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Home Topics A–Z Key clinical-trial evidence for nivolumab
Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK); Dermnet NZ Editor in Chief: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2015. Updated August 2018. Copy edited by Gus Mitchell.
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.
In April 2016, MedSafe approved nivolumab for the treatment of melanoma patients in NZ.
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).
The table below summarises the adverse reactions that were observed in at least 10% of nivolumab-treated patients compared with chemotherapy.
Adverse reactions | Nivolumab (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:
Best Overall Response No (%) |
Nivolumab plus Ipilimumab |
Nivolumab |
Ipilimumab |
Complete response |
61 (19) |
52 (16) |
16 (5) |
Partial response |
122 (39) |
88 (28) |
43 (14) |
Stable disease |
38 (12) |
31 (10) |
69 (22) |
Progressive disease |
74 (24) |
121 (38) |
159 (50) |
Unable to determine |
19 (6) |
24 (8) |
28 (9) |
Median progression free survival (months) |
11.5 (95% confidence interval [CI], 8.7 to 19.3) |
6.9 (95% CI, 5.1 to 9.7) |
2.9 (95% CI, 2.8 to 3.2) |
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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