J&J's Imbruvica thumps GSK's Arzerra in head-to-head leukemia trial

CHICAGO--Results are in from a showdown between chronic lymphocytic leukemia (CLL) drugs Imbruvica (ibrutinib), from Johnson & Johnson's ($JNJ) Janssen unit and Pharmacyclics ($PCYC), and GlaxoSmithKline's ($GSK) Arzerra (ofatumumab). And as it turns out, it wasn't much of a contest.

In a Phase III head-to-head trial of the two therapies in patients with relapsed leukemia, Imbruvica bested Arzerra in progression-free survival, overall survival and overall response rate. Patients receiving Imbruvica saw a 78% reduction in the risk of cancer progression or death compared with patients on Arzerra, with both drugs groups experiencing similar side effects.

Imbruvica has so far impressed its way through the clinic, racking up not one but three breakthrough designations on the way to FDA approval. But despite the success it's registered so far, these new data surpassed researchers' expectations, Dr. Craig Tendler, Janssen's VP of late-stage development and global medical affairs for oncology, hematology and supportive care, told FiercePharma.

"It's very encouraging to be able to start seeing a drug that is very well tolerated and can be given for a long period of time," he said in an interview. "… We believe that these data support the use of the drug as a standard of care."

As a pill rather than an injectable drug, Janssen's med has another leg up over its competition, and analysts surveyed by Bloomberg expect it to rake in $3.37 billion by 2018. Other rivals are on the way, however, including Gilead's ($GILD) idelalisib, which is currently under FDA review.

But according to Tendler, Janssen will keep up the research to figure out how to improve on Imbruvica's current results--and keep it ahead of the competition, the company hopes.

"The goal is to get a significant proportion of these patients cured. These initial results at least give us hope that ibrutinib could be a part of a regimen to maybe deliver a cure for CLL patients," he said. "We're not stopping here."

- read the release

Special Reports: FDA approvals of 2013 - Imbruvica | Top 20 orphan drugs by 2018 - Ibrutinib

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