When it launched in March 2011, Yervoy became the only drug ever to extend survival in patients with advanced forms of melanoma. Now, new data show just how long the breakthrough drug can extend that survival: A few patients using Yervoy could tack on as much as a decade to their lives, according to a long-term study. And more than a few could see a few extra years.
Bristol-Myers Squibb's ($BMY) analysis, the first to show Yervoy's effect on long-term survival, encompassed 1,861 patients from 12 trials. 22% of those patients were still alive after three years on Yervoy, after which point a plateau in the survival curve kicked in. Researchers have so far recorded survival as long as 9.9 years, according to data presented over the weekend at a cancer conference in Amsterdam.
Yervoy works by blocking proteins that inhibit immune system cells, freeing up those cells to boost the immune system's ability to fight tumors. While the drug shrinks tumors in slightly more than 10% of patients, those who benefit from Yervoy tend to live a long time: Their immune systems can adapt to mutations in the tumor, Bloomberg reports. "The durability and consistency of long-term survival observed in this analysis is encouraging as we continue to advance the research and development of our immuno-oncology portfolio," Brian Daniels, senior vice president of Global Development and Medical Affairs for BMS, said in a statement.
The results are also encouraging for Yervoy's sales, which analysts predict will top $1.1 billion this year and make the melanoma treatment Bristol's top seller by 2016, Bloomberg says. The drug racked up $462 million in the first half of 2013--welcome news for Bristol-Myers, still ailing after losing patent exclusivity for blockbusters Avapro and Plavix.
But trying to expand Yervoy's market reach has proved harder than BMS anticipated. In April, the company halted a Phase I study trialing Yervoy with Roche's ($RHHBY) Zelboraf in melanoma sufferers on account of signs of liver toxicity in some patients. And earlier this month, the drug flopped in a prostate cancer trial. In that study, it failed to significantly extend patients' lives, though data suggest the combo may hold a greater benefit for subgroups.
Broadening the market for Yervoy will be especially important as melanoma competitors continue to spring up. Two weeks ago, the FDA put a melanoma duo from GlaxoSmithKline ($GSK)--Tafinlar and Mekinist--on its priority review track for use in combination, meaning the agency will accelerate the tandem's trip down the regulatory pathway. The two drugs, separately approved, target tumors with different mutations, and Glaxo hopes the combination will pack a greater punch and hold off resistance.
- read the BMS release
- get more from Bloomberg
- see Reuters' take
Special Reports: Top 10 Best-Selling Cancer Drugs | Top 20 Orphan Drugs by 2018 - Yervoy