As expected, Incyte yesterday announced positive top-line results for their lead drug candidate in myelofibrosis (MF). COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as ‘424) in MF patients was conducted under an FDA Special Protocol Assessment (SPA) agreement. The double-blind, placebo controlled Phase III trial enrolled 309 patients with a primary endpoint measuring the response rate defined as the percentage of patients achieving a 35% or greater reduction in spleen volume at 24 weeks as measured by MRI, or computerized tomography. The response rate was 42% in patients randomized to ‘424 versus less than 1% of patients randomized to placebo, leading to a very high level of statistical significance (p < 0.0001). This data is consistent with the Phase II data and the company plans to present the full results at ASCO 2011. To preserve the integrity of the data, we will not see any more details until then. So, we were happy to see that secondary endpoints based on symptomatic improvement were all met, but we did not get any details.
One question on the conference call regarding the secondary endpoints was about the durability of response. The company said response was sustainable and that many Phase II patients have seen durable responses for multiple years. The durability of response question was asked as analysts are trying to predict the results for COMFORT-II, INCY’s second Phase III trial being conducted by their partner, Novartis, in Europe. It is a randomized (2:1), controlled, open-label study designed to evaluate the efficacy, safety and tolerability of INCB18424 as compared to the best-available therapy in patients with MF. We expect COMFORT-II to also be positive as all signs from this trial and from Phase II show that ‘424 provides a durable response in MF patients. Results of COMFORT-II are expected early next year and will supplement the NDA that will be filed with the FDA next year. However, the NDA will not be held up while we wait for that data because the FDA considers COMFORT-I to be sufficient for a potential approval.
INCY has done an incredible job moving ‘424 swiftly past regulatory hurdles as the clinical program only started in May 2007 with the commencement of Phase I trials. Speed is not usually an asset when enrolling clinical trials, yet INCY has managed to be both fast and very good. Because MF is an unmet medical need, we can expect a relatively fast FDA review and ‘424 could be on the market before the end of 2011. We have always been impressed with INCY’s management and their vision. That said, we are now even more impressed by their execution. Completing a full clinical program in less than four years is basically unheard of in drug development. INCY’s stock price was up over 5% in after hours trading as the market is pleased with this excellent data set. We will not chase INCY at current prices as it was strongly recommended as a buy under $12 earlier this year. For now, just sit back and enjoy the ride.
By John McCamant
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