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Bristol Wins First Of Two Important Opdivo/Yervoy First-Line NSCLC Approvals

 
• By Mandy Jackson

Data from CheckMate-9LA and -227 that will be presented at the ASCO virtual meeting support a low-dose chemo combo with the two drugs and the newly US FDA-approved chemo-free indication. 

White lung cancer awareness ribbon and lung symbol on red background. November lung cancer awareness month. Healthcare and medicine concept.
ASCO results show durable efficacy in first-line lung cancer • Source: Shutterstock

Having faced defeat with Opdivo (nivolumab) monotherapy, Bristol-Myers Squibb Co. has pinned its hopes for taking back some share of the lung cancer market lost to Merck & Co. Inc.’s Keytruda (pembrolizumab) to combination use of its PD-1 inhibitor with its CTLA-4 inhibitor Yervoy (ipilimumab) based on results from the CheckMate-227 and CheckMate-9LA studies. Now the company stands ready to deliver on that promise, with the US Food and Drug Administration approval on 15 May of Opdivo plus Yervoy in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression of 1% or more and no ALK or EGFR alterations.

Three-year data testing Opdivo plus Yervoy versus chemotherapy in the CheckMate-227 clinical trial – the study that supported the new approval – and the first detailed results from the CheckMate-9LA trial of Opdivo, Yervoy and low-dose chemotherapy versus high-dose chemotherapy in previously untreated metastatic

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