Confident Bristol-Myers to Launch 700-Patient Phase III IDO Trial for Melanoma

Bristol Myers

Bristol-Myers Squibb Company is initiating a Phase III clinical trial of BMS-986205 with nivolumab in patients with advanced melanoma. Although the trial is not yet open, it has been announced on the website.

The compound, BMS-986205, is a IDO1 inhibitor. Nivolumab is the company’s powerful cancer drug, Opdivo. IDO inhibitors are a new class of cancer drugs, although the research on them is fairly new, so not much is known about them, including if they work. And there appears to be some concern that they don’t, although Bristol-Myers’ launch of a trial in this case suggests they, at least, think they do.

Stat writes, “The next incremental answer to that question is coming this week, when Bristol-Myers Squibb will present early-stage data on a combination of its IDO drug and the multibillion-dollar cancer-killer called Opdivo. The results, known only to Bristol and its collaborators right now, were apparently positive enough to convince the company to launch a 700-patient Phase III trial, testing the combination against advanced melanoma.”

Stat argues that the data must be significant, given that Phase III clinical trials are expensive and high-risk. Both Merck and Incyte are running similar trials with Keytruda and a different IDO inhibitor, with a data readout expected in the first half of 2018. “And thus if Bristol had concerns about the overarching idea, it could simply wait to see its competitors’ results. The fact that the company is wasting literally no time suggests Bristol is convinced IDO is for real.”

The trial, according to the ClinicalTrials.gove website, “is to see if BMS-096205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating melanoma that has spread or is unable to be removed by surgery, and has not previously been treated.”

Back in April, Bristol-Myers’ oncology development head, Faoud Namouni, told Endpoints News John Carroll, “It seems our IDO has the potential to be one of the most potent in the class.”

Perhaps clouding the issue is a failed IDO inhibitor trial with Genentechs Tecentriq and NewLink Genetics’ IDO inhibitor indoximod, which resulted in Genentech turning the rights to the drug back.

Derek Lowe, writing for Science Translational Medicine, said, “Something’s wrong, but what? Incyte is developing an IDO inhibitor of their own (epacadostat) and combining it with Merck’s Keytruda is providing the results that one would hope for. So the mechanism is likely to be sound. Complicating the picture, though, is that the Roche/Genentech PD-L1 antibody used in this study (Tecentriq, atezolizumab) had a recent unexpected failure in bladder cancer. It will be tempting for NewLink (and their investors) to think that the antibody was the problem, but there’s just not enough evidence to make that case one way or another. NewLink itself is under a lot of pressure after they’ve had disappointing results with their other IDO inhibitor, indiximod, in breast cancer, and it might be tough to round up another partner at this point. There’s a fair chance that we may never find out why GDC-0919 did what it did, but I hope that we eventually get some idea.”

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