ASH: J&J, AbbVie tout long-term Imbruvica data in the face of a new AstraZeneca threat

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Both the Johnson & Johnson-AbbVie team and AstraZeneca presented MCL data over the weekend at the ASH annual meeting in Atlanta.

ATLANTAJohnson & Johnson’s Janssen unit and AbbVie’s Pharmacyclics have racked up some new long-term Imbruvica data that will come in handy as they try to ward off a new competitor.

On Saturday at the American Society of Hematology (ASH) annual meeting, the partners rolled out results of a new analysis showing that in mantle cell lymphoma patients who received Imbruvica after just one relapse, rather than later on in the course of their disease, the drug was more effective and better tolerated.

At the study's 41-month mark, Imbruvica had staved off cancer progression by a median 13 months, but that number jumped to 33.6 months among patients who'd received only one prior round of treatment with another drug. Serious adverse events related to treatment “were generally less common in patients who were treated earlier” with the med, Janssen said.

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The data support earlier use of the drug, and it also answers questions for physicians, who use the treatment for extended periods of time.

“Long-term data are quite relevant,” considering that, like patients with hypertension or diabetes, patients on BTK inhibitors such as Imbruvica “have to take your pills often for a lifetime,” Thorsten Graef, Pharmacyclics’ head of hematology and global medical safety, said in an interview.

“Oncology, of course, is kind of a different beast, but there’s a big change in how you treat oncology patients over a lifetime. Safety elements become more and more important. ... You really want to understand what your drug does when you apply it for two, three, four years,” he added.

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New rival AstraZeneca, of course, can’t yet tout long-term data for its own drug Calquence, which snagged an FDA approval in MCL in late October. But it’s hoping to ride strong results from the trial that helped it snag approval, in which Calquence provoked an overall response rate of 81% and a complete response rate of 40%.

So far, uptake has already been “better than anticipated,” Andrew Coop, VP of U.S. medical affairs for AZ’s oncology unit, said in an interview, and the British drugmaker intends to keep up that trajectory. The company got the drug out to patients within a week of its approval, which he said “speaks to the urgency” with which people want to treat MCL patients.

And when it comes to launches, AZ knows a thing or two, he pointed out; it’s already launched six new indications this year, putting on display the “passion, the speed, the way that we organize ourselves to make sure we get things moving quickly.”

He expects Calquence’s rollout to be no different. “This is our first entry into hematology,” he said. “This is really important for AstraZeneca.”