When given with other cancer drugs for a limited time, AstraZeneca’s Calquence hit the primary endpoint in a registrational test, which could open up a bigger opportunity for the blockbuster drug in chronic lymphocytic leukemia.
In the Phase 3 AMPLIFY trial with 984 untreated CLL patients, AstraZeneca’s second-generation BTK inhibitor plus AbbVie’s Venclexta with or without Roche’s Gazyva given for 12 months reached a “statistically significant and clinically meaningful improvement” in the progression-free survival primary endpoint versus chemoimmunotherapy.
There was also a trend in favor of the fixed-duration Calquence regimen in the secondary endpoint of overall survival, although data were not yet mature. The treatment arm’s safety was consistent with the established profile of each drug, with low rates of cardiac toxicity, according to a Monday release.
Most BTK inhibitors are given to patients continuously until their disease gets worse, which can last for years and increase the risk of long-term side effects. The exception to unlimited use is Venclexta, which was approved in combination with Gazyva as part of two time-limited treatment regimens for CLL in 2019. With the Phase 3 data, AstraZeneca will also look to win approval for a fixed dose regimen.
The UK drugmaker did not disclose p-values but it said it will present full data at a forthcoming medical meeting and share them with regulatory agencies worldwide. During its second-quarter earnings call last week, CEO Pascal Soriot said the AMPLIFY population represented a “blockbuster indication,” according to an AlphaSense transcript. Last year, the BTK inhibitor made $2.51 billion in sales.
Calquence first won FDA approval as a capsule back in 2017 for second-line relapsed or refractory mantle cell lymphoma, a rare form of B cell non-Hodgkin lymphoma. Two years later, the drug secured a label expansion for CLL and small lymphocytic lymphoma. A tablet formulation was greenlit for all three indications in 2022.
In May, Calquence hit the PFS primary endpoint in a registrational trial for first-line MCL, supporting the company’s recent efforts to bring the drug to earlier lines of disease.
Editor’s Note: This article was updated to correct that Calquence has already reached blockbuster status.