Oncology | Phase III Developments | UNITED KINGDOM

AstraZeneca PLC

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Imfinzi Granted FDA Priority Review for Less-Frequent, Fixed-Dose Use

Lead Product(s): Durvalumab,Tremelimumab

Therapeutic Area: Oncology Product Name: Imfinzi

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 August 18, 2020

Details:

AstraZeneca’s Imfinzi received acceptance for its supplemental Biologics License Application and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer and bladder cancer.

Centus Biotherapeutics

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Centus Biotherapeutics Announces Positive CHMP Opinion for FKB238, Biosimilar Bevacizumab

Lead Product(s): Bevacizumab,Carboplatin,Paclitaxel

Therapeutic Area: Oncology Product Name: Equidacent

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 July 27, 2020

Details:

The decision of the European Commission on the approval is expected in September 2020, which would grant Centus the marketing authorization in 27 European Union member states, the United Kingdom and the European Economic Area member states of Norway, Iceland and Liechtenstein.

GlaxoSmithKline

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GSK Announces FDA Advisory Committee Votes in Favour of Positive Benefit/Risk Profile for Belantamab Mafodotin

Lead Product(s): Belantamab mafodotin

Therapeutic Area: Oncology Product Name: GSK2857916

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 July 14, 2020

Details:

Recommendation is based on data from the DREAMM clinical trial programme, including 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.

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.

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AstraZeneca PLC

Imfinzi Granted FDA Priority Review for Less-Frequent, Fixed-Dose Use

Centus Biotherapeutics

Centus Biotherapeutics Announces Positive CHMP Opinion for FKB238, Biosimilar Bevacizumab

GlaxoSmithKline

GSK Announces FDA Advisory Committee Votes in Favour of Positive Benefit/Risk Profile for Belantamab Mafodotin

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