deathesacyheara,ccordintgtohWe
orldHealthOrganizationL. uncgancerresultisnmordeeaths
worldwidtehancolorectalb,reast andprostatceancercsombinedN. on- smalclelllungcance(rNSCLC)
iosnoetfhme osctommontypeostfhdeiseasaendaccountfsoarpproximately85%ocfasesS.quamous celNl SCLCaccountfsoarpproximately25%to30%oaflungcancecrasesF.ivyeeasrurvivarlates
varygloballdependinognthsetagaentdypoelfuncg
ancer.

About Opdivo

Bristol-MyerSsquibhbabasroadg,lobadlevelopmenptrogramtostudy Opdivo inmultiple
tumotrypecsonsistingomf ortehan50trial-asmas onotherapyoircnombinatiown
itohthetrherapies
-iwn
hicmh ortehan8,00p0atienthsavbeeenenrolledworldwide.

Opdivo ipasrogrammedeath-(1PD-1i)mmunceheckpoinitnhibitotrhahtarseceivedapproval

fromthFeDAamas onotherapyintwocanceirndications. OpdivobecamtehfeirsPtD-1immune checkpoinitnhibitotrroeceivreegulatoryapprov alnywherietnhwe orldoJnuly42,014whenOno PharmaceuticaCl oa.nnouncedthairteceivedmanufacturingandmarketingapprovailnJapanfotrhe
treatmenotpfatientws ituhnres ectablme elanomaI.nthUe .St.,he FooadndDrugAdministratio(nFDA)
granteidtfsirsatpprovaflor Opdivofotrhtereatmenotpfatientws ithunresectabloemr etastatic melanomandiseasperogressionfollowing Yervo(yipilimumaba)ndiB,f RAFV600mutationpositive, Ba RAFinhibitorO. nMarch42,015, OpdivroeceiveditssecondFDAapprovaflotrhtereatmenotf
patientws ithmetastatiscquamou(sSQn)on-small celllungcance(rNSCLC) withprogressioonnor
afteprlatinum-basecd
hemotherapyO. nJuly20t,hEe uropeanCommissionapproveNd ivolumaBb MS
fotrhtereatmenotlfocallyadvancedomr etastatiScQNSCLCafteprriocrhemotherapy.

OPDIVO®(nivolumabi)isndicatedfotrhtereatmenotf patientws ithmetastatiscquamounson-small celllungcance(rNSCLCw) ithprogressiononoarfteprlatinum-basedchemotherapy.

mediatedpneumonitiosccurredi0n.7%(5/691o)pfatientrseceivingOPDIVOn;ocases
occurrediTn
ria1olTr ria3lI.nTria1lp,neumonitisi,ncludinginterstitiallundgiseaseo,ccurred
i3.4%(9/268o)pfatientrseceivinOg PDIVOanndonoetfh1e02patientrseceiving chemotherapyI.mmune-mediatedpneumonitiosccurredin2.2%(6/268o)pfatientrseceiving OPDIVOo;nwe ithGrad3aendfivwe ithGrad2eI.nTria3li,mmune-mediatepdneumonitis occurredin6%(7/117o)pfatientrseceivingOPDIVOi,ncludingf,ivGe rad3aendtwoGrad2e caseMs.onitopratientfsosrignasndsymptoms opfneumonitisA. dministecrorticosteroidfsor Grado2egrreateprneumonitisP.ermanently discontinuOe PDIVOfoGr rado3ea4rnd withholdOPDIVOuntirlesolutionfoGr rad2e.

 InTria1ld,iarrheoacrolitiosccurreidn21%(57/268o)pfatientrseceivingOPDIVOand18% (18/102o)pfatientrseceivingchemotherapyI.m mune-mediatedcolitiosccurredi2n.2%(6/268)
opfatientrseceivinOPDIVOf;ivwe itGrad3aenod
nwe ithGrad2eI.nTria3ld,iarrhea
occurredi2n
1%(24/117o)pfatientrseceivinOg PDIVOG. rad3iemmune-mediatedcolitis
occurredin0.9%(1/117o)pfatientsM. onitopratientfsoirmmune-mediatedcolitisA. dminister
corticosteroidfsoGr rad2(eomf ortehand5aydsuration)3o,,c4rolitisW.
ithholdOPDIVOfor
Grado2e3rP.ermanentlydiscontinuOe PDIVO foGr rad4ceolitiosrrecurrenctolitiuspon restartingOPDIVO.

 InTria1lt,herwe aasinncreasedincidencoef livetresatbnormalitie
istnhOe PDIVO-treated
groupacsomparedtothcehemotherapy-treategdroupw, ithincreaseisnAST(28%v1s2%),
alkalinpehosphatas(e22%v1s3%)A, LT(16%v5s%)a,ntdotablilirubin(9%v0s)I.mmune- mediatedhepatitiosccurredin1.1%(3/268o)f patientrseceivingOPDIVOt;wwo itGh rad3e anodnwe ithGrad2eI.nTria3lt,hiencidenceosifncreaseldivetresvtaluews erAe ST(16%), alkalinpehosphatas(e14%)A, LT(12%)a,ndtotablilirubin(2.7%)M. onitopratientfsor abnormallivetrestpsriotroanpderiodicallyduringtreatmentA. dministecrorticosteroidfsor
Grado2egrreatetrransaminaselevationsW.
ithholdOPDIVOfoGr rad2aenpdermanently
discontinuOe PDIVOfoGr rad3oe4irmmune-mediatehdepatitis.

 InTria1lt,herwe aasinncreasedincidencoeeflevatedcreatininietnhOe PDIVO-treategdroup acsomparedtthcehemotherapy-treategdrou(p13%v9s%)G. rado2e3irmmune-mediated nephritiosrrenadlysfunctiooccurreidn0.7%(2/268o)pfatientsI.nTria3lt,hiencidencoef elevatedcreatininwe a2s2%I.mmune-mediatedrenadlysfunction(Grad2eo)ccurredin0.9% (1/117o)pfatientsM. onitopratientfsoerlevat edserumcreatininperiotraonpderiodically duringtreatmentF.oGr rad2oe3srerumcreatininelevationw, ithholdOPDIVOandadminister corticosteroidsiw;f orseninognroimprovemenotccursp,ermanentldyiscontinuOe PDIVO. AdministecrorticosteroidfsoGr rad4seerumcreatininelevationanpdermanentldyiscontinue OPDIVO.

 InTria1lG, rad1oe2hrypothyroidismoccurredi8%(21/268o)pfatientrseceivinOg PDIVO
anndonoetfh1e02patientrseceivingchemotherapyG. rad1oe2hryperthyroidismoccurredin
3%(8/268o)pfatientrseceivingOPDIVOand1%(1/102o)pfatientrseceivingchemotherapy. InTria3lh,ypothyroidismoccurredi4n.3%(5/117o)pfatientrseceivinOg PDIVO. Hyperthyroidismoccurredin1.7%(2/117o)pfatientsi,ncludingonGe rad2ceaseM. onitor thyroifdunctiopnriotroanpderiodicallydurintreatmentA. dministehrormonreplacement therapyfohrypothyroidismI.nitiatme edicaml a nagemenftocrontroolhfyperthyroidism.

 InTria1alnd3(n=385)t,hfeollowingclinical lysignificanitmmune-mediateaddversreeactions occurredin
anad
bducennservpearesisd,emyeliniationa,utoimmunneeuropathym, otodrysfunctiona,nd
vasculitisA. croscslinicatlrialosOf PDIVOadministeredadtose3ms g/kgan1d0mg/kg, additionacllinicallysignificanti,mmune-med iatedadversreeactionws eriedentified: hypophysitisd,iabetikcetoacidosish,ypopituitarismG, uillain-Barrséyndromea,ndmyasthenic syndromBea. seodnthseeveritoyafdversree actionw, ithholdOPDIVOa,dministehrigh-dose corticosteroidsa,ndia,fppropriatei,nitiatheormoner-eplacementtherapy.

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

 IintsoktnownwhetheOr PDIVOipsresenitnhumanmilkB. ecausme anydrugsi,ncluding antibodiesa,rexcretedinhumanmilkandbecausoetfhpeotentiaflosreriouasdversreeactions
inursinginfantfsromOPDIVOa,
dviswe omentodiscontinuberea stfeedindguringtreatment.

 InTria1ls,eriouasdversreeactionosccurredi4n1%opfatientrseceivinOg PDIVOG. rada3end
4adversreeactionosccurredin42%opfatientrseceivingOPDIVOT. hme osftrequenGt rad3e an4dadversderugreactionrseportedin2% t
 InTria3ls,eriouasdversreeactionosccurredi5n9%opfatientrseceivinOg PDIVOT. hme ost frequensteriouasdversderugreactionrseportedin ≥2%opfatientws erdeyspneap,neumonia, chroniocbstructivpeulmonarydiseasexacerbationp,neumonitish,ypercalcemiap,leural effusionh,emoptysisa,npdain.

 Thme osctommonadversreaction(s
≥20%r)eportewd ithOPDIVOinTria1wl erreash(21%)
anidnTriaw3l erfeatigu(e50%)d,yspne(a38%m),usculoskeletaplai(36%)d,ecreased appetit(e35%)c,ough(32%)n,ause(a29%)a,ndconstipation(24%).
Please Ue .SF.ulPlrescribingInformationfoOr PDIVOat www.bms.com.

Immuno-Oncology at Bristol-Myers Squibb

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.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

I2n011t,hrougchaollaboratioangreemenwt ithOnoPharmaceuticaCl o.B, ristol-MyerSsquibb
expandedittserritoriarlighttsdoevelopancd
ommercialize Opdivo globallyexcepitJnapanS,outh
KoreandTaiwanw, herOe nohadretainedalrlights tothceompoundatthteimeO. nJuly232,014, Bristol-MyerSsquibbandOnoPharmaceuticaflurtheerxpandedthceompaniess'trategicollaboration
agreementtojointldyevelopancd
ommercializme ultipliemmunotherapie-asssinglaegentasnd
combinatiornegimenf-sopratientws ithcanceirJnapanS,outKh oreandTaiwan.

About Bristol-Myers Squibb

Bristol-MyerSsquibbigaslobabliopharmaceuticaclompanywhosme issionitsdoiscover, develoapndeliveirnnovativme edicinetshahtelpatientpsrevaiolvesrerioudsiseasesF. omr ore informatioanbouBt ristol-MyerSsquibbv,isit www.bms.como,frollowuosnTwitteart
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. 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.

###

CarriFeernandez2,15-859-2605, carrie.fernandez@bms.com

RanyDa ajani6,09-252-5330, ranya.dajani@bms.com
BilSlzablewski6,09-252-5864, william.szablewski@bms.com

distributed by