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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)

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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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