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Phase 3 Oncology Compounds main Article

Phase 3 Oncology Compounds

Daiichi Sankyo currently has three compounds in phase 3 clinical development with unique mechanisms of action each focusing on rare or orphan indications such as acute myeloid leukemia (AML), hepatocellular carcinoma (HCC), and tenosynovial giant cell tumor (TGCT).
 
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.

Phase 3 Oncology Compounds-Timeline

Quizartinib

FLT3-ITD Inhibitor

Quizartinib is an investigational oral selective inhibitor of FLT3-ITD inhibitor currently in phase 3 development for newly-diagnosed and relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). It has been granted Orphan Drug Designation and Fast Track Status by the FDA for the treatment of AML.

Two phase 3 studies are currently underway:
 
 QuANTUM-First:  This study is evaluating quizartinib in combination with induction and consolidation chemotherapy as well as a maintenance therapy for newly-diagnosed patients with FLT3-ITD+ AML. For more information about the QuANTUM-First study,  click here  or visit https://clinicaltrials.gov/ct2/show/NCT02668653
QuANTUM-R: This pivotal phase 3 study is evaluating quizartinib versus salvage chemotherapy in patients with refractory or relapsed FLT3-ITD+ AML.  For more information about the QUANTUM-R study,click here or visit www.quantumrstudy.com or https://clinicaltrials.gov/ct2/show/NCT02039726

 

Pexidartinib

CSF-1R Inhibitor

Pexidartinib (formerly known as PLX3397) is an investigational oral selective inhibitor of CSF-1R in Phase 3 development for tenosynovial giant cell tumor (TGCT), also known as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), a rare, usually non-cancerous tumor that affects the synovium-lined joints, bursae, and tendon sheaths. It has been granted Orphan Drug Designation and Breakthrough Therapy Designation by the FDA for the treatment of TGCT.

For more information about the ENLIVEN Phase 3 study, please click here or visit www.ENLIVENtrial.com or https://clinicaltrials.gov/ct2/show/NCT02371369

 

Tivantinib

MET Inhibitor

Tivantinib is an investigational oral MET inhibitor currently in phase 3 development for the second-line treatment of hepatocellular carcinoma (HCC), the most common type of primary liver cancer. It is being developed in partnership with ArQule Inc. in the US and EU. Tivantinib has been granted Orphan Drug Designation by the FDA for the treatment of HCC.

For more information about the METIV-HCC (MET-high patients receiving tivantinib in advanced HCC) study, click here or visit:
https://clinicaltrials.gov/ct2/show/NCT01755767 or www.METIV-HCC.com

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