AstraZeneca's Calquence treads on Imbruvica's turf with second phase 3 CLL win

AstraZeneca's Calquence currently bears approvals in mantle cell lymphoma. (AstraZeneca)

AstraZeneca’s Calquence has been battling it out in mantle cell lymphoma since it won its first approval back in late 2017, but all along, the company has had its eye on another disease: chronic lymphocytic leukemia. And that’s where it’s scored its latest win.

In a phase 3 trial, Calquence—combined with Roche’s Gazyva—beat out a regimen of chlorambucil chemotherapy and Gazyva at staving off disease progression in previously untreated CLL patients, AstraZeneca said Thursday. And the trial nailed a key secondary endpoint, too, showing solo Calquence could top the Gazyva-chemo combination at the same feat.

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The British drugmaker is keeping the details under wraps for now; they’ll debut at a future medical meeting. But in the meantime, later this month, the company plans to unveil full results from another Calquence CLL win that it top-lined in early May.

In that study, dubbed Ascend, solo Calquence bested a pairing of Roche’s Rituxan and chemo at keeping disease at bay in patients who had failed on prior therapies. Findings from that study and the latest first-line win “confirm the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments,” José Baselga, AZ’s EVP of oncology R&D, said in a press release, adding that both data sets would form the basis of regulatory filings later this year.

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If AstraZeneca can gain regulators’ favor in CLL, it has some serious competition ahead of it. AbbVie and Johnson & Johnson’s Imbruvica currently dominates the CLL landscape, and in the front-line setting, it’s proven itself in phase 3 studies that “cover the entire spectrum of CLL,” Danelle James, M.D., head of clinical science at AbbVie’s Pharmacyclics, said in December.

AbbVie is also new on the front-line scene with a Gazyva combo of its own. The Venclexta-Gazyva regimen, approved last month under the FDA’s Real-Time Oncology Review pilot, showed in data presented Tuesday at ASCO that it could cut the risk of disease progression or death by 65% versus Gazyva and chlorambucil.

AstraZeneca, though, is counting on Calquence to anchor its hematology program, which also includes leukemia player Lumoxiti in the marketed-drug department. The pharma giant and its subsidiary Acerta Pharma are testing Calquence—which generated $62 million in 2018 sales—in 26 trials, including in diseases such as multiple myeloma, Waldenström macroglobulinaemia and diffuse large B-cell lymphoma.