|The full article is available to subscribers||Subscriber Login|
The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda),1 and the first to be approved for treatment of NSCLC.
STANDARD TREATMENT — Metastatic melanoma – High-dose interleukin-2 (aldesleukin – Proleukin) has produced responses in 15-20% of patients with metastatic melanoma, but its use has been limited by severe toxicity and cumbersome administration requiring hospitalization for treatment. The... more
- Pembrolizumab (Keytruda) for metastatic melanoma. Med Lett Drugs Ther 2014; 56:e114.
- Ipilimumab (Yervoy) for metastatic melanoma. Med Lett Drugs Ther 2011; 53:51.
- D Schadendorf et al. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in unresectable or metastatic melanoma. J Clin Oncol 2015 February 9 (epub).
- C Robert et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 2015 April 19 (epub).
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Melanoma. Version 3. 2015. Available at www.nccn.org. Accessed May 28, 2015.
- Vemurafenib (Zelboraf) for metastatic melanoma. Med Lett Drugs Ther 2011; 53:77.
- Dabrafenib (Tafinlar) and trametinib (Mekinist) for metastatic melanoma. Med Lett Drugs Ther 2013; 55:62.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Non-Small Cell Lung Cancer. Version 6. 2015. Available at www.nccn.org. Accessed May 28, 2015.
- DM Pardoll. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 2012; 12:252.
- JS Weber et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 2015; 16:375.
- C Robert et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015; 372:320.
- MA Postow et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 2015; 372:2006.
- NA Rizvi et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol 2015; 16:257.
- J Brahmer et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015; 373: 123.