ASH: Johnson & Johnson, AbbVie's Imbruvica steals the CLL spotlight with phase 3 study wins

Johnson & Johnson and AbbVie’s Imbruvica already competes in previously untreated chronic lymphocytic leukemia (CLL). But with a new lineup of head-to-head data, the partners are looking to own it.

On Monday at the American Society of Hematology annual meeting, Imbruvica paired with Rituxan topped a "gold standard" chemo combination of fludarabine, cyclophosphamide and rituximab (FCR) in previously untreated patients aged 70 or younger. And that was just one of the studies the partners trotted out to show Imbruvica's prowess in the first-line setting.

With close to three years of follow-up, the Imbruvica-Rituxan combo showed it could slash the risk of disease progression or death by 65% and the risk of death by 83%.

"This is the gold standard, most efficacious potent therapy that we had in CLL up until this point," Danelle James, M.D., head of clinical science at AbbVie’s Pharmacyclics, said of FCR. "To really take out the gold standard is a great place to be in, in terms of having that proof and that evidence for physicians and patients."

Earlier in the meeting, J&J and AbbVie had touted more positive front-line results, this time from the phase 3 Illuminate study. Imbruvica, paired with Roche’s Gazyva, rang up a 77% reduction in the risk of disease progression or death when pitted against Gazyva and chlorambucil.

The trial was "really the first study to prospectively evaluate a chemo-free regimen versus a chemo combination in patients with high-risk disease," James said, and those high-risk patients showed "a remarkable benefit."

All told, Imbruvica has now come out on top in four phase 3 CLL studies that were "really made complementary."

"They have almost mutually exclusive populations, but they cover the entire spectrum of CLL," James said, adding that in "the front-line setting, it’s almost like no patient left behind."

RELATED: AbbVie, Johnson & Johnson's Imbruvica comes up short in non-Hodgkin lymphoma trial

And that’s exactly what the drug’s makers are shooting for as they work to expand Imbruvica’s reach. After a rare blip over the summer, when Imbruvica missed the mark in a non-Hodgkin lymphoma trial, they’re hoping to rack up additional indications and build on the $1.9 billion the drug has already pulled in worldwide through the first nine months of the year.

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