AstraZeneca receives positive interim results in Phase III ECHO clinical trial evaluating Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in combination with standard chemoimmunotherapy for the treatment of mantle cell lymphoma (MCL) The results were announced.
This double-blind, randomized, placebo-controlled, multicenter trial included adult patients aged 65 years and older with previously untreated MCL.
It is designed to evaluate the safety and efficacy of Calquence plus standard-of-care chemoimmunotherapy, including bendamustine and rituximab, compared to standard-of-care chemoimmunotherapy alone.
Progression-free survival (PFS) is the primary endpoint of this trial, with key secondary outcomes including overall survival (OS), overall response rate (ORR), duration of response (DoR), and time to response (TTR). The following evaluation items are also included.
The trial is being conducted in 27 countries in the Americas, Europe, Asia and Oceania.
According to the results, statistically significant and clinically meaningful improvements in PFS were observed in patients treated with the Calquence regimen compared to standard care alone.
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There was also a trend toward improved OS with Calquence and chemoimmunotherapy regimens.
The safety and tolerability profile of Calquence was found to be consistent with previously reported data, with no new safety concerns identified.
AstraZeneca is evaluating the BTK inhibitor as part of a broader clinical development program aimed at exploring its potential as a monotherapy and combination therapy for multiple B-cell blood cancers.
Calquence is already available for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the United States, CLL in the European Union and many other countries around the world, and relapsed or refractory CLL and SLL in Japan and China. It has been approved as a medicine.
In addition, it is approved in the United States, China, and several other countries for adult patients with MCL who have received at least one prior therapy.
Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, said: “These impactful results in mantle cell lymphoma demonstrate that the introduction of Calquence into the first-line setting significantly slows disease progression and improves survival rates. “This is the first indication that the period may be extended.”
“Calquence's improved progression-free survival and differentiated safety profile are both important as we seek to transform outcomes in the early stages of disease treatment.”
Last month, the company announced the latest exploratory results from the TOPAZ-1 Phase III trial, showing that Imfinzi (durvalumab) and standard-of-care chemotherapy deliver a 3-year long-term OS benefit in patients with advanced biliary tract cancer (BTC). It was shown that