AstraZeneca is working on moving its BTK inhibitor Calquence into earlier stages of mantle cell lymphoma, releasing what it calls positive interim results from a Phase 3 trial.
The combo of Calquence with chemotherapy and immunotherapy led to an increase in progression-free survival, compared with chemotherapy and immunotherapy alone, AstraZeneca said in a press release. It didn’t provide data on the PFS results, the trial’s primary endpoint, but called them “statistically significant and clinically meaningful.”
The trial is also assessing overall survival with the drug. AstraZeneca said those data aren’t mature, but showed a trend in favor of Calquence versus standard of care alone. Patients in the trial had mantle cell lymphoma, a rare subtype of B cell non-Hodgkin lymphoma, and hadn’t been previously treated.
“These positive progression-free survival results from the ECHO Phase 3 trial could provide a new standard of care for patients with mantle cell lymphoma,” Michael Wang, the director of the Mantle Cell Lymphoma Program of Excellence at the University of Texas MD Anderson Cancer Center and the principal investigator in the trial, said in the press release.
No new safety signals were found, AstraZeneca said.
Calquence is a blockbuster for AstraZeneca, bringing in $2.5 billion last year. It won approval as a second-line therapy for relapsed/refractory mantle cell lymphoma in 2017, setting it up as a rival to the BTK inhibitor Imbruvica from AbbVie and J&J. AstraZeneca paid $7 billion to buy a majority stake in Acerta Pharma back in 2015, primarily so it could snag Calquence.
Since then, the drug has been approved as a monotherapy and as a combination treatment for chronic lymphocytic leukemia as well as for small lymphocytic lymphoma. Other competitors have also entered the scene, including BeiGene’s second-generation BTK inhibitor, Brukinsa, for mantle cell lymphoma, and Eli Lilly’s Jaypirca, which gained approval in 2023. Jaypirca is only approved for patients that have been on at least two prior therapies, including another BTK inhibitor.