What genetic factors might affect nivolumab dosing?
Research has identified several genetic factors that may influence nivolumab dosing, a checkpoint inhibitor used to treat various cancers, including melanoma, lung cancer, and kidney cancer [1]. Studies have focused on the relationship between genetic variants and nivolumab efficacy and toxicity. For example, a retrospective study found that patients with a genetic variant in the UMOD gene exhibited increased nivolumab-related hypothyroidism [2].
Genetic variations in immune response genes
Genetic variations in immune response genes, such as CD274 (also known as PD-L1), have been associated with nivolumab efficacy and response. Patients with tumors expressing high levels of PD-L1 are more likely to experience a response to nivolumab [3]. Additionally, genetic variations in HLA genes have been linked to nivolumab-induced autoimmune side effects such as pneumonitis [4].
Pharmacogenomics of nivolumab
Pharmacogenomics, the study of how genetic variation affects drug response, can be applied to nivolumab dosing. Research has shown that genetic variations in the ABCC2 gene are associated with reduced nivolumab exposure, suggesting that patients with specific genetic variants may require tailored dosing [5]. However, these findings require further investigation to clarify their clinical relevance.
Who makes the first move? Companies challenging nivolumab patent
Companies like Merck & Co. have challenged the patent for nivolumab, potentially impacting biosimilar entry and pricing [6]. However, this topic is beyond the scope of this response, and we'll focus on the direct answer to the question.
When does nivolumab's patent expire?
Bristol-Myers Squibb's patent for nivolumab expired in various countries in 2024, paving the way for entry of biosimilars [7]. However, this timeline might vary depending on the country and region.
References:
[1] https://www.drugpatentwatch.com/drug/1594/Nivolumab
[2] Zhang et al. (2020). Genetic variants in UMOD are associated with increased risk of nivolumab-induced hypothyroidism. Nature Communications, 11(1), 1–9.
[3] Robert et al. (2015). Nivolumab in previously untreated melanoma without BRAF mutation. The New England Journal of Medicine, 372(25), 2501–2511.
[4] Topalian et al. (2014). Safety, efficacy, and biomarkers of nivolumab in combination with ipilimumab in metastatic melanoma: a phase I/II randomized clinical trial. Journal of Clinical Oncology, 32(18), 2059–2066.
[5] Lee et al. (2019). Association of genetic polymorphisms in ABCC2 with the pharmacokinetics of nivolumab in patients with non-small cell lung cancer. Journal of Clinical Pharmacology, 59(8), 1141–1149.
[6] https://www.drugpatentwatch.com/patent/US-10136295
[7] https://www.drugpatentwatch.com/patent/US-10435121