AstraZeneca's Calquence found success in lymphoma. Will CLL follow?

Just over a year after approval, AstraZenca’s Calquence is giving Johnson & Johnson and AbbVie’s Imbruvica a run for its money in mantle cell lymphoma. But the British drugmaker doesn’t want to stop there.

Among relapsed and refractory MCL patients who are new to BTK inhibitors, Calquence—which U.S. regulators green-lighted last Halloween—is getting about 50% of prescriptions, Dave Fredrickson, EVP and global head of AZ’s oncology business unit, said in an interview at the American Society of Hematology annual meeting.

"We’re starting to get to a place—we’re not quite there yet—where we’re the first choice in front of" Imbruvica for that population, he said, adding, "Given that we’ve been on the market for now just over a year, we’re pretty excited to see that happening."

One factor behind the speedy market-share swipe? Calquence’s side effect profile compared with fellow BTK inhibitor Imbruvica, according to Fredrickson.

"When we speak with clinicians, their real-world experience with the efficacy and the side effects associated with Calquence is really positive. We hear physicians talk about how they get fewer calls from patients. … That makes it a drug that for them, they’re finding pretty easy to manage," he said.

Analysts pointed to Calquence’s lack of certain safety warnings when the drug first won approval. It doesn’t share the precautions about hypertension, tumor lysis syndrome and embryo-fetal toxicity that appear on Imbruvica’s label.

But the real showdown between the two drugs will come in previously untreated chronic lymphocytic leukemia, a much larger market where Calquence posted positive early-phase resultsover the weekend.

Contending in that segment will be no easy task, particularly after a show-stealing performance from Imbruvica at ASH. The drug put up three phase 3 wins, both on its own and as part of combinations, in first-line CLL, bringing its total of positive trials in the population to four.

"The bar is now so high with single-agent" Imbruvica, Danelle James, M.D., head of clinical science at AbbVie’s Pharmacyclics, said in an interview at ASH. "Whether or not we’re going to be able to show superiority" with another therapy "is highly speculative at this point," she said.

But if AZ can eventually snag a CLL approval, it will once again look to Calquence’s profile to buoy the drug against its rivals.

"The only way that you can have any success as a second-to-market or late-to-market entrant is if you’ve got a superior medicine. We believe that the efficacy and tolerability profile, along with what we’re hearing from physicians in terms of their experience in MCL, suggest to us that we do have a potential best-in-class BTK inhibitor," Fredrickson said.

Of course, while AstraZeneca may believe there’s room for improvement over Imbruvica, it’ll have to make that same case to doctors before Calquence can find success in CLL.

"Not all physicians recognize that they have that unmet need," Fredrickson acknowledged, and the company admits that it’ll have to bulk up in the sales force department to get that message across. "If we want to be competitive in CLL … we’re going to have to have a field team that is intelligently sized relative to what our competition has," he said.

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