J&J has long had high hopes for its anti-inflammatory IL-23 drug guselkumab. And today in Vienna they detailed the first round of Phase III data for severe plaque psoriasis that explains why.
Investigators say this drug not only handily beat a placebo, it also outstripped the megablockbuster Humira in key measures of efficacy. And that will help position the pharma giant as it starts to line up regulatory approvals for a new therapy that’s likely headed into a heavily competitive market.
In the VOYAGE 1 study, J&J says that the co-primary endpoints were met at week 16, with 85.1% of patients receiving guselkumab 100 mg at weeks 0 (the start of therapy) and 4 and then every eight weeks achieving cleared (IGA 0) or minimal disease (IGA 1) compared with 6.9% of patients receiving placebo. Nearly three-quarters of patients receiving guselkumab (73.3%) achieved a PASI 90 response, or near complete skin clearance, compared with 2.9% of patients receiving placebo.
That’s also good news for MorphoSys, which partnered with J&J on the drug.
All major secondary endpoints in VOYAGE 1 achieved statistical significance in comparisons of guselkumab with Humira (adalimumab). Here’s the summary:
At week 16, following three injections of guselkumab and ten injections of adalimumab, significantly higher proportions of patients receiving guselkumab achieved IGA 0/1 and PASI 90 (85.1 percent and 73.3 percent, respectively) compared with patients receiving adalimumab (65.9 percent and 49.7 percent, respectively). At week 24, the proportion of patients who achieved a PASI 90 response was significantly higher in the guselkumab group compared with the adalimumab group (80.2 percent vs. 53.0 percent, respectively). Higher levels of skin clearance among the guselkumab group continued through weeks 24 and 48, with significantly more patients receiving guselkumab achieving IGA 0/1 and PASI 90, as well as measures of full skin clearance, as indicated by a 100 percent improvement in PASI score (PASI 100) or an IGA score of 0, compared with adalimumab.
J&J is looking to increase its presence in a market where it’s been building sales for Stelara while maintaining an old mainstay, Remicade, an anti-TNF drug like Humira. This new drug is slated to arrive as biosimilars for both of the old drugs are angling to hit the market, though AbbVie has vowed to fight to the bitter end over Humira’s patent protection.
“I think (guselkumab) actually works better than what we had seen from the data in Phase II,” says Philippe Szapary, the VP of immunology clinical development at Janssen, who says both the PASI 90 and clearance rates are higher than the mid-stage results, which may be explained by an extra loading dose used in Phase III.
That difference has helped establish “good maintenance over time” with a relatively quick onset for many that could help demonstrate to patients that they’re on the right track.
Even with data from two more late-stage trials on track for a later release, Szapary says that J&J is on track for regulatory submissions by the end of this year.
“There’s a lot more to come out,” Szapary adds, as J&J lays out its case that this drug is biologically available to a wide range of patients, from frontline use on to others.
This fast-moving field has seen plenty of drama over the past year. At one point AstraZeneca and Amgen thought they were on track with brodalumab, then incidents of suicidal ideation drove Amgen out and persuaded AstraZeneca to sell rights to the drug to a troubled Valeant, which won a recent panel vote.
In the meantime, Eli Lilly made it onto the market with Taltz (ixekizumab) with Novartis out with the first new contender, Cosentyx. Merck is still in the clinic with MK-3222.
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