EC Approves Calquence Combo for MCL Treatment

The European Commission has granted approval for AstraZeneca's Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib), in combination with bendamustine and rituximab, to treat adults with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. This decision was preceded by a favorable opinion from the Committee for Medicinal Products for Human Use and was bolstered by results from the ECHO Phase III trial.

The ECHO trial demonstrated that the combination of Calquence with bendamustine and rituximab significantly reduced the risk of disease progression or mortality by 27% compared to standard chemoimmunotherapy. Participants treated with the combination therapy experienced a median progression-free survival (PFS) of 66.4 months, in contrast to 49.6 months for those receiving only standard chemoimmunotherapy. Additionally, the tolerability and safety profile of Calquence was consistent with previous studies, with no new safety concerns identified.

Dave Fredrickson, Executive Vice-President of AstraZeneca's oncology hematology business unit, highlighted the significance of the findings, emphasizing the substantial improvement in progression-free survival and the consistent safety profile observed in the pivotal ECHO trial. He noted that Calquence is the first and only BTK inhibitor approved for this indication in the European Union, providing a vital new treatment option for patients with this challenging disease.

The approval of Calquence's combination therapy extends its global footprint, building upon its recent authorization in the EU as a single agent for treating adults with relapsed or refractory MCL. Calquence is also approved in various countries, including the United States, Japan, and China, for conditions such as chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), alongside its approval for CLL in the EU and many other regions.

Calquence is being investigated in a comprehensive clinical development program as both a standalone treatment and in combination with standard chemoimmunotherapy for B-cell blood cancers, including MCL, diffuse large B-cell lymphoma, and CLL. This extensive program underscores AstraZeneca's commitment to exploring diverse therapeutic strategies to improve outcomes for patients with these types of cancer.

In addition to the approval of Calquence, AstraZeneca has also received the EC's approval for its Imfinzi plus chemotherapy regimen for treating resectable non-small cell lung cancer (NSCLC) in adults. This approval further exemplifies AstraZeneca's ongoing efforts to expand its portfolio of treatments for various forms of cancer, enhancing therapeutic options for patients worldwide.