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Bristol Debuts Opdivo/Yervoy Data In New First-Line Lung Cancer Bid

 
• By Joseph Haas

The pharma hopes showing a PFS benefit in first-line NSCLC patients with a high tumor mutation burden may provide a way to compete with Merck in that setting, but analysts think it will need overall survival data.

Hitting bigger business target
BMS Makes New Move For Bigger Market

Bristol-Myers Squibb Co. overshadowed its fourth quarter and full year 2017 results by previewing the long-awaited results of the CheckMate 227 study of its Opdivo/Yervoy combination in first-line lung cancer. But questions about the chances for approval on these early results may mean BMS waits until late this year or early 2019 for the overall survival data, leaving Merck & Co. Inc. an even larger window to stake its claim in the largest market for immuno-oncology.

The ongoing Phase III CheckMate 227 study showed that Bristol's PD-1 inhibitor Opdivo (nivolumab) and CTLA-4 inhibitor Yervoy (ipilimumab) demonstrated a "highly statistically significant" improvement in progression-free survival (PFS), compared to chemotherapy, in first-line non-small cell lung cancer (NSCLC) patients who have high tumor mutation burden (TMB), regardless of PD-L1 expression status

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• By Kevin Grogan

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• By Jessica Merrill

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