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Bristol-Myers Squibb reported positive results Monday in a crucial immunotherapy trial, using a combination of the two drugs Opdivo and Yervoy to treat patients with a specific type of non-small cell lung cancer patients.

But previously undisclosed changes made by Bristol to the study, known as Checkmate-227, are raising questions about the validity and strength of the results.

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The outcome of Checkmate-227 is key to Bristol as it tries to catch up to Merck and other pharma companies in the lucrative lung cancer immunotherapy market. Billions of dollars in revenue are at stake, and Merck is in the lead, already having secured regulatory approval to treat newly diagnosed lung cancer patients with its checkpoint inhibitor Keytruda combined with chemotherapy.

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