Oncology | Phase III Developments | UNITED KINGDOM

AstraZeneca PLC

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Imfinzi confirmed a sustained overall survival benefit in final analysis of the Phase III CASPIAN trial

Lead Product(s): Durvalumab,Tremelimumab,Etoposide

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 March 17, 2020

Details:

High-level results from the final analysis of the Phase III CASPIAN trial showed Imfinzi in combination with a choice of standard-of-care chemotherapies confirmed a sustained overall survival benefit.

AstraZeneca PLC

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Update on Phase III GY004 trial for cediranib added to Lynparza in platinum-sensitive relapsed ovarian cancer

Lead Product(s): Cediranib,Olaparib

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 12, 2020

Details:

The trial did not meet the primary endpoint of progression- free survival vs. platinum-based chemotherapy.

NuCana

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NuCana Receives Positive Opinion for Orphan Drug Designation in the European Union for Acelarin (NUC-1031)

Lead Product(s): Acelarin

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 05, 2020

Details:

Acelarin, in combination with cisplatin, is currently being evaluated in a global Phase III study (NuTide:121) for the first-line treatment of patients with biliary tract cancer.

GlaxoSmithKline plc

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FDA accepts GSK's sNDA for Zejula for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

Lead Product(s): Niraparib

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:

Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib maintenance treatment in the first-line setting.

NuCana

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NuCana Announces First Patients Dosed in Both US and Europe in Phase III Study of Acelarin (NUC-1031) for the First-Line Treatment of Patien...

Lead Product(s): Acelarin,Cisplatin

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 January 27, 2020

Details:

The enrollment of patients in NuTide:121 follows U.S. Food and Drug Administration (FDA) clearance of the company's investigational new drug application (IND) for Acelarin.

GlaxoSmithKline plc

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US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myelo...

Lead Product(s): Belantamab mafodotin

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 January 21, 2020

Details:

The BLA is based on data from the pivotal DREAMM-2 study, which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.