AbbVie eyes Imbruvica expansion in CLL as Gazyva pairing hits its marks

Imbruvica
Imbruvica is already approved as a monotherapy in first-line CLL. (AbbVie)

AbbVie’s Imbruvica growth strategy in chronic lymphocytic leukemia centers on expanding use of the drug among previously untreated patients. And it now has some new data that should help it do that.

On Thursday, the company said Imbruvica had hit its marks in a phase 3 trial that paired it with Roche product Gazyva. Together, the drugs beat out a combination of Gazyva and chemotherapy chlorambucil at staving off cancer progression. And now, AbbVie—along with partner Johnson & Johnson—is sharing the analysis data with regulators, it said.

The outcome isn’t surprising to AbbVie, whose chief scientific officer, Michael Severino, called the trial “pretty low risk” in a recent interview with Bernstein analysts.

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The reason? Imbruvica has already shown it can outdo chlorambucil in the first-line setting, and by a long shot. Results from a study dubbed Resonate-2—which helped Imbruvica secure its 2016 FDA monotherapy nod in first-line CLL—showed that the drug could cut the risk of disease progression or death by 84% compared with chlorambucil.

RELATED: J&J, AbbVie's Imbruvica breaks into larger CLL market with first-line FDA nod

“We think that (Resonate-2) is a very good indicator of what we are likely to see when we’re able to report out Illuminate,” Severino said earlier this month. 

The new data should help AbbVie widen its first-line label, which is right in line with the Illinois pharma’s aims. The company is working on “rounding out the data profile” among first-line patients, Severino said, adding that it’s expecting "the largest part of the growth for Imbruvica going forward” to come from “that move to the frontline and then deepening of penetration in that frontline.”

Illuminate, of course, isn’t the only study AbbVie’s banking on to help it do that, and it’s working on plenty of other Imbruvica studies outside of CLL, too. While CLL may be “the largest portion of the growth of Imbruvica going forward,” according to Severino, the company is trialing the drug as a treatment for other cancers—including a subset of large B-cell lymphoma.

RELATED: AbbVie paid a 'lofty,' 'staggering,' 'astronomical' price for Pharmacyclics. But was it too much?

Imbruvica’s major potential for expansion prompted AbbVie to shell out $21 billion on maker Pharmacyclics back in 2015. At the time, analysts labeled the price “lofty,” “staggering,” and even “astronomical,” especially considering that Pharmacyclics shared Imbruvica with Johnson & Johnson's Janssen. But the drug has racked up new indications, just as AbbVie management promised it would, and in the first quarter, it exceeded analyst expectations by $6 million, tallying $762 million in sales for the quarter.