OBR Daily Commentary


FDA Approves Nivolumab Plus Ipilimumab And Chemotherapy For First-Line Treatment Of Metastatic NSCLC

(FDA.gov) May 27, 2020 - On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Efficacy was investigated in CHECKMATE-9LA (NCT03215706), a randomized, open-label trial in patients with metastatic or recurrent NSCLC. Patients were randomized to receive either the combination of nivolumab plus ipilimumab and 2 cycles of platinum-doublet chemotherapy (n=361) or platinum-doublet chemotherapy for 4 cycles (n=358).

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H. Jack West, MD (Posted: May 28, 2020)


Another positive trial against chemo alone, this regimen that is just approved ahead of presentation of the data at ASCO 2020 will face the same challenge as nivo/ipi alone based on CheckMate-227: a positive result and another option, but one for which I know no lung cancer specialist who would favor ranking either of these ahead of chemo/pembro for most patients, or possibly pembro monotherapy for patients with high PD-L1 -- at least without further evidence to support the concept that a nivo/ipi based regimen with or without 2 cycles of chemo is incrementally BETTER than what we already have.

I strongly suspect that both of these options will be fiercely marketed but destined to achieve <10% of the market share, even for the total of CM-227 & CM-9LA based treatments. We're looking for something better than our 2019/2020 standards, not better than our 2016 standard of care.



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