ICARE Newsletter Summer 2017

Emerging FDA Approvals of Immunotherapy Among Patients With Metastatic MSI-H Cancers

Over the last few years, immunotherapy has emerged as an exciting new class of drugs. As early as 2015, immunotherapy through PD-1 Inhibitors among patients with MSI-H colorectal cancers was shown to be of potential benefit.1 As many individuals with Lynch Syndrome have cancers that are MSI-H and mismatch repair deficient, this class of drugs was thought to represent a class of ‘targeted treatments’ for individuals with this syndrome.

More recently, the FDA granted accelerated approval for the use of a PD-1 Inhibitor (nivolumab) for the treatment of patients with MSI-H or mismatch repair deficient metastatic colorectal cancer that has progressed after standard treatment through fluoropyrimidine, oxaliplatin, and irinotecan.2 The approval was based on results of the Phase II CheckMate-142 trial, where almost a third of patients who received nivolumab experienced some benefit from it.3 These exciting advances illustrate the expanded treatment options that are being evaluated and approved for those with inherited forms of cancer.

1Le et al. N Engl J Med. 2015 Jun 25;372(26): 2509-20. PMID:26028255.
2https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-receives-fda-approval-opdivo-nivolumab-ms.
3Overman et al. Lancet Oncol. 2017 Jun 19. [Epub ahead of print] PMID: 28734759.

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