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A Biomarker For Bristol: Mutation Burden Shows Promise In Small Cell Lung Cancer

 
• By Emily Hayes

Phase I/II data from Opdivo/Yervoy combination in SCLC provide more evidence that tumor mutation burden is emerging as a biomarker for immunotherapy, but commercial value is unclear and results don't have implications for the all-important CheckMate 227 non-small cell lung cancer trial, analysts say.

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Bristol-Myers Squibb Co.'s latest data for the combination of Opdivo and Yervoy suggest a role for the duo in a new indication for small cell lung cancer (SCLC) and generally give more support to the emerging biomarker of "tumor mutation burden" in guiding immunotherapy treatment.

PD-L1 expression has been the most commonly used biomarker for checkpoint inhibitor immunotherapies to date, but is a flawed measure...

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• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

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