Oncology | Phase III Developments | UNITED KINGDOM

AstraZeneca PLC

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IMFINZI Plus Tremelimumab Demonstrated Promising Clinical Activity and Tolerability in Patients With Advanced Liver Cancer

Lead Product(s): Durvalumab,Tremelimumab

Therapeutic Area: Oncology Product Name: Undisclosed

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 May 29, 2020

Details:

Data presented at ASCO showed patients treated with a single, priming dose of tremelimumab plus IMFINZI achieved longest median survival among regimens tested.

Bluebird bio

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bluebird bio Announces Amended BCMA CAR-T Collaboration Agreement

Lead Product(s): Idecabtagene vicleucel

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Bristol-Myers Squibb

Deal Size: $200.0 million Upfront Cash: Undisclosed

Deal Type: Collaboration May 11, 2020

Details:

Bluebird bio and BMS are redoubling their commitment to ide-cel and optimizing the relationship as they work together to bring this critical treatment to patients in the commercial setting.

Bluebird bio

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Bluebird Bio to Present Updated Results from Pivotal Phase 2 Karmma Study Of Ide-Cel In Relapsed and Refractory Multiple Myeloma

Lead Product(s): Idecabtagene vicleucel

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 08, 2020

Details:

The presentation will include updated efficacy and safety data from pivotal Phase 2 KarMMa study of ide-cel. Ide-cel is a BCMA-directed genetically modified autologous CAR T cell immunotherapy.

NuCana

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NuCana Announces Re-Opening of Global Phase III Study of Acelarin Plus Cisplatin in Patients with Biliary Tract Cancer

Lead Product(s): Acelarin,Cisplatin

Therapeutic Area: Oncology Product Name: Undisclosed

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 05, 2020

Details:

NuTide:121 is a global randomized Phase III study of Acelarin that will enroll up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia.

AstraZeneca PLC

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AstraZeneca's Lynparza shows further promise in prostate cancer study

Lead Product(s): Olaparib

Therapeutic Area: Oncology Product Name: Undisclosed

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 April 24, 2020

Details:

Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival with Lynparza vs enzalutamide or abiraterone.

GlaxoSmithKline

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GSK Presents New Data from the GARNET Study Revealing Potential of Dostarlimab to Treat Recurrent or Advanced Endometrial Cancer

Lead Product(s): Dostarlimab

Therapeutic Area: Oncology Product Name: Undisclosed

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 23, 2020

Details:

Dostarlimab provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient endometrial cancer who progressed on or after a platinum-based regimen.

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 Product Name: Undisclosed

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 Product Name: Undisclosed

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 Product Name: Undisclosed

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

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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 Product Name: Undisclosed

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.

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AstraZeneca PLC

IMFINZI Plus Tremelimumab Demonstrated Promising Clinical Activity and Tolerability in Patients With Advanced Liver Cancer

Bluebird bio

bluebird bio Announces Amended BCMA CAR-T Collaboration Agreement

Bluebird bio

Bluebird Bio to Present Updated Results from Pivotal Phase 2 Karmma Study Of Ide-Cel In Relapsed and Refractory Multiple Myeloma

NuCana

NuCana Announces Re-Opening of Global Phase III Study of Acelarin Plus Cisplatin in Patients with Biliary Tract Cancer

AstraZeneca PLC

AstraZeneca's Lynparza shows further promise in prostate cancer study

GlaxoSmithKline

GSK Presents New Data from the GARNET Study Revealing Potential of Dostarlimab to Treat Recurrent or Advanced Endometrial Cancer

AstraZeneca PLC

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

AstraZeneca PLC

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

NuCana

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

GlaxoSmithKline

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