New standout Imbruvica data bode well for market expansion in CLL

CHICAGO--Johnson & Johnson ($JNJ) and AbbVie's ($ABBV) Imbruvica has already shown in one Phase III study that it can extend progression-free survival in patients with previously treated chronic lymphocytic leukemia (CLL). But now, it's done it again--and convincingly so.

Patients who received a three-drug cocktail of Imbruvica, Teva's ($TEVA) Treanda and Roche's ($RHHBY) Rituxan recorded an 80% lower risk of disease progression or death than those who received placebo with the Treanda/Rituxan combo, according to an interim analysis announced Saturday at ASCO. Based on the benefit, researchers halted the trial early and permitted patients to cross over from the placebo arm to receive Imbruvica.

"That's remarkable," Mark Wildgust, the global medical affairs leader at J&J's Janssen unit, told FiercePharma. "There are few clinical studies you would see that have such superior outcomes."

Results from the study, dubbed HELIOS, follow data announced last year from the Phase III RESONATE trial, which also hit its primary endpoint in progression-free survival. And that's one reason Evercore ISI analyst Mark Schoenebaum in March said expectations for the new data "were reasonably high."

Still, it's welcome news for J&J and AbbVie, which recently shelled out $21 billion--a price some analysts deemed "astronomical"--to buy Imbruvica partner Pharmacyclics. The companies--particularly AbbVie, which will need some top-line help as competition moves in for Humira--are counting on Imbruvica to move up into earlier lines of therapy, where the market potential is bigger.

As Schoenebaum pointed out in March, the Treanda/Rituxan tandem is already used as a first-line therapy, and the fact that adding Imbruvica to the mix didn't cause a major increase in side effects "is very encouraging."

And with data from two studies pointing to significant improvement in progression-free survival, Wildgust agrees. "It's a leading indicator when you bring this drug to the front-line setting that you're likely to see similar transformational outcomes with long PFS," he said.

On that front, the companies have two Phase III studies ongoing in treatment-naïve CLL patients, he said--one for patients eligible for chemo, and one for older patients who can't withstand it.

But the pharmas are looking beyond CLL to up Imbruvica's market share, too, AbbVie CEO Richard Gonzalez stressed on a recent call with investors. The drug could expand into other B-cell malignancies, he said--like multiple myeloma--helping it hit the $7 billion in peak sales that AbbVie has predicted.

"These data are super exciting for CLL, but I think this is really just the beginning of the story," Wildgust said. 

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