BMS gets green light in US for Opdivo/Yervoy combination

The US FDA has approved the combined use of Bristol-Myers Squibb's melanoma drugs Yervoy and Opdivo, a highly effective but pricey treatment regimen.

This is the first time that two immuno-oncology drugs have been cleared for use in tandem by the FDA, and comes on the back of the CheckMate -069 study which revealed higher response rates and longer progression-free survival (PFS) with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to Opdivo and Yervoy alone.

The median average for PFS was 2.9 months for Yervoy alone, 6.9 months for Opdivo, and 11.5 months for both together, providing the first concrete evidence that giving immuno-oncology drugs in combination can unlock a synergistic therapeutic effect.

It should be noted that the combination was not without its drawbacks, however, with a third of patients taking the two drugs stopping therapy because of serious side effects, including colitis, diarrhoea and rash.

CTLA4 inhibitor Yervoy was the first checkpoint inhibitor drug to reach the market in 2011, and was joined by PD-1 inhibitor Opdivo in 2014. Yervoy has already established itself as a cornerstone of melanoma therapy, with sales of $621 million in the first six months of the year, while Opdivo is growing fast, bringing in $162 million in the same period.

A key factor in those healthy sales is the high price of both drugs and, as the combination will cost around $250,000 for the first full year and $150,000 thereafter, questions are already being raised about the ability of healthcare payers to foot the bill.

That theme was developed at the American Society of Clinical Oncology (ASCO) meeting earlier this year by Leonard Saltz of Memorial Sloan Kettering Cancer Centre, who warned that combination therapies could eventually drive treatment costs towards $1 million a year.

Often the prices of new cancer drugs are not based on their value but what the manufacturer thinks the market can bear, he argued.

Pharmacy benefit manager Express Scripts is equally vocal, saying that the current rising trend in cancer treatment costs is unsustainable and drug prices should be linked more closely to patient benefits. It has started using the leverage of its large patient base to negotiate discounts for a number of drugs.