ORLANDO, FLORIDA—Over the last couple of weeks, regulators in the U.S., Canada and Australia have all green-lighted AstraZeneca’s Calquence in newly diagnosed chronic lymphocytic leukemia (CLL) patients. And Saturday, the company revealed more of the data that convinced them to dole out those approvals.
In a phase 3 trial, 93% of CLL patients taking a combination of Calquence and Roche’s Gazyva hadn’t seen their disease worsen two years after therapy, while just 47% of those taking chlorambucil and Gazyva could say the same. Meanwhile, 87% of people receiving solo Calquence met that benchmark, AZ said at the American Society of Hematology (ASH) annual meeting.
“What this means is that 93% of patients are still progression-free at two years after starting therapy on Calquence. I think that that landmark data is really very important and very impressive,” said Dave Fredrickson, executive vice president and global head of AstraZeneca’s oncology business unit.
The presentation at ASH followed the drugmakers' unveiling of survival numbers that underpinned Calquence’s Nov. 21 FDA approval in front-line CLL. That same study, dubbed Elevate-TN, showed the Calquence-Gazyva pairing could cut patients’ risk of disease progression or death by 90% and that Calquence monotherapy could slash the same risk by 80%.
Those numbers “exceeded our high expectations,” Fredrickson said, adding that the 90% figure represented “the best hazard ratio I’ve seen, I think, in a study in a long time.”
Also important to AstraZeneca was Calquence’s strong safety and tolerability performance, which included low rates of cardiac side effects and major bleeding, Fredrickson said.
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Because CLL patients are often older and often have other health concerns—not to mention the fact that they’re treated “for rather long periods of time,” particularly where BTK inhibitors such as Calquence are concerned—“the need for both an effective but also tolerable therapy is really paramount,” he said.
“Even small changes up or down in safety have an effect on discontinuations, and patients really only get the efficacy of the drugs if they’re able to stay on those medicines,” Fredrickson pointed out.
Thanks to the FDA approval late last month, AstraZeneca’s sales reps are already talking up Calquence to CLL-treating physicians. In fact, they made their first CLL calls on doctors the day the OK came down.
“We literally hit the ground the day of approval,” Fredrickson said. “We’re getting very good receptivity from physicians who are wanting to hear about the data, who are interested in going deeper into what fits within the label.
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Those same reps will be working to convince physicians to prescribe Calquence instead of its in-class rival, the long-established blockbuster Imbruvica from Johnson & Johnson and AbbVie’s Pharmacyclics. BeiGene's Brukinsa, which recently picked up an FDA approval in mantle cell lymphoma, is also eyeing an eventual move into the setting.
But there's competition outside the class, too, SVB Leerink analyst Andrew Berens reminded clients in a weekend research note. Earlier this year, a combination of Gazyva and AbbVie and Roche's Venclexta won an FDA nod in newly diagnosed patients.
"The recent approval of venetoclax plus CD-20 in the frontline setting (May 2019) offers a chemotherapy-free, fixed-duration treatment option for the disease, a benefit some patients and clinicians have preferred over BTK usage, which is until disease progression," Berens said.