J&J has reaped the final harvest of Phase III data it is taking to regulators in search of a blockbuster approval for their psoriasis contender guselkumab.
J&J is widely expected to use this latest batch of reliably positive data to clean up on major approvals at the FDA and EMA. But its favorable late-stage comparisons with Humira may not count for so much these days, as the pharma giant is bringing up the rear of a parade of new drugs that got to the market first.
Novartis’ Cosentyx got out ahead 18 months ago and the Swiss pharma giant has followed with 4-year data tracking a solid success — 43.5% — in keeping skin cleared over the long haul. Eli Lilly backed its new drug Taltz in a major campaign last fall. And then Valeant ambled across the finish line with brodalumab — now dubbed Siliq — two weeks ago. Their drug, picked up at a discount from a disappointed AstraZeneca, also comes with a black box warning on suicidal thinking that will almost certainly squeeze its slice of the market down to a sliver.
Now comes J&J, a global powerhouse, with a contender it believes is already positioned for success.
As we saw in the first Phase III, VOYAGE 1, guselkumab handily outscored a placebo on two measures of complete or near-complete skin clearance in VOYAGE 2. And once again their IL-23 drug slapped aside Humira, with guselkumab versus adalimumab achieving an IGA 0/1 score of 84% versus 67.7% and a PASI 90 of 70% compared to 46.8%, respectively.
“The results were remarkably similar, which is what you want to see,” Philippe Szapary, VP for dermatology and gastroenterology in J&J’s Immunology Clinical Development unit, tells me about his Phase III studies. “It’s very reassuring to see such amazing consistency.”
J&J’s third Phase III study looking at patients transferred to guselkumab after an inadequate response to their other psoriasis drug Stelara also looked good. The statement notes:
Patients who switched to guselkumab consistently showed greater improvement in their psoriasis between weeks 28 and 40, compared with patients who continued to receive Stelara, having twice as many office visits with at least a 2 point improvement in IGA from week 16, the study’s primary endpoint, and an IGA score of 0 or 1.
J&J gained a new approval for Stelara last fall, adding Crohn’s to the label as the company looked to keep its performance in blockbuster territory. The new Navigate study also positions J&J to keep about 30% of psoriasis patients who don’t respond well to Stelara in the fold, so to speak.
Investigators also reaped a satisfying profile on safety, with a somewhat better set of data on adverse effects compared to Humira, which remains a big player in this field as AbbVie continues to fight off biosimilar competition. There is also one more psoriasis drug waiting in the wings. Sun Pharma gained control of Merck’s MK-3222, but it isn’t expected to hit the market anytime soon.
The next step is to keep gathering data with extension studies that will take the 1800 patients enrolled for VOYAGE 1 and 2 out about five years. With a target lying upstream of IL-17 and TNF, he adds, investigators are hopeful that guselkumab will continue to perform well against competition long after it arrives on the market.
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