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Head-To-Head Lung Data Support Boehringer’s Gilotrif Over Iressa

 
• By Emily Hayes

Final results from the LUX-Lung 7 trial suggest superior efficacy for Boehringer’s EGFR inhibitor Gilotrif vs. AstraZeneca’s Iressa, albeit with a small absolute improvement in progression-free survival and a higher rate of severe diarrhea.

Final data from a head-to-head trial against AstraZeneca PLC’s EGFR inhibitor in first-line EGFR-positive non-small cell lung cancer give Boehringer Ingelheim GMBH’s first cancer drug Gilotrif (afatinib) a bit of a boost in terms of efficacy, while elucidating differences in severe side effect profiles between the agents.

In the first-line LUX-Lung 7 trial of 319 NSCLC patients, Gilotrif demonstrated a statistically significant 27% improvement in median progression-free survival compared to Iressa. The absolute difference, however, was very...

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More from Clinical Trials

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

More from R&D

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.