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BMS Gets First Immunotherapy Approval In Neoadjuvant Lung Cancer, Quickly

Executive Summary

Opdivo gets approved by the US FDA for neoadjuvant non-small cell lung cancer, an important new early-stage indication for the anti-PD-1 agent that cleared the agency in roughly two months.

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AstraZeneca’s Imfinzi Scores Neoadjuvant/Adjuvant NSCLC Two-fer At AACR

The PD-L1 inhibitor showed efficacy in the neoadjuvant/adjuvant setting, where Merck is developing Keytruda as well. BMS’s Opdivo was the first to win approval in neoadjuvant NSCLC.

Can’t Win Them All: Two Merck Oncology Trials Fail

The company stopped a study of Lynparza in colorectal cancer for futility and announced a study of Keytruda/chemoradiation in head-and-neck cancer didn’t meet its primary endpoint.

AstraZeneca Looks To Muscle In On BMS-Dominated Neoadjuvant NSCLC Setting

Without disclosing data, the company reported positive pathological complete response data from the AEGEAN study of its PD-L1 inhibitor Imfinzi in neoadjuvant NSCLC, where BMS’s Opdivo won approval in March.

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