http://www.synix.co.jp

サイニクス株式会社 〒162-0825 東京都新宿区神楽坂 1-2 研究社英語センタービル 3階 Tel:03-6280-8160 Fax:03-6280-8203

N = NEW / 新規掲載のレジメン

R = REMOVED / 本アップデートでレポートから削除されたレジメン

Regimen Change Setting Status Reason for Change

Opdivo + RT +/- cisplatin locally advancedPromoted to

Wild Card

Enrollment complete:

CheckMate-9TM (NCT03349710, Phase 3)

Imfinzi +/- tremelimumab R2nd line,

later metastatic

Failed to meet primary endpoint:

EAGLE (NCT02369874, Phase 3)

primary endpoint - OS

Regimen Change Setting Status Reason for Change

ThermoDox + RFAunresectable,

localized disease

Promoted to

Wild Card

Enrollment complete:

OPTIMA (NCT02112656, Phase 3)*

Licensed to Yakult Honsha in Japan

Lenvima R 1st line Approved**

Regimen Change Setting Status Reason for Change

canakinumab N adjuvant On the HorizonInitiation of pivotal trial:

Canopy-A (NCT03447769, Phase 3)

Imfinzi R consolidation Approved**

Opdivo R consolidation

No progress in development status since RTOG

3505 termination*

(NCT02768558: Another treatment found

efficacious)

Keytruda + Alimta + platinum1st line,

non-squamous

Promoted to

Treatment TrendApproved

Tecentriq + platinum-doublet +/-

Avastin

1st line,

non-squamous

Promoted to

Treatment TrendApproved

Keytruda + carboplatin + taxane1st line,

squamous

Promoted to

Treatment TrendApproved

Tecentriq R relapsed / refractory Approved**

Bavencio PD-L1 +Promoted to

Wild Card

Enrollment complete:

JAVELIN LUNG 100 (NCT02576574, Phase 3)

Tecentriq PD-L1+Promoted to

Wild Card

Enrollment complete:

IMpower110 (NCT02409342, Phase 3)

Keytruda + epacadostat R1st line,

PD-L1 high

Pivotal tial terminated:

ECHO-305/KEYNOTE-654-01

(NCT03322540, Phase 2)

Tagrisso Nconsolidation

after chemoRTOn the Horizon

Initiation of pivotal trial:

LAURA (NCT03521154, Phase 3)

Avastin + Tarceva 1st linePromoted to

Wild Card [+]

Positive results:

JO25567 (JapicCTI-111390, Phase 2)

NEJ026 (UMIN000017069 , Phase 3)

Furuya, J Clin Oncol, 2018

Cyramza + Tarceva 1st linePromoted to

Wild Card

Enrollment complete:

RELAY (part B) (NCT02411448, Phase 3)

Vizimpro 1st linePromoted to

Treatment TrendRegulatory filing

Keytruda + Alimta + platinum N relapsed / refractory On the HorizonInitiation of pivotal trial:

KEYNOTE-789 (NCT03515837, Phase 3)

Alunbrig N ALK inhibitor refratory On the HorizonOngoing Japanese bridging study:

Brigatinib-2001 (NCT03410108, Phase 2)

Tafinlar + Mekinist R relapsed / refractory Approved**

Regimen Change Setting Status Reason for Change

Sutent R Adjuvant, high-risk Dvelopment not being pursued in Japan

ALK+

BRAFmt

Renal Cell Carcinoma (RCC)

EGFRmt

Head & Neck

Hepatocellular Carcinoma (HCC)

Non-Small Cell Lung Cancer (NSCLC)

Wild type

PD-L1

Copyright Synix Inc. 2019 All Rights Reserved.

http://www.synix.co.jp

サイニクス株式会社 〒162-0825 東京都新宿区神楽坂 1-2 研究社英語センタービル 3階 Tel:03-6280-8160 Fax:03-6280-8203

Regimen Change Setting Status Reason for Change

Imfinzi + tremelimumab N limited disease On the HorizonInitiation of pivotal trial:

ADRIATIC (NCT03703297, Phase 3)

Imfinzi + etoposide + platinum +/-

tremelimumab1st line

Promoted to

Wild Card

Enrollment complete:

CASPIAN (NCT03043872 , Phase 3)

Keytruda + etoposide + platinum 1st linePromoted to

Wild Card

Enrollment complete:

KEYNOTE-604 (NCT03066778 , Phase 3)

Tecentriq + etoposide + carboplatin 1st linePromoted to

Wild Card [+]

Positive results:

IMpower133 (NCT02763579 , Phase 3)

Horn et al., NEJM 2018; 379:2220-2229

Opdivo +/- Yervoy R maintenance

Failed to meet primary endpoint:

CheckMate-451 (NCT02538666 , Phase 3)

primary endpoint - OS

Opdivo monotherapy R relapsed / refractory

Failed to meet primary endpoint:

CheckMate-311 (NCT02481830 , Phase3 )

primary endpoint - OS

rovalpituzumab tesirine R relapsed / refractory

Trial halted by Independent Data Monitoring

Committee:

TAHOE (NCT03061812 , Phase3)

OS shorter in rovalpituzumab arm

RT = radiotherapy / 放射線療法

RFA = radiofrequency ablation / ラジオ波焼灼療法

ChemoRT = chemoradiotherapy / 放射線化学療法

OS = Overall Survival / 全生存期間

* trial site does not include Japan / 海外治験

** approved agents are removed from Future Trends and Insights after 6months from approval

　/ 承認より6ヵ月経過したレジメンはFuture Trends and Insightsより削除

On The Horizon, Wild Card, Treatment Trend: 各ステータスの定義はレポート冒頭（INTRODUCTION）をご参照ください

開発中薬剤を見直した結果、本アップデートでは各薬剤の注目度に変更なし

Colorectal (CRC)

Uterus Endometrial

Small Cell Lung Cancer (SCLC)

Limited disease

Extensive disease

Copyright Synix Inc. 2019 All Rights Reserved.