The Pharmaceutical Benefits Scheme (PBS) listing for nivolumab and ipilimumab expanded on 1 July 2021. These agents are now subsidised when used in combination for the treatment of unresectable malignant mesothelioma.
The efficacy of this combination was investigated in the CheckMate 743 study, a clinical trial conducted in patients with unresectable malignant pleural mesothelioma. Patients were randomly assigned to receive nivolumab plus ipilimumab or standard chemotherapy (pemetrexed plus cisplatin or carboplatin). The primary endpoint of overall survival was significantly longer in the immunotherapy group. The median overall survival was 18.1 months in the immunotherapy group compared to 14.1 months in the chemotherapy group. In addition, the two-year overall survival rates were 41% for immunotherapy versus 27% for standard chemotherapy.
The incidence of severe or life-threatening treatment-related adverse events was similar in each group (30% for immunotherapy and 32% for chemotherapy). Immune-related reactions are commonly associated with nivolumab and ipilimumab. These reactions can affect any organ system and include gastrointestinal effects (e.g. diarrhoea, colitis), liver effects (e.g. hepatitis, raised liver enzymes), skin reactions (e.g. itch, vitiligo, toxic epidermal necrolysis), and endocrine disorders (e.g. thyroid dysfunction, hypophysitis).
- Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, et al. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet 2021; 397(10272); 375-86.
- Opdivo® (Nivolumab) Australian approved product information. Mulgrave: Bristol-Myers Squibb Australia. Approved May 2021.
- Yervoy® (Ipilimumab) Australian approved product information. Mulgrave: Bristol-Myers Squibb Australia. Approved May 2021.