Key clinical-trial evidence for nivolumab

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK); Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2015.

In December 2014, the US Food and Drug Administration (FDA) granted accelerated approval for the use of nivolumab (OPDIVO®; Bristol-Myers Squibb; USA) in the treatment of melanoma based on positive results of a multicentre, randomised trial that established the superiority of nivolumab over standard therapy in adult patients with unresectable or metastatic melanoma.

Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumour immune response.

Nivoluamb is approved for the treatment of patients with melanoma who have been previously treated with the anti-CTLA-4 inhibitor ipilimumab and, for patients with melanoma with BRAF V600 mutations who have progressed after treatment with ipilimumab and a BRAF inhibitor (eg vemurafenib or dabrafenib).

Clinical trial experience

CheckMate-037: efficacy

CheckMate–037: adverse reactions

The table below summarises the adverse reactions that were observed in at least 10% of nivolumab-treated patients compared with chemotherapy.

Adverse reactions reported in >10% of subjects on nivolumab and with greater frequency than the chemotherapy arm
ADVERSE REACTIONNIVOLUMAB (n = 268)CHEMOTHERAPY (n = 102)
  All Grades (% patients) Grades 3-4 (% patients) All Grades (% patients) Grades 3-4 (% patients)
Rash 21 0.4 7 0
Pruritus 19 0 3.9 0
Cough 17 0 6 0
Upper respiratory tract infection 11 0 2 0
Peripheral oedema at injection site 10 0 5 0
Increased AST 28 2.4 12 1
Increased alkaline phosphatase 22 2.4 13 1.1
Hyponatraemia 25 5 18 1.1
Increased ALT 16 1.6 5 0
Hyperkalaemia 15 2 6 0
Diarrhoea or colitis 21 - 18 -

Other clinically important adverse reactions in < 10% of patients treated with nivolumab were:

CheckMate-066: efficacy and adverse events

Future directions for nivolumab

New data

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