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Third-Generation EGFR Inhibitors’ Safety Profiles Under Scrutiny At ASCO

 
• By Emily Hayes and Mary Jo Laffler

In stark contrast with the first generation of EGFR inhibitors, Clovis’ CO-1386 has rash rates that are on par with placebo. But the drug must contend with high rates of excess blood sugar as well as QTc prolongation. AstraZeneca’s AZD9291 has its own safety issues, but coming efficacy results should carry the class.

CHICAGO – The early data on the next generation of epidermal growth factor receptor inhibitors, including drugs from Clovis Oncology Inc., AstraZeneca PLC and Hanmi Pharmaceutical Co. Ltd., suggest significant advances in safety and efficacy over their predecessors in lung cancer, but individual side effect profiles could help differentiate the newcomers.

Results from studies of early stage studies in relapsed/refractory EGFR+ non-small cell lung cancer patients of Clovis’ CO-1686, AstraZeneca’s AZD...

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More from Clinical Trials

New Advisory Group To Shape UK’s Simplified Informed Consent Process

 
• By Anabel Costa-Ferreira

Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

More from R&D

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

Plans For EU Biotech Act Shift Up A Gear

 
• By Eliza Slawther

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.