Bristol-Myers Squibb released preliminary data ahead of the ASCO meeting from an early-stage trial, demonstrating that the combination of Yervoy (ipilimumab) and the investigational PD-1 receptor blocking antibody nivolumab was more effective than either drug alone in patients with melanoma. "We view the combination of immunotherapy as a significant one that we'll be pursuing," remarked Michael Giordano, senior vice president of global development for oncology and immunology.
Results from 52 patients in the study who have so far received the combination of Yervoy and nivolumab showed that 40 percent had an objective response, while in one dose group, 53 percent of subjects had an objective response. Lead researcher Jedd Wolchok remarked "the responses are occurring faster and the absolute amount of shrinkage is more than we have seen with either drug alone."
"What we are seeing that is so impressive is the number of patients that have had very deep responses, their tumour burden decreasing by 80 percent or more," Wolchok said. Results indicated that 31 percent of patients given Yervoy and nivolumab had their tumours shrink by at least this amount, with Wolchok adding that tumours disappeared entirely in 10 percent of patients. He suggested that typically, only about 11 percent of patients respond to Yervoy, while recent work indicates that nivolumab produces a response rate of about 41 percent.
Wolchok noted that in the trial, the drug combination led to some patients developing elevated pancreas and liver enzyme levels. "These are reversible, sometimes without treatment," Wolchok commented, adding "we really didn't see anything new with the combination" related to safety. Based on the results, Bristol-Myers Squibb plans to conduct a Phase III trial combining Yervoy and nivolumab in patients with advanced melanoma. The company is also conducting five other late-stage studies of nivolumab in lung cancer, kidney cancer and melanoma.
Yervoy was approved in the US and Europe in 2011 for patients with advanced melanoma, while analysts predict that if approved, nivolumab may garner sales of $2.5 billion to $3.5 billion in 2020. Leerink Swann & Co. analyst Seamus Fernandez suggested that the revenue potential for the drug and Bristol-Myers Squibb's other cancer immune therapies may increase if the Yervoy and nivolumab combination works well in a variety of tumours. He noted that the results "could open the door to significant potential upside" by giving the company a competitive advantage over rivals testing compounds against PD-1.
Merck & Co. also released results from an early study of its drug that targets PD-1 called lambrolizumab. Data showed that the agent shrank tumours in at least 35 percent of patients with advanced melanoma. Meanwhile, Roche's compound MPDL3280A, which targets PD-L1, reduced tumour size in 21 percent of patients with late-stage lung cancer, melanoma, kidney cancer, colorectal cancer and stomach cancer.
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