Gilead's idelalisib works well enough in leukemia patients to halt study early
This article was originally published in Scrip
Gilead Sciences said its experimental drug idelalisib worked well enough in a late-stage study of leukemia patients that the trial will be stopped early.
The company is halting the study of the drug for chronic lymphocytic leukemia at the advice of an independent panel that found statistically significant efficacy for the trial’s primary goal of progression free survival. The trial tested previously treated patients who are not fit for chemotherapy, comparing study participants given idelalisib with Roche and Biogen Idec’s Rituxan (rituximab) with those receiving Rituxan alone.
Gilead said it informed US FDA officials about the decision, and the company plans to discuss a possible regulatory filing with the agency, which some analysts predict may be late this year or early next year. US government estimates show almost 16,000 people will be diagnosed this year with CLL, the most common form of leukemia among adults.
“Given the significant unmet medical need in CLL, particularly in this population of patients who are not fit for chemotherapy, we are pleased that idelalisib has shown a clinically meaningful benefit for patients,” Gilead chief scientific officer Norbert Bischofberger said.
The company's foray into cancer is another example of the biotech drug maker diversifying beyond its expertise in HIV treatments, where it has been dominant, into new disease areas. Like hepatitis C, oncology represents another emerging therapeutic area for Gilead with strong potential for growth.
"These are attractive, new markets for Gilead and represent enormous commercial opportunities," William Blair & Co analyst John Sonnier said.
A number of companies are developing drugs for various blood cancers, including leukemia. In August, Johnson & Johnson and Pharmacyclics said the FDA accepted an application to market the experimental drug ibrutinib for previously treated CLL and mantle cell lymphoma patients.
Gilead already submitted an application in the US last month to sell idelalisib for treatment of refractory indolent non-Hodgkin’s lymphoma. A European application is planned later this year, the company said.
Results of the CLL study will be presented at an upcoming medical meeting. A presentation at the American Society of Hematology meeting in December may be a possibility, though Gilead spokesperson Nathan Kaiser declined to comment on the company's plan.