Oncology | Phase III Developments | JAPAN

Takeda Pharmaceutical

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Takeda to Present Data at Upcoming Virtual Scientific Congresses, Underscoring Breadth of Oncology Portfolio and Emerging Pipeline

Lead Product(s): Pevonedistat,Azacitidine

Therapeutic Area: Oncology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 14, 2020

Details:

Takeda will present data from its expanding oncology pipeline and established product portfolio at two upcoming scientific congresses: ASCO and EHA, that includes clinical data on Pevonedistat, ICLUSIG, NINLARO and among others.

Ono Pharmaceutical

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Positive Data in Hand, Ono/Takeda to Seek 1st-Line RCC Nod for Opdivo/Cabometyx Combo

Lead Product(s): Nivolumab,Cabozantinib,Ipilimumab

Therapeutic Area: Oncology

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2020

Details:

Opdivo and cabozantinib combination treatment demonstrated a significant benefit in its primary endpoint of progression-free survival (PFS) at final analysis, compared to sunitinib alone.

SymBio Pharmaceuticals

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Eagle Pharmaceuticals’ Japanese Licensing Partner SymBio Announces Completion of Clinical Trial Enrollment for TREAKISYM

Lead Product(s): Bendamustine

Therapeutic Area: Oncology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2020

Details:

SymBio Pharmaceuticals Limited has completed patient enrollment in a clinical trial for TREAKISYM rapid infusion in Japan. Company plans to submit a New Drug Application for the product.

Takeda Pharmaceutical

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Takeda Provides Update on TOURMALINE-MM2 Phase 3 Trial

Lead Product(s): Ixazomib,Lenalidomide,Dexamethasone

Therapeutic Area: Oncology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 10, 2020

Details:

The addition of ixazomib to lenalidomide and dexamethasone resulted in an improvement in median progression-free survival of 13.5 months; however, it did not meet the statistical significance.

Takeda Pharmaceutical

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Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG

Lead Product(s): Brigatinib

Therapeutic Area: Oncology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2020

Details:

The sNDA is based on results from the Phase 3 ALTA-1L trial, which is evaluating the safety and efficacy of ALUNBRIG in patients with ALK+ locally advanced or metastatic NSCLC.

Chugai Pharmaceutical

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Chugai Files for Additional Indications of Tecentriq and Avastin for the Treatment of Unresectable Hepatocellular Carcinoma

Lead Product(s): Atezolizumab,Bevacizumab

Therapeutic Area: Oncology

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 14, 2020

Details:

The filing is based on the results from the global phase III IMbrave150 study in patients with unresectable HCC who have not received prior systemic therapy