1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Tumor Mutation Burden Biomarker Emerges In Bristol's '026 Lung Cancer Post Mortem

 
• By Emily Hayes

Bristol says it's too early to make predictions for future immunotherapy regimens based on new tumor mutation burden analysis of the failed Opdivo Checkmate 026 trial aired at the AACR meeting, but the company plans to fully explore this important biomarker.

Tumor mutation burden had a striking correlation with response in an exploratory analysis of Bristol-Myers Squibb Co.'s failed CheckMate 026 study of the PD-1 inhibitor Opdivo in first-line lung cancer, and could be an important biomarker for immunotherapy across tumor types going forward.

An analysis of tumor mutation burden (TMB) was presented by the University of Lausanne's Solange Peters at the American Association for Cancer

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from R&D

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.