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Ph 2/3 Study in Subjects With MPM w/Low ASS 1 Expression to Assess ADI-PEG 20 With

Pemetrexed and Cisplatin (ATOMIC)

ClinicalTrials.gov Identifier: NCT02709512

Recruitment Status ƒÊ : Recruiting

First Posted ƒÊ : March 16, 2016

Last Update Posted ƒÊ : December 4, 2017----------------¡´³Ì«á¤@¦¸§ó·s¬O¤W¦¸ªk»¡«e¤@¶g!

Study Type ƒÊ : Interventional (Clinical Trial)

Estimated Enrollment ƒÊ : 386 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Triple (Participant, Care Provider, Investigator)

Primary Purpose: Treatment

Official Title: Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

Study Start Date ƒÊ : October 2016

Estimated Primary Completion Date ƒÊ : April 2018--------¡´¦A¨â­Ó¤ëªì¨B§¹¦¨

Estimated Study Completion Date ƒÊ : June 2018 ----------¡´¦A¥|­Ó¤ë½µP!!!

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EISAI CONTRIBUTES TO TAIWAN EARTHQUAKE RELIEF EFFORTS

We express our deepest sympathy to the victims of the earthquake in Hualien County, eastern Taiwan.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ¡§Eisai¡¨) announced today that its Taiwanese subsidiary Eisai Taiwan Inc. (Location: Taipei) has donated 1 million Taiwan dollars (around 3.7 million yen) via the Hualien social welfare account to aid relief efforts in the disaster-stricken area.

Our thoughts and prayers are with the victims and their families during this difficult time.

Media Inquiries:

Public Relations Department,

Eisai Co., Ltd.

+81-(0)3-3817-5120

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Leo¤j¡A·sÃĨS¦³¨º»òÃøÀ´¡A¥u­nÄ@·Nªá¤@ÂI¤ß«ä´N·|¾Ç¨ì«Ü¦h¡A¤£¬O¨C¤@­ÓÂå®v³£À´·sÃÄ¡A¨ä¹ê¥u¬O¦³¤@ÂI¬ÛÃö©Ê¦Ó¤w¡A¨Ã¤£¬Oµ´¹ï¡I°£¤F¦å¸~¬ìªºÂå®v¡A¤j¦h¼ÆÂå®v¬O¬Ý¤£À´Àù¯g·sÃĬã¨sªº¡I¬Æ¦Ü¡A¦å¸~¬ìÂå®v¤]¥u¬OÀ´¨ä¤¤¤@³¡¤À¦Ó¤w¡IÁ`¤§¡A¬Ý¤[¤F´NÀ´¤F~~

¡´BMSµo©Æ¤FCheckMate-227ªº¦n®ø®§¡AOpdivo+Yervoy vs. ¤ÆÀø¡A¤@½uªvÀø¦³TMB(≥10 mutations/megabase, mut/mb)ªºNSCLC¡AmPFS«Ü¦n¡I

Pivotal Phase 3 CheckMate -227 Study Demonstrates Superior Progression-Free Survival (PFS) with the Opdivo Plus Yervoy Combination Versus Chemotherapy in First-Line Non-Small Cell Lung Cancer (NSCLC) Patients with High Tumor Mutation Burden (TMB)

¡´Tumor Mutation Burden (TMB)---´N¬O¸~½F²Ó­M¬ðÅܪº°ò¦]¼Æ¶q¡A¤]´N¬O±K«×§a¡A¨C¤@¦Ê¸U­Ó¸~½F°ò¦]§Ç¦C¦³¤j©óµ¥©ó10­Ó°ò¦]§Ç¦C¬ðÅÜ¡A´N·|Åܦ¨«Ü©úÅ㪺¸~½F²Ó­M¡A´N·|«Ü®e©ö³Q§K¬Ì¨t²Î¿ëÃÑ¥XÃa¤H¨­¥÷¡A©Ò¥HTMB¶V°ªªºÀø®Ä¤]¶V¦n¡I

¬ã¨s³o­Ó»â°ìªºË³Ë³ªÌ´N¬OFoundation Medicine, FoundationOne CDx³o¨â®a¤½¥q¡ABMS³£¦³¸ò¥L­Ì¦X§@¡C

¡´³o¬O²Ä¤@½g¤£¦Ò¼{PD-L1 expression, phase 3µû¦ôI-O+I-O¦b¤@½uªvÀø¦³TMBªºNSCLC¤Wªº¼Æ¾Ú¡A

First and only Phase 3 trial to evaluate and show a highly statistically significant PFS benefit with an I-O/I-O combination in first-line NSCLC patients with high TMB, regardless of PD-L1 expression

¡´µ²ªGÀ³¸Ó´Nµ¥ASCO§a~~¤]·|¦A¤½§iPD-L1 expressionªºmOS

Results will be shared with regulatory authorities and presented at a future congress

Trial will continue as planned to assess the Opdivo plus Yervoy combination for the other co-primary endpoint of overall survival in patients whose tumors express PD-L1

¡´CheckMate-227«ÜÆgªº³]­p¡A¦³

¦³PD-L1 expressionªº¡÷ Opdivo+yervoy vs. ¤ÆÀø¡BOpdivo vs. ¤ÆÀø

¨S¦³PD-L1 expressionªº¡÷Opdivo+yervoy vs. ¤ÆÀø¡BOpdivo+¤ÆÀø vs. ¤ÆÀø

CheckMate -227 is an open-label Phase 3 trial with more than 2,500 patients randomized across non-squamous and squamous histologies, evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer (NSCLC). This large program is comprised of three parts ¡V Parts 1a and 1b and Part 2.

Part 1a is evaluating Opdivo plus Yervoy and Opdivo monotherapy versus chemotherapy in patients whose tumors express PD-L1. Part 1b evaluated Opdivo plus Yervoy and Opdivo plus chemotherapy versus chemotherapy in patients whose tumors do not express PD-L1. PD-L1 expression levels were assessed using the Dako-developed diagnostic PD-L1 IHC 28-8 pharmDx.

Today¡¦s announcement is based on an analysis of patients from the Opdivo plus Yervoy arms and chemotherapy arms across all of Part 1. There are two co-primary endpoints in Part 1 for the Opdivo plus Yervoy combination: overall survival (OS) in patients whose tumors express PD-L1 (assessed in patients enrolled in Part 1a) and progression-free survival (PFS) in patients with high tumor mutation burden (TMB), regardless of PD-L1 expression (assessed in patients enrolled across Parts 1a and 1b).

¡´±Nªñ45%ªºTMB¯f¤H¡A°ò¦]§Ç¦C³£¦³≥10­Ó¬ðÅÜ (mutations/megabase)

Approximately 45% of the TMB-evaluable patients had tumors that expressed high (≥10 mut/mb) TMB in the study. BMS has an ongoing collaboration with Foundation Medicine and will continue the partnership to seek regulatory approval for the FoundationOne CDx as a companion diagnostic to assess TMB for the potential indication of Opdivo plus Yervoy in first-line NSCLC.

Part 2 is evaluating Opdivo plus chemotherapy versus chemotherapy in a broad population with a primary endpoint of OS.

Opdivo and Yervoy are dosed as follows in the study: Opdivo 3 mg/kg every two weeks with low-dose Yervoy (1 mg/kg) every six weeks.

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¡´¤d¸U¤£­n´Á«Ý¦b³o¸Ì·|¦³©úµP¡´-----------for everyone.

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Go go Polaris!

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2018/01/18 ASCO MPM (ªÍ¶¡¥ÖÀù)guideline(ªvÀø·Ç«h)®¨®¨¦a½Ï¥Í¤F¡A¦Ñ´­¬Û«H¥xÆW§ë¸ê¤H¨S¦³¥ô¦ó¤@­Ó¤Hª`·N¨ì¡I¤µÂ^¨ú¨ä¤¤ªººëµØ¤À¨É¡A¤§«á¦A¾ã²z¦¬¿ý¡I

Treatment of Malignant Pleural Mesothelioma: American Society of Clinical Oncology Clinical Practice Guideline

Hedy L. Kindler, Nofisat Ismaila, Samuel G. Armato III, Raphael Bueno, Mary Hesdorffer, Thierry Jahan,Clyde Michael Jones, Markku Miettinen, Harvey Pass, Andreas Rimner, Valerie Rusch, Daniel Sterman,Anish Thomas, and Raffit Hassan

Published at jco.org on January 18, 2018.

KEY RECOMMENDATIONS

¡´Chemotherapy

Recommendation 1.1: Chemotherapy should be offered to patients with mesothelioma because it improves survival and quality

of life (Type of recommendation: evidence based; Evidence quality: intermediate; Strength of recommendation: strong).

¡´MPMªº¯f¤H¡AÀ³´£¨Ñ¤ÆÀø¡A¦]¬°¥i¥H«P¶i¥Í¦s²v¤Î¼W¶i¥Í¬¡«~½è¡C

The SWAMP (South West Area Mesothelioma and Pemetrexed) trial µû¦ô¥Í¬¡«~½è

58¦ì¤@½upemetrexed/platin¤ÆÀø vs. 15 best supportive care (BSC)

¤ÆÀøªº¥Í¬¡«~½è¤ñBSC¦n (P = .006);

Recommendation 1.2: In asymptomatic patients with epithelial histology and minimal pleural disease who are not surgical candidates, a trial of close observation may be offered prior to the initiation of chemotherapy (Type of recommendation: informal

consensus; Strength of recommendation: moderate).

¡´¨S¦³¯gª¬¡Bepithelial type MPM¤Î¶È¦³»´·L¯Ý½¤¯e¯f¦ý¤£¾A¦X±µ¨ü¤â³Nªº¯f¤H¡A±µ¨ü¤ÆÀø«e¡A¥i¥H¥ý´£¨Ñ¦³±K¤ÁÆ[¹îªºÁ{§É¬ã¨s¡C

Recommendation 1.3: Selected patients with a poor performance status (PS 2) may be offered single-agent chemotherapy or palliative care alone. Patients with a PS of 3 or greater should receive palliative care (Type of recommendation: evidence based; Evidence quality: low; Strength of recommendation: moderate).

¡´ECOG 2ªºMPM¯f¤H¡A¥i¥H´£¨Ñ³æ¤@¤ÆÀø©Îpalliative care(¦w¹ç½w©M¯gª¬ªvÀø)¡CECOG¤j©óµ¥©ó3ªºMPM¯f¤H¡A´N±µ¨üpalliative care(¦w¹ç½w©M¯gª¬ªvÀø)´N¦n¤F¡C

The MS01 phase III trial

active symptom control (ASC) vs. mitomycin/vinblastine/cisplatin or vinorelbine

n= 409 previously untreated MPM-----¤@½uªvÀø

mOS= 7.6 months vs. 8.5 months (HR, 0.89;P = 0.29)----¤£¹F¼Ð¡I

Recommendation 2.1: The recommended first-line chemotherapy for patients with mesothelioma is pemetrexed plus platinum. However, patients should also be offered the option of enrolling in a clinical trial (Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: strong)

¡´¤@½u¤ÆÀø«Øij¥ÎÃĬ°pem+cis. ¦ý¬OÀ³¸Ó«Øij¯f¤H¥[¤JÁ{§É¬ã¨s¡I

single-blind, RCT phase 3

cisplatin (75 mg/m2) + pemetrexed (500 mg/m2) vs. cisplatin

n=456 previously untreated patients with MPM---¡´ª`·N¬Oepithelial type©~¦hªº¤@½uªvÀø

mOS= 12.1 vs. 9.3 months (P = .020;HR, 0.77) ----¹F¼Ð¡I

MPFS= 5.7 vs. 3.7months; P = .001----¹F¼Ð¡I

ORR= 41.3% vs. 16.7%; P , .001----¹F¼Ð¡I

A phase III trial

antifolate raltitrexed (80 mg/m2)+cisplatin (80 mg/m2) vs. cisplatin n=250---¡´ª`·N¬Oepithelial type©~¦hªº¤@½uªvÀø

ORR= 23.6% vs. 13.6%

mOS=11.4 vs. 8.8 months

1-year survival= (46% v 40%)

Recommendation 3.1: The addition of bevacizumab to pemetrexed-based chemotherapy improves survival in select patients and therefore may be offered to patients with no contraindications to bevacizumab. The randomized clinical trial demonstrating benefit with bevacizumab used cisplatin/pemetrexed; data with carboplatin/pemetrexed plus bevacizumab are insufficient for a clear

recommendation (Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: moderate)

¡´¦pªG¹ïavastin¨S¦³¸T§Ò¯g¡AÀ³¸Ó«Øij¯f¤H¥Îavastin+pem+cis.

MAPS study, an open-label RCT phase 3

n= 448; avastin+pem+cis (223) vs. pem+cis (225)

mOS= 18.8 vs. 16.1 months; P = .0167; HR, 0.77.

The superior overall survival in the control arm (which was 12.1 months in the Vogelzang et al trial) was attributed in part to the rigorous eligibility criteria for bevacizumab treatment.

¡´§@ªÌ¦³±j½Õ

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2018/01/18

EMA®Ö­ã¤FAmgen©MAllergan(¨â®a³£¬O¥@¬É«e20¤jÃÄ°Ó)¦@¦P¶}µoªºMVASI(Avastinªº¥Íª«¬Û¦üÃÄ)

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~ªÑ¥«½Ð½×ªÑ«~¡A­Y«D¡uªF¨¸¡v¦Ñ´­ªº¯f¤H¤Å½ÍÂå¼w¡A»{ÃÑ¡uªF¨¸¡v¦Ñ´­¬O½Öªº¤H«Ü¦h¡A¥[­«½ÚÁ½¸o°l·¹´Á¤»­Ó¤ë~

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³o¤@¨â¤Ñ¤j®aÀ³¸Ó³£¥u¬Ý¨ìCelgene¨ÖJuno¡A«o©¿²¤¤F2018/01/19 Celgene¦bASCO GI Symposium¤½§G

ABRAXANE + Gemcitabine¤@½uªvÀø¥Î©óLocally Advanced Pancreatic Cancerªº¼Æ¾Ú¡I

Investigational Data Presented at ASCO GI Evaluate ABRAXANE Regimen for Patients

with Locally Advanced Pancreatic Cancer

ABRAXANE= paclitaxel protein-bound particles for injectable suspension(albumin-bound)

newly diagnosed, locally advanced pancreatic cancer·s¶EÂ_§½³¡«I¥Çªº¯f¤H(©|¥¼»·ºÝÂಾ)

6 cycles of ABRAXANE + gem induction therapy (n=106)

median time to treatment failure (mTTF)= 8.8 months (90% CI: 6.67-9.82),

77.6% DCR ≥ 16 wks (DCR ≥ 16 wks: SD≥ 16 wks = 44.9%, CR = 0%, PR = 32%

65.4% DCR ≥ 24 wks (DCR ≥ 24 wks: SD≥ 24 wks = 32.7%, CR = 0%, PR = 32%).

The ORR was 32% (CR=0%, PR=32%),

mPFS= 10.8 months (9,26-11.63; 90% CI)

12-month estimated OS= 72% (64.5% - 78.9%; 90% CI).

The most common Grade ≥ 3 adverse events (AE)(≥10%) were neutropenia (42%), anemia (11%), and fatigue (10%).

¡´ª`·N¡I¥H¤W³£¬O90%CI¡A©M95%CIªº«H«×®t«Ü¦h¡I¡I¡I

ÁÙ°O±oADI+Gem+nab-pacªº¯ØŦÀù¼Æ¾Ú¶Ü¡H

A phase 1/1B trial of ADI-PEG 20 plus nab-paclitaxel and gemcitabine in patients with

advanced pancreatic adenocarcinoma

DOI: 10.1002/cncr.30897, Accepted: June 12, 2017

¯f¤H=18¦ìmetastatic pancreatic cancer, ECOG 0,1

´¿¸g±µ¨ü¹L1¦¸¨ä¥LªvÀøªº(dose-escalation cohort);

no prior treatment (expansion cohort)---¦ý¬O¦pªG·íªìªº¤ÆÀø¬O»²§U©Êªº¥BÀøµ{µ²§ô¶W¹L6­Ó¤ëªº¥i¥H¯Ç¤J

¨C¥|¶g¤@­ÓÀøµ{

gemcitabine (1000 mg/m2); nab-paclitaxel (125 mg/m2)--¨C¶g1¦¸¡A¨C¥|¶g¦@3¦¸

IM ADI-PEG 20 18 mg/m2 weekly (cohort 1, n=3)

IM ADI-PEG 20 36 mg/m2 weekly (cohort 2, n=6; expansion cohort, n=9)

primary endpoint= ¨M©wMTD(maximum tolerated dose) and RP2D (recommended phase 2 dose)

¬ã¨s´Á¶¡=November 2014~and September 2015

¸ê®Æ¤ÀªR®É¶¡=January 16, 2017-------¦¹®É³ºµMÁÙ¦³¤@¦ì¯f¤H¦b¥ÎADI-PEG 20(¦Ü¤Ö16¤ë~26­Ó¤ëÁÙ¬¡ªº¦n¦nªº)

3­Ó¯f¤H¦bcohort 1®É¨S¦³DLT(dose-limiting toxicities)µo¥Í¡A©Ò¥Hcohort 2ÅÜ6­Ó,¦³1/6 DLT

©Ò¥H«á¨Ó¨M©wMTD¬°36 mg/m2 weekly¡A¦A¦¬9­Ó¯f¤H(expansion phase)

°Æ§@¥Î= 18¦ì³£¦³grade 3/4; ³Ì±`µo¥Íªº¬°

neutropenia (12¦ì67%), leukopenia (10¦ì56%), anemia (8¦ì44%),lymphopenia (6¦ì33%)

¨S¦³µLªk­@¨üªº°Æ§@¥Îµo¥Í¡A¥B67%¥H¤Wªº°Æ§@¥Î³£¬Ogem+nab-pacªº°ÝÃD

PR=7/18(39%),SD=10/18(56%),NE=1/18,DCR=17/18(94.4%)

¥ÎRP2D(36 mg/m2 weekly)ªvÀøªº11¦ì¤¤---½×¤å¸Ì¦³«Üº}«Gªº¹Ï

PR=5/11(45.5%)--------(ÁY¤p80%ªº¦³¨â¦ì,¨ä¥Lªº³£¦³50%~55%ªºÁY¤p)(«ùÄòªº®É¶¡¦³24wks,32wks,48wks,80wks,¤@ª½«ùÄòªº)

SD=5/11(45.5%)--------(¤]³£¦³10%~25%ªºÁY¤p)

DCR=10/11(91%)

¡´ORR=45.5% ---------

mPFS= 6.1 months (95% CI, 5.3-11.2months)

mOS= 11.3 months (95% CI, 6.7 months to not reached)----gem+nab-pac=8.5months

¤j®a¤ñ¤@¤ñ

¡´¡´gem+nab-pac¡´Âù¤ÆÀø¥ÎÃĥΦbmetastatic pancreatic cancerªºORR= 23%--RECIST 1.1

¡´¡´ABRAXANE (albumin-bound pac) + Gemcitabine¥Î¦b·s¶EÂ_§½³¡«I¥Çªº¯ØŦÀù¯f¤H(©|¥¼»·ºÝÂಾ)ORR= 32% (RECIST 1.1), DCR=65.4%

¡´¡´ADI+Gem+nab-pac¥Î¦bmetastatic pancreatic cancerªºORR= 39%, DCR= 94.4%

¡´¡´ADI+Gem+nab-pac¥Î(«Øij¾¯¶q36 mg/m2 weekly)¦bmetastatic pancreatic cancerªºORR= 45.5%, DCR= 91%

¦A¦^·Q¤@¤U2017/12/11ªk»¡¡A§d§B»¡¤°»ò¨ÓµÛ¡H

¯ØŦÀùª½±µ¸õ¨ì

¡´ADI+Gem+nab-pac+Immunotherapy¡÷¥ý°µphase 1¬r©Ê´ú¸Õ(n=20)

PI=±N¥ÑMemorial Sloan Kettering ªºDr. Eileen O¡¦Reily¥D«ù¡A¥¿¦b»P¤jÃļt¬¢½Í¤¤¡I

½Í¤°»ò¡H

¬°¤°»òADI+Gem+nab-pacªº¼Æ¾Ú¤w¸g«D±`¦n¤F¡A«o­n»°§Ö§G§½ADI+Gem+nab-pac+Immunotherapy¡H

³æ¯Â¥u¬O·Q­n»»»»»â¥ý¶Ü¡HÁÙ¬O¦³¤°»ò¬ù©w¡H

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~~¦Ñ´­¤~¥ð®§¤F´X¤Ñ,¤@¦¬°²´N¦³¨Æ°µ,¯u¬O¤Ó¥©¤F¡IÁÙ¯uÅÜ©R¹B¦@¦PÅé¤F~~

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¡´Keytruda¨xÀù¤G½u¥ÎÃĪºKeynote 224

KEYNOTE-224: Pembrolizumab in patients with advanced hepatocellular carcinoma previously

treated with sorafenib.

¡´4¤Ñ«e¦b2018 ASCO GI Symposium¤½¶}¼Æ¾Ú

Presented Friday, January 19, 2018

¡´Keytruda¤G½u¥ÎÃĪºKeynote 224

KEYNOTE-224 (NCT02702414), an open label, phase 2 trial assessed the efficacy and

safety of pembrolizumab in pts with advanced HCC previously treated with sorafenib.

¡´¤èªk

Methods:

-age ≥18 y, Child Pugh A, ECOG PS 0-1 and predicted life expectancy > 3 mo.

Keytruda 200 mg Q3W for 2 y or until disease progression,

Response was assessed every 9 wk (RECIST v1.1, central review)

Primary endpoint was ORR (RECIST v1.1, central review).

Secondary endpoints included DOR, DCR, PFS, OS, and safety and tolerability.

Data cutoff date was Aug 24, 2017.

¡´µ²ªG

Results:

-104¦ì¯f¤H, 23¦ìÁÙ¦b«ùÄòªvÀø¤¤(2017/08/24~2018/01/19)(median follow up 8.4 mo, range 0.4-13.6).

-Median age= 68y (range 43-87), 21.2% were HBV+, 26% were HCV+, 94.2% were Child Pugh A,

79.8% had PD on sorafenib and 63.5% had extrahepatic disease.

¡´ORR= 16.3% (95% CI, 9.8 to 24.9);Median time to response(mTTP)=2.1 mo (range 1.8-4.8)

94%¦³¤ÏÀ³ªº¯f¤H¨ä¤ÏÀ³³£≥6 mo.

¤ÏÀ³ªÌ¡÷ CR=1(1.0%), PR=16 (15.4%), SD=47 (45.2%) and PD= 34 (32.7%); DCR=61.5%.

¡´mPFS= 4.8 mo (95% CI, 3.4 to 6.6)

¡´mOS= (9.4 to NA)

¡´The 6 mo PFS=43.1% and OS=77.9%, respectively.

Treatment related (TR) AE= 73.1% of pts;

fatigue (21.2%) and increased aspartate aminotransferase (12.5%) were seen in ≥10% of pts and grades 3-5 TRAE in

25% including 1 death (ulcerative esophagitis).

No cases of HBV/HCV flare occurred; immune mediated hepatitis occurred in 3 (2.9%) pts.

¡´µ²½×

Conclusion:

Pembrolizumab treatment resulted in durable responses and favorable PFS and OS in

pts with advanced HCC previously treated with sorafenib. Safety was generally

comparable to that established for pembrolizumab monotherapy.

Clinical trial information: NCT02702414

¡´¡´¡´¦Ñ´­µû½×

Keytruda HCC¤G½uªvÀø ORR=16.3%(RECIST 1.1)--------¤ñBMS±ß´X­Ó¤ë¡A¬Û«H«Ü§Ö´N·|®³¨ì¤G½uÃÄÃÒ

Opdivo HCC¤G½uªvÀø ORR=14.3%(RECIST 1.1)----------2017/09/22 FDA¤G½uÃÄÃÒ

Regorafenib (Stivarga)--Bayer--(ORR=11% mRECIST; ORR=7% RECIST)----2017/04 FDA¤G½uÃÄÃÒ

Lenvatinib(Lenvima)---Eisai¤é¥»---·Q­n¨ú¥NNexavar¤@½u¥ÎÃĦa¦ìªº¶i«×¡´

Lenvatinib(Lenvima)---Eisai¤é¥»---¥Ø«e¤w¡u»¼¥X¥Ó½Ð¡vHCCÃÄÃÒªº¶i«×

1. Japan (June 2017)

2. United States and Europe (July 2017)

3. China (October 2017)--- 2017/12/27CFDA¥ýµ¹¤F Priority Review and Approval¡Aªñ´Á¥i¥H±K¤Á°lÂÜ¡ACFDA¤°»ò®É­Ô·|µ¹ÃÄÃÒ¡I

4. Taiwan (December 2017).

¡´Eisai RECIST 1.1ªºORR¤w¤½§i¬° ¡´ORR=18.8¡´

EISAI PRESENTS RESULTS OF ANALYSIS OF PHASE III TRIAL OF LENVIMA® (LENVATINIB)

IN HEPATOCELLULAR CARCINOMA BASED ON INDEPENDENT IMAGING REVIEW AT ASCO-GI

¡´¥Ø«e¥_·¥¬PADI+Folfox HCC¤T½u¥ÎÃÄ

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Merck¡¦s KEYTRUDA(R) (pembrolizumab) Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment in Combination with Pemetrexed and Platinum Chemotherapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (KEYNOTE-189)

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA® (pembrolizumab), Merck¡¦s anti-PD-1 therapy, in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee, treatment with KEYTRUDA in combination with pemetrexed plus platinum chemotherapy resulted in significantly longer OS and PFS than pemetrexed plus platinum chemotherapy alone. The safety profile of KEYTRUDA in this combination was consistent with that previously observed.

Results from KEYNOTE-189 will be presented at an upcoming medical meeting and submitted to regulatory authorities.

¡§KEYNOTE-189 showed significant improvement in overall survival and progression-free survival for patients receiving KEYTRUDA in the first-line setting in combination with traditional chemotherapy, compared with those receiving chemotherapy alone,¡¨ said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. ¡§We are deeply grateful to the KEYNOTE-189 patients and investigators for their important contributions to this landmark study, and we look forward to presenting the data in the near future.¡¨

About KEYNOTE-189

KEYNOTE-189 is a randomized, double blind, placebo controlled, Phase 3 study (ClinicalTrials.gov, NCT02578680) investigating KEYTRUDA (pembrolizumab) in combination with pemetrexed and cisplatin or carboplatin compared with pemetrexed and cisplatin or carboplatin alone in patients with advanced or metastatic nonsquamous non-small cell lung cancer, regardless of PD-L1 expression. Patients had no EGFR or ALK genomic tumor aberrations, and had not previously received systemic therapy for advanced disease. The KEYNOTE-189 study was done in collaboration with Eli Lilly and Company, the makers of pemetrexed. The dual primary endpoints are OS and PFS; secondary endpoints include overall response rate (ORR) and duration of response (DOR). The study enrolled 614 patients randomized 2:1 to receive either KEYTRUDA (200 mg fixed dose every three weeks) plus pemetrexed (500 mg/m2 ) (with vitamin supplementation) plus cisplatin (75 mg/m2) or carboplatin AUC 5 on day 1 every 3 weeks (Q3W) for 4 cycles followed by KEYTRUDA 200 mg plus pemetrexed (500 mg/m2 ) Q3W or KEYTRUDA placebo 200 mg plus pemetrexed (500 mg/m2) (with vitamin supplementation) plus cisplatin (75 mg/m2) or carboplatin AUC 5 on day 1 every 3 weeks (Q3W) for 4 cycles followed by KEYTRUDA placebo 200 mg plus pemetrexed (500 mg/m2) Q3W until disease progression, unacceptable toxicity, physician decision or cons

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