US regulators have approved the first combination of two immuno-oncology agents - Bristol-Myers Squibb’s Opdivo and Yervoy - to treat certain patients with advanced skin cancer.
The dual therapy has been cleared to treat patients with BRAF V600 wild-type unresectable or metastatic melanoma, under accelerated approval based on tumour response rate and durability of response.
The decision comes after data from the CheckMate-069 trial showed a statistically significant increase in confirmed objective response rate in patients treated with the Opdivo (nivolumab)/Yervoy (ipilimumab) regimen compared to those given Yervoy alone (60% versus 11%, respectively).
The combination also showed a 60% reduction in the risk of progression verus Yervoy monotherapy: median progression-free survival was 8.9 months versus 4.7 months, respectively.
Opdivo and Yervoy are both US-approved monoclonal antibodies and immune checkpoint inhibitors targeting separate, distinct checkpoint pathways, inhibition of which results in enhanced T cell function greater than the effects of either drug alone.