ONO PHARMACEUTICAL : Opdivo (nivolumab) Demonstrates Superior Survival Compared to Standard of Care (docetaxel) for Previously-Treated Squamous Non-Small Cell Lung Cancer in Phase III Trial(156KB)

June 2, 2015

(PRINCETON, NJ, May 31, 2015) - Bristol-Myers Squibb Company (NYSE: BMY) announced results from CheckMate -017, a Phase III, open-label, randomized study evaluating Opdivo (n=135) versus docetaxel (n=137) in previously treated patients with advanced, squamous non-small cell lung cancer. At one year, Opdivo demonstrated an overall survival rate of 42% versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. In the trial, Opdivo reduced the risk of death by 41%, based upon a hazard ratio of 0.59 (95% CI, 0.44-0.79; P = 0.00025). The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel.
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 (nivolumab) Demonstrates Superior Survival Compared to Standard of Care (docetaxel)

 Opdivo is the first major treatment advance in more than a decade showing a survival benefit in squamous non-small cell lung cancer
 In CheckMate -017, Opdivo (nivolumab) showed a superior one year overall survival rate of

42% vs. 24% for docetaxel

 Opdivo demonstrated significant superiority across all endpoints including response rate and progression-free survival versus standard of care in PD-L1 expressers and non-expressers
 Findings presented today at annual meeting of the American Society of Clinical Oncology and silmultaneouly published in the New England Journal of Medicine
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cancerA.otnyeear, Opdivo demonstrateadonveralslurvivarlatoe4f2%versu2s4%fodrocetaxel, witmah ediaonveralslurvivaol9f.m2 onthvsersum6s onthsr,espectivelyI.tnhterial, Opdivo reduced threisokdfeatbh4y1%b,aseudpohanazarrdatio0f.5(9 5%CI0,.44-0.79P=0; .00025)T. he
safetpyrofiloef Opdivo iCn heckMat-e01w7 acsonsistenwt itphriosrtudieasnfdavorablveersus docetaxelF.indingfsromCheckMat-e01w7 erpeublishetdodaiyn The New England Journal of Medicine anpdresentedurinagonraalbstracstessioantth5e1 st AnnuaMl eetinogtfhAe merican SocietoyCf linicaOl ncolog(yAbstrac#t8009).
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canceirmn ortehadanecade,s"a iDd aviSdpigeMl, DS,araCh annoRn e searcIhnstitute. "Itnhisstudy Opdivo nootnldyemonstratesduperioorveralslurv iv alnodbjectivreesponsreatveersus chemotherapyt,hsetandarodcfareb,utthesbeenefits werseustaineodvetrimeT. hsetudaylssohowed thastquamounson-smalcleluncgancehrauasnique biologtyhartesulteidn similaerfficacaycross levelosPfD-Le1xpression."

Opdivo demonstratecadonsistensttatisticallsyigni ficanstuperioritoyvedrocetaxealcrosasll secondareyndpointisncludinogveralrlesponsreate anpdrogression-freseurvivaRl. esultshowetdhat,

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objectivresponsreat(e20%v)ersudsocetaxe(l8.8%()95%CIP;=0.0083)R. esponsefsor Opdivo were ongoinagntdhme ediadnuratioonrfesponswe ansorteache(drang2e.t92o1+monthsw) itahlteas1t1
monthosffollow-upt;hme ediadnuratioonrfesponsfeodrocetaxewl a8s.m4 onth(srang1e.4+t1o5+
months).
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benefiftor Opdivo acroshsistologieasnedtiologieisnon-smalcleluncgancerT. h iisncredibly encouraginngewasws ceontinutesotudpyotentianlewoptiontshamt aiymprovuepona,npdotentially replaceth, ceurrensttandarodcfare."

About CheckMate -017

CheckMat-e01w7 aPashasIeIIo,pen-label, randomizecdlinicatlriatlhaetvaluated Opdivo 3 mg/kigntravenousloyve6rm0 inut esvertywwo eekvsersusstandarodcfared,ocetaxe7lm5 g/m2 intravenouslaydministereedverw3y eekispnatientws itahdvancesdquamounson-smalclelung
cancewr hhoapdrogressedurinogarfteornperioprlatinumdoublet-basecdhemotherapryegimenT. he study'psrimareyndpoinwt aosveralslurviv alnsdecondareyndpointisncludepdrogression-free survivaalnrdesponsreateT. hter iailncludepdatientrsegardlesostfheiPrD-L(1programmedeath ligand-1e)xpressiosntatus.
Orfandomizepdatientistnhteria(ln=272)8,3%(225h)aqduantifiablPeD-Le1xpressionR. ates oPfD-Lp1ositivitwy erbealancebdetweetnreatmengtroupsA. crospsre-specifieedxpressiolnevels (1%5,%a,n1d0%), Opdivo demonstratesduperiobrenefiatcrosaslelndpointisndependenotPfD-L1
expressionO. veralalnpdrogression-free survivaalmonPgD-Ls1ubgroupfsavored Opdivo anwd as similatrtohperimarpyopulationS.imilaorbjectivreesponsreatews eroebserveidpnatientws ithigh
anldowo,nrPoD-Le1xpressiona,nwd erceonsistentlhyighefror Opdivo versudsocetaxel.
Thseafetpyrofiloef Opdivo iCn heckMat-e01w7 acsonsistent witphriosrtudieasnfdavorable versudsocetaxelT. reatment-relatead verseeventosccurreldesfsrequentlwy ith Opdivo (angyrade,
58%g;rad3e-46,.9%n;gorade5eventst)hadnocetaxe(langyrade8,6%g;rad3e-45,5%g;rad5e,
2.3%)in, cludinbgothematologiacnndon-hematologitcoxicities.

About Non-Small Cell Lung Cancer

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csombinedN. on-smalclelluncganceiorsnoef
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About Opdivo

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iwn hicmh orteha8n,00p0atienthsavbeeeennrollewd orldwide.

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Opdivo fotrhtereatmenotpfatientws ituhnresectabloemr etastatimc elanomandiseasperogression following Yervoy (ipilimumaba)ndiB,f RAFV60m0 utatiopnositiveBa, RAFinhibitorO. Mn arc4h,

2015, Opdivo receiveidtsseconFdDAapprovaflotrhterea tmenotpfatientws itmh etastatiscquamous non-smalclelluncgancewr itphrogression oonarfteprlatinum-basecdhemotherapy.

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PermanentldyiscontinuOe PDIVOfoGr rado3ea4rnwd ithholOd PDIVOuntirlesolutiofnor
Grad2e.

 ITn ria3dl,iarrheoaccurreid2n1%(24/117o)pfatientrseceivinOg PDIVOG. radi3emmune- mediatecdolitiosccurreid0n.9%(1/117o)pfatientsM. onitopratientfsoirmmune-mediated

colitisA. dministecrorticosteroidfsoGr rad(2eof mortehad5naydsura tion)3o,,c4rolitis. WithholOd PDIVOfoGr rado2e3rP.ermanen tldyiscontinuOe PDIVOfoGr radc4eolitiosr recurrenctolitiuspornestartinOg PDIVO.

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(14%)A, LT(12%)a,ntdotabl
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priotraonpderiodicalldyurintgreatmenFt.oGr rado2es3rerumcreatininelevationw, ithhold
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fsoGr rads4eerumcreatinineelevatioan d

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Immuno-Oncology at Bristol-Myers Squibb

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About Bristol-Myers Squibb

Bristol-MyerSsquibibgaslobaplharmaceuticaclompanwy hosme issiointsdoiscoverd,evelop andeliveirnnovativme edicinetshahtelpatients prevaiolvesrerioudsiseasesF.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.

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