Patent No. EP3858859 (titled "Method Of Treating Cancer Using Immune Checkpoint Inhibitor; Antibody That Binds To Programmed Death-1 Receptor (Pd-1) Or Programmed Death Ligand 1 (Pd-L1)") was filed by Bristol Myers Squibb on Jul 14, 2016. The application was issued on Oct 29, 2025.
Nivolumab is used as a monotherapy for treating subjects with recurrent or metastatic human papillomavirus (HPV) positive squamous cell carcinoma of the head and neck (SCCHN). The method comprises administering a therapeutically effective amount of nivolumab, an anti-PD-1 antibody, to a subject in need thereof. HPV positivity may be identified by measuring HPV levels in a subject sample, including identifying nucleotide sequences or proteins such as p16, Ki-67, Cyclin D1, p53, ProEx C, E6, or E7, or via p16 immunohistochemistry showing strong and diffuse nuclear and cytoplasmic staining in over 50% to 70% of tumor cells. The therapy aims to increase progression-free survival and overall response rates compared to standard-of-care treatments.

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