Surprise! It’s A Phase III Failure

When Phase III clinical trial failures happen it is a painful blow – to the drug manufacturer, to investors and to patients. Scrip takes a look at some of the biggest Phase III surprises since 2010.

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When Bristol-Myers Squibb Co. announced Aug. 5 that a key Phase III trial testing the checkpoint inhibitor Opdivo (nivolumab) in first-line lung cancer, CheckMate 026, missed the primary progression-free survival endpoint, the news hit the company like a ton of bricks.

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CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
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CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.

AstraZeneca’s Truqap Trips Up In Prostate Cancer Study

 
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The AKT inhibitor proves ineffective for metastatic castration-resistant disease in a Phase III trial.

Merck Set To Add Perioperative Head-And-Neck Cancer To Keytruda Label

 
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With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.

Pipeline Watch: Five Approvals And One Phase III Readout

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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EU Approves Tremfya In Third Indication, Ulcerative Colitis

 

J&J secures EU approval for its IL-23 inhibitor Tremfya for ulcerative colitis, its third indication in the region, amid strong competition in the sector. EU approval is also awaited for Crohn’s disease.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
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Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Merck Set To Add Perioperative Head-And-Neck Cancer To Keytruda Label

 
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With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.