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Payback Time For Lilly? Erbitux Follow-on Succeeds In Squamous Lung Cancer Trial

 
• By Emily Hayes

Lilly’s necitumumab – gained through the company’s ImClone acquisition – demonstrates an overall survival benefit in the SQUIRE study against first-line metastatic squamous NSCLC. Pleasantly surprised by the outcome, some analysts start to expect blockbuster sales.

The unexpected success of Eli Lilly & Co.’s IgG1 antibody necitumumab in the Phase III SQUIRE squamous non-small cell lung cancer trial provides more validation for the company’s $6.5 billion takeover of ImClone Systems Inc. and suggests Bristol-Myers Squibb Co. was too quick in dropping the program earlier this year.

Necitumumab (IMC-11F8) is a monoclonal antibody that blocks EGFR. The candidate is a fully humanized version of the targeted therapy...

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More from Clinical Trials

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from R&D

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.