J&J, AbbVie's Imbruvica builds on case for first-line CLL use at ASH

AbbVie ($ABBV) has said about 30% of the expansion it envisions for cancer standout Imbruvica would come from moving into earlier lines of therapy with the drug. And over the weekend at the American Society of Hematology (ASH) annual meeting, it rolled out some solid new data to support doing just that in chronic lymphocytic leukemia (CLL).

In a study of 269 previously untreated patients aged 65 and older, the med cut the risk of death by 85% compared with chemo treatment chlorambucil. After 18 months--close to the median progression-free survival marker for chlorambucil--90% of Imbruvica patients had not yet seen their disease worsen.

The Illinois pharma and Johnson & Johnson ($JNJ), which shares the drug, are hoping the results will help Imbruvica snag an indication as a first-line treatment in the disease, and on that front, they should have a verdict by early next year. Lead study investigator Jan Burger, for one, thinks there's good reason to believe they'll get a green light.

"If you move this drug into previously untreated patients, it looks even better than what we've seen before," he told Reuters. "… In every measurable way it is so clearly better (than chemotherapy) that the data argue for supporting approval."

Imbruvica has already proven its worth in previously treated CLL sufferers. At May's ASCO conference, AbbVie and J&J unveiled interim results showing 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. 

Imbruvica's trial track record--and the potential to shift the therapy to the first-line setting, where a larger number of patients stay on the drug for longer--is part of what convinced AbbVie to shell out $21 billion for Imbruvica's maker, Pharmacyclics, earlier this year. As CEO Richard Gonzalez told investors in March, he expects the med to rake in $7 billion in peak sales for the company--and that's not taking into account the revenue the med will haul in for J&J.

With biosimilars looming for AbbVie's lead med Humira, that's revenue the drugmaker can use. Last week, Amgen ($AMGN) filed its application for a knockoff with the FDA, and plenty of others are in the mix, too: Baxalta ($BXLT) and Momenta ($MNTA)  in October announced they were taking a copy of the therapy into Phase III trials, and Novartis ($NVS) and a Merck ($MRK)/Samsung Bioepis team are working on their own versions, too.

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