Bristol's Opdivo Delivers, But CheckMate 227 Uncertainties Cloud Quarter
The use of the emerging tumor mutation burden biomarker and its relevance to the outcome of the CheckMate 227 study of Opdivo/Yervoy in first-line lung cancer was a hot topic during Bristol's Q3 earnings call, but questions remain.
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Overall survival data are now not due until the second half of the year but however they turn out competitor Merck & Co is still expected to dominate the late-stage NSCLC market with Keytruda.
US FDA officials have supported tumor mutation burden as a biomarker, but analysts question whether a subset analysis of CheckMate 227 will be enough to support approval of Bristol's Opdivo/Yervoy combination in first-line lung cancer.
Hemophilia and immuno-oncology will be in the spotlight as earnings season continues into February. Will Bristol be a buyer or an acquisition target? How will Sanofi fare with its new acquisitions? And how will Teva and GSK fare as they face generics for top brands?