-ranging trial eva luating the safety and activity of the combination regimen of nivolumab and ipilimumab given either concurrently or sequentially in patients with advanced melanoma (n=127). After an additional year of follow up of the cohort that received the concurrent combination regimen of nivolumab 1 mg/kg plus ipilimumab 3mg/kg (n=17), the one-year overall survival (OS) rate was 94% and the two-year OS rate was 88%. These are the doses used in the ongoing Phase 2 and Phase 3 trials, CheckMate -069 and -067. No new safety signals were reported in the concurrent combination cohorts with additional follow up (n=53) and grade 3-4 treatment-related adverse events (AEs) occurred in 62% of patients. The most common were asymptomatic increases in lipase (15%), ALT (12%) and AST (11%) [6].
09/06/2014 12:30:43
Feb 14: PIII CheckMate-067 (NCT01844505) study is still recuiting pts. It is now expected to complete in Oct 17 [5].
24/03/2014 10:37:06
Jun 13: Results from a PI study ( NCT01024231) of concurrent therapy with nivolumab and ipilimumab in malignant melanoma published in N Engl J Med (June 2, 2013DOI: 10.1056/NEJMoa1302369). The combination had a manageable safety profile and provided clinical activity that appears to be distinct from that in published data on monotherapy, with rapid and deep tumour regression in a substantial proportion of patients.
03/06/2013 10:51:42
Evidence Based eva luations
NHSC/NIHR http://www.hsc.nihr.ac.uk/topics/nivolumab-for-braf-v600-mutation-positive-advanced/
References
Available only to registered users
Category
BNF Category: Other immunomodulating drugs (08.02.04)
Pharmacology: Fully human Ig4 monoclonal antibody; programmed cell death-1 receptor (PDCD 1) inhibitor
Epidemiology: In 2008, the UK age-standardised incidence of melanoma for females was 16.5 (11.7 in 2001) and for males was 15.9 (10.1 in 2001) per 100,000 population. It has been estimated that the lifetime risk of developing malignant melanoma in 2008 was 1 in 61 for men and 1 in 60 for women in the UK [4]
Indication: Malignant melanoma
Additional Details: unresectable or metastatic BRAF-positive, first-line
Method(s) of Administration
Intravenous infusion
Company Information
Name: Bristol-Myers Squibb
US Name: Bristol-Myers Squibb
Further Information
Anticipated commissioning route (England) -
High cost drug list? Awaiting Update
Implications Available only to registered users |
