Oncology | Phase II Developments | JAPAN

Solasia Pharma KK

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Solasia Announces Positive Results of DARINAPARSIN in Pivotal Phase 2 Study for Peripheral T-Cell Lymphoma

Lead Product(s): Darinaparsin

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2020

Details:

The primary endpoint (antitumor effect) was achieved. No new safety concerns were identified in the safety analysis. This study was conducted as the final registration trial for the indication of relapsed or refractory PTCL. Solasia begins preparing for the NDA Filing.

Daiichi Sankyo Co Ltd

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Daiichi Sankyo's ENHERTU® Granted Orphan Drug Designation in the U.S. for Gastric Cancer

Lead Product(s): Trastuzumab deruxtecan

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

Designation follows recent U.S. Breakthrough Therapy Designations for ENHERTU for HER2 positive metastatic gastric cancer and HER2 mutant metastatic non-small cell lung cancer.

Daiichi Sankyo Co Ltd

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Daiichi Sankyo to Present New Research Data Across DXd ADC Portfolio at 2020 ASCO Annual Meeting

Lead Product(s): Trastuzumab Deruxtecan

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 13, 2020

Details:

Research data from the pivotal phase 2 DESTINY-Gastric01 trial of ENHERTU® to be presented along with phase 2 DESTINY-Lung01 and DESTINY-CRC01 research data.

Eisai

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Eisai to Present Latest Data from Oncology Pipeline at ASCO 2020, including KEYTRUDA + LENVIMA Investigational Combination Therapy & HALAVEN

Lead Product(s): Lenvatinib,Pembrolizumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 13, 2020

Details:

Data highlighted shows continued progress on clinical trials for the KEYTRUDA plus LENVIMA combination across multiple tumor types, including a virtual oral presentation on the Phase 2 results of the metastatic clear cell renal cell carcinoma cohort of a Phase 1b/2 study.

Daiichi Sankyo Co Ltd

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Daiichi Sankyo Submits SNDA for Trastuzumab Deruxtecan in Japan for Treatment of Patients with HER2+ Gastric Cancer

Lead Product(s): Trastuzumab Deruxtecan

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

sNDA based on data from the pivotal phase 2 DESTINY-Gastric01 trial and phase 1 trial where trastuzumab deruxtecan showed a significant and clinically meaningful improvement in HER2+ Gastric Cancer.

Daiichi Sankyo Co Ltd

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Daiichi Sankyo Submits Application for CAR T Therapy Axicabtagene Ciloleucel for Treatment of Relapsed/Refractory B-cell Lymphomas

Lead Product(s): Axicabtagene Ciloleucel

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2020

Details:

NDA submission based on previous pivotal trial data and a phase 2 study in Japan in patients with certain relapsed/refractory B-cell lymphomas.

Eisai

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Eisai Announces Latest Data for LENVIMA® in Combination with Everolimus for Advanced Non-Clear Cell Renal Cell Carcinoma

Lead Product(s): Lenvatinib,Everolimus

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 15, 2020

Details:

The single-arm, multicenter, Phase 2 study of lenvatinib in combination with everolimus enrolled 31 patients with unresectable advanced or metastatic nccRCC.

Chugai Pharmaceutical

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Polatuzumab Vedotin Achieved Primary Endpoint in the Japanese study for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Lead Product(s): Polatuzumab Vedotin,Bendamustine,Rituximab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 13, 2020

Details:

Polatuzumab vedotin in combination with bendamustine and rituximab achieved complete response rate in patients with relapsed or refractory diffuse large B-cell lymphoma.

Daiichi Sankyo Co Ltd

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Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint

Lead Product(s): Trastuzumab Deruxtecan

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 27, 2020

Details:

Trial met primary endpoint of objective response rate and key secondary endpoint of overall survival in patients with previously treated HER2 positive metastatic gastric cancer.

Chugai Pharmaceutical

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Verastem Oncology Announces Global Licensing Agreement with Chugai Pharmaceutical Co., Ltd. to Develop and Commercialize RAF/MEK Inhibitor C...

Lead Product(s): VS-6766,Defactinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Verastem Oncology

Deal Size: Undisclosed Upfront Cash: $3.0 million

Deal Type: Licensing Agreement January 08, 2020

Details:

Under the terms of the agreement, Verastem Oncology is responsible for the development and worldwide commercialization of CH5126766.

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Solasia Pharma KK

Solasia Announces Positive Results of DARINAPARSIN in Pivotal Phase 2 Study for Peripheral T-Cell Lymphoma

Daiichi Sankyo Co Ltd

Daiichi Sankyo's ENHERTU® Granted Orphan Drug Designation in the U.S. for Gastric Cancer

Daiichi Sankyo Co Ltd

Daiichi Sankyo to Present New Research Data Across DXd ADC Portfolio at 2020 ASCO Annual Meeting

Eisai

Eisai to Present Latest Data from Oncology Pipeline at ASCO 2020, including KEYTRUDA + LENVIMA Investigational Combination Therapy & HALAVEN

Daiichi Sankyo Co Ltd

Daiichi Sankyo Submits SNDA for Trastuzumab Deruxtecan in Japan for Treatment of Patients with HER2+ Gastric Cancer

Daiichi Sankyo Co Ltd

Daiichi Sankyo Submits Application for CAR T Therapy Axicabtagene Ciloleucel for Treatment of Relapsed/Refractory B-cell Lymphomas

Eisai

Eisai Announces Latest Data for LENVIMA® in Combination with Everolimus for Advanced Non-Clear Cell Renal Cell Carcinoma

Chugai Pharmaceutical

Polatuzumab Vedotin Achieved Primary Endpoint in the Japanese study for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Daiichi Sankyo Co Ltd

Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint

Chugai Pharmaceutical

Verastem Oncology Announces Global Licensing Agreement with Chugai Pharmaceutical Co., Ltd. to Develop and Commercialize RAF/MEK Inhibitor C...