Data presented Saturday at the ASCO annual meeting suggest that Bristol-Myers Squibb’s nivolumab reduced tumour size in 31 percent of patients with advanced melanoma. "While this was not a randomised clinical trial, it had a considerable number of patients and the durability of responses is a sign of very promising clinical activity," lead study author Mario Sznol remarked, adding that "nivolumab is a real breakthrough drug for patients with metastatic melanoma, and probably for other diseases, too."
In the early-stage study, 107 patients with advanced, stage IV melanoma that had worsened despite prior treatment with standard drugs were assigned to receive one of five different doses of nivolumab. Overall, 33 patients experienced tumour shrinkage of at least 30 percent and responses were seen at all doses. The median overall survival across all doses was 16.8 months. Among patients given 3 mgs of the immunotherapy, the dose which has been selected for use in subsequent clinical trials, the overall response rate was 41 percent with a median overall survival of 20.3 months. Phase III trials to confirm the latest findings are currently underway.
While the study lacked a control arm, by comparison Bristol-Myers Squibb’s Yervoy (ipilimumab), which was approved in 2011, typically produces tumour shrinkage rates of 5 percent to 10 percent and a median overall survival of 10 months in patients with advanced melanoma. Separately, Bristol-Myers Squibb is also investigating the combination of nivolumab and Yervoy, with one early-stage study demonstrating that the two-drug combination produced a tumour shrinkage rate of at least half in 53 percent of patients with melanoma.
Analysts suggest that Yervoy and nivolumab could generate peak sales of $6 billion.
Merck & Co. also presented early-stage data at the ASCO conference for its anti-PD-1 antibody lambrolizumab, which helped reduce the size of tumours in 38 percent of patients with advanced melanoma.
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