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Cancer Enterprise Global Pipeline

Daiichi Sankyo Cancer Enterprise Global Pipeline

As of April 25, 2019

These are investigational agents and are not approved by the FDA or any other worldwide regulatory agency as a treatment for any indication. Efficacy and safety have not been established. There is no guarantee that these investigational agents will become commercially available.

Investigational Antibody Drug Conjugate (ADC) Franchise

 

Compound Tumor Type Tumor Expressing Highest Phase of Development Location
[Fam-] Trastuzumab Deruxtecan
(DS-8201)

Breast Cancer (HER2 Low) (vs investigator’s choice)

DESTINY-Breast04

HER2

Phase 3

US, EU, Japan, Asia

[Fam-] Trastuzumab Deruxtecan

Breast Cancer (vs T-DM1)

DESTINY-Breast03

HER2 Phase 3 US, EU, Japan, Asia
[Fam-] Trastuzumab Deruxtecan

Breast Cancer (post T-DM1)

DESTINY-Breast02

HER2

Phase 3

US, EU, Japan, Asia

[Fam-] Trastuzumab Deruxtecan

Breast Cancer (post T-DM1)

DESTINY-Breast01

FDA Breakthrough Therapy Designation

FDA Fast Track Designation

HER2 Phase 2 US, EU, Japan, Asia
[Fam-] Trastuzumab Deruxtecan

Gastric Cancer (post-trastuzumab)


DESTINY-Gastric01

SAKIGAKE Designation

HER2 Phase 2 Japan, Asia
[Fam-] Trastuzumab Deruxtecan Colorectal Cancer HER2 Phase 2 US, EU, Japan
[Fam-] Trastuzumab Deruxtecan Non-Small Cell Lung Cancer HER2 Phase 2 US, EU, Japan
[Fam-] Trastuzumab Deruxtecan [in combination with nivolumab]

Breast Cancer

Bladder Cancer
HER2 Phase 1 US, EU
[Fam-] Trastuzumab Deruxtecan [in combination with pembrolizumab] Breast Cancer, Non-Small Cell Lung Cancer HER2 Phase 1 preparation US, EU
[Fam-] Trastuzumab Deruxtecan [in combination with avelumab] Solid Tumors HER2 Phase 1 preparation US, EU, Asia
[Fam-] Trastuzumab Deruxtecan Solid Tumors HER2 Phase 1 US, Japan
U3-1402

Breast Cancer

HER3

Phase 1

Japan

U3-1402 Non-Small Cell Lung Cancer HER3 Phase 1 US, EU
DS-1062 Non-Small Cell Lung Cancer TROP2 Phase 1 US, Japan
DS-7300

Solid Tumors

B7-H3

Preclinical

--

DS-6157 Gastrointestinal Stromal Tumor (GIST)

GPR20

Preclinical

--

DS-6000 Renal Cancer
Ovarian Cancer

Undisclosed

Preclinical

--

TA-MUC1 Solid Tumor TA-MUC1 Discovery --

 

Investigational Acute Myeloid Leukemia (AML) Franchise

 

Compound Tumor Type Relevant
Pathway
Highest Phase of Development Location
Quizartinib

Relapsed/Refractory AML QuANTUM-R

FDA Priority Review

FDA Breakthrough Designation

FDA Fast Track Designation

Orphan Drug Designation in US, EU and Japan

FLT3 NDA Submission US, EU, Japan

Quizartinib

Newly-Diagnosed AML
QuANTUM-First

FLT3

Phase 3

US, EU, Japan, Asia

Quizartinib + Milademetan

(DS-3032)
Relapsed/Refractory AML
Newly-Diagnosed AML
FLT3
MDM2
Phase 1 US, Japan
Milademetan
(DS-3032)[single agent/combination with azacitabine]

Relapsed/Refractory AML
Newly-Diagnosed AML
 Myelodysplastic Syndrome (MDS)

MDM2

Phase 1

US

Milademetan
 

Solid Tumors, Lymphoma

MDM2

Phase 1

US

Milademetan
 
Solid Tumors, Lymphoma MDM2 Phase 1 Japan
Valemetostat (DS-3201)

AML, ALL

EZH1/2

Phase 1

US

Valemetostat (DS-3201)  AML, Acute Lymphocytic Leukemia (ALL) EZH1/2 Phase 1 US
Valemetostat 

 

Adult T-cell leukemia/lymphoma
Peripheral T-cell lymphoma  (PTCL)

SAKIGAKE Designation for PTCL

EZH1/2

Phase 1

Japan

PLX2853

AML,  Solid Tumors

BRD4

Phase 1

US

DS-1001

AML

IDH1

Preclinical

--

 

Investigational Breakthrough Science Pipeline

 

Compound Tumor Type

Relevant
Pathway

Highest Phase of Development Location

Pexidartinib (PLX3397)

Tenosynovial Giant Cell Tumor (TGCT)* ENLIVEN

FDA Priority Review

 FDA Breakthrough  Therapy Designation

Orphan Drug Designation in US and EU

CSF-1R

NDA Submission

US, EU

DS-1647

Glioblastoma

SAKIGAKE Designation 

Orphan Drug Designation in Japan

Oncolytic HSV-1

Phase 2

Japan

AxiCel (axicabtagene ciloleucel) Large B Cell Lymphoma CD19 CAR-T Phase 2 Japan
DS-1205 (in combination with osimertinib) Non-Small Cell Lung Cancer AXL Phase 1 preparation US
DS-1205 [in combination with gefitinib] Non-Small Cell Lung Cancer AXL Phase 1 preparation Japan
DS-1001 Gliomas IDH1 Phase 1 Japan

*Tenosynovial giant cell tumor (TGCT), which includes pigmented villonodular synovitis (PVNS) and giant cell tumor of the tendon sheath (GCT-TS).

PP-US-ON-0700
05/19

 

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Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking in order to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do.

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