AstraZeneca (AZ) has shared positive results from a late-stage trial of its Bruton’s tyrosine kinase inhibitor Calquence (acalabrutinib) in previously-untreated mantle cell lymphoma (MCL).
Estimated to affect more than 27,500 people globally, MCL is a rare and typically aggressive form of non-Hodgkin lymphoma which is often diagnosed as a late-stage disease.
The phase 3 ECHO trial has been evaluating Calquence plus standard-of-care chemoimmunotherapy, bendamustine and rituximab, compared to the chemoimmunotherapy alone in adults aged 65 years and over with previously-untreated MCL.
Results from an interim analysis of the study showed that the Calquence combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus standard of care.
A trend was also observed in favour of Calquence plus chemoimmunotherapy for the secondary endpoint of overall survival (OS), but this data was not mature at the time of the analysis and the trial will continue to further assess OS.
Susan Galbraith, executive vice president, oncology research and development, AZ, said: “These impactful results in MCL show that bringing Calquence to the first-line setting significantly delays disease progression and, for the first time, shows potential to extend survival.
“The improvement in progression-free survival together with the differentiated safety profile of Calquence are both important as we strive to transform outcomes earlier in the course of disease treatment.”
Calquence is already approved in the US and several other countries to treat adults with MCL who have received at least one prior therapy and also holds authorisations to treat certain patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma.
“Incorporating Calquence into the first-line MCL setting would give many more patients the opportunity to benefit from the robust efficacy and strong safety profile we’ve seen with this medicine,” said ECHO principal investigator, Michael Wang, MD Anderson Cancer Center.
The results come within days of AZ and Daiichi Sankyo sharing positive results from a late-stage study of their HER2-directed antibody drug conjugate Enhertu (trastuzumab deruxtecan) in a subset of breast cancer patients.
The phase 3 DESTINY-Breast06 has been comparing the drug against chemotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow advanced or metastatic breast cancer.