Opdivo (nivolumab) 3mg/kg, in combination with another Bristol-Myers Squibb immuno-oncology agent, Yervoy (ipilimumab) 1mg/kg, is now registered by the TGA for the treatment of patients with intermediate/poor-risk, previously-untreated advanced renal-cell carcinoma (RCC).
This registration has been granted under the new TGA priority review process aimed at expediting evaluation timeframes of new medicines and indications for serious conditions when there is substantial evidence of a major therapeutic advance.
The TGA approval was based on results of the clinical trial CheckMate 214, which showed Opdivo in combination with ipilimumab reduced the risk of death by 37 per cent compared with sunitinib (HR=0.63 p<0.0001), in intermediate and poor-risk patients, meeting the co-primary end-point for overall survival.
The objective response rate was 42 per cent with Opdivo combination versus 27 per cent with sunitinib (p<0.001). Progression-free survival was 11.6 months with Opdivo plus ipilimumab and 8.4 months with sunitinib (p=0.03, not significant).
Grade 3 or 4 treatment-related adverse events occurred in 46 per cent of patients treated with Opdivo plus ipilimumab and 63 per cent of patients treated with sunitinib.
The clinical results were recently published in the New England Journal of Medicine after the trial was stopped early based on a pre-planned interim analysis that determined a significant survival benefit in the Opdivo combination arm.
Kidney cancer is the ninth most commonly diagnosed cancer in Australia, accounting for 3,512 new cases in 2017.
This is estimated to increase to 4,130 by 2020, with RCC being the most common type in adults.
Opdivo in combination with Yervoy for the treatment of patients with intermediate/poor-risk, previously-untreated advanced RCC is not listed on the PBS. However, the combination therapy for these patients was under consideration at the Pharmaceutical Benefits Advisory Committee meeting last month.
In Australia, this is the second indication registered for the Opdivo and Yervoy combination therapy (the combination is already registered for unresectable or metastatic melanoma).