Astrazeneca’s Calquence Combination Recommended for EU Approval in Untreated MCL Patients

AstraZeneca’s Calquence (acalabrutinib), in combination with bendamustine and rituximab, has been recommended for approval in the European Union (EU). This treatment targets adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion based on the results from the ECHO Phase III trial. Presenters shared the results at the 2024 European Hematology Association Congress.

Calquence Combination Treatment Reduces Risk of Disease Progression by 27% and Improves PFS in MCL Patients

The ECHO Phase III trial showed Calquence in combination with bendamustine and rituximab significantly improved progression-free survival (PFS) and showed a positive trend in overall survival (OS) compared to standard chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL). 

The results showed that the Calquence combination treatment reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy. Patients treated with the Calquence combination had a median progression-free survival (PFS) of 66.4 months (n=299), compared to 49.6 months for those receiving standard chemoimmunotherapy (n=299).

The secondary overall survival (OS) data showed a positive trend for the Calquence combination compared to standard chemoimmunotherapy, further supporting its clinical benefits. The trial enrolled patients during the pandemic period and included a pre-specified analysis that excluded deaths related to COVID-19 to assess the impact. This analysis showed further improvement in PFS for both treatment groups. The Calquence combination reduced the risk of disease progression or death by 36%. Patients treated with the Calquence combination did not

Martin Dreyling, MD, Department of Medicine, University Hospital LMU Munich, and investigator in the trial, said, “Results from the pivotal ECHO trial demonstrated the significant benefits of the Calquence combination in managing this rare and aggressive cancer. Today’s recommendation is an important advance within the mantle cell lymphoma first-line treatment landscape, especially for older patients who need a balance of efficacy and tolerability.”

Mantle Cell Lymphoma Accounts for 3-7% of Non-Hodgkin Lymphomas with 4-8 Cases per Million Annually

MCL is a form of non-Hodgkin lymphoma originating from mature B cells, with a clinical course that can vary. MCL may affect lymph nodes as well as extranodal sites, such as the gastrointestinal tract, blood, and bone marrow. This disease represents 3 to 7 percent of non-Hodgkin lymphomas in the United States and Europe, with an incidence estimated at 4 to 8 cases per million people annually. The incidence increases with age and seems to be rising in the U.S. The median age at diagnosis is 68 years. Approximately three-quarters of MCL patients are male, and White individuals are nearly twice as likely to develop the disease as Black individuals.

Current treatments for mantle cell lymphoma (MCL) include chemotherapy, immunotherapy, and stem cell transplantation. The standard approach often involves a combination of chemoimmunotherapy, such as bendamustine plus rituximab, and in some cases, autologous stem cell transplantation. Bruton’s tyrosine kinase inhibitors, like ibrutinib, have also shown effectiveness, especially for patients with relapsed or refractory MCL. 

However, these treatments are not always fully effective. Chemotherapy can be toxic, and many patients relapse after treatment. Additionally, although Bruton’s tyrosine kinase inhibitors offer promising outcomes, some patients develop resistance over time. 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said, “Today’s positive recommendation from the CHMP further reinforces the potential of Calquence to advance first-line treatment options in mantle cell lymphoma, with the Calquence combination demonstrating an almost one and a half year improvement in progression-free survival in this setting. If approved, Calquence has the potential to transform the standard of care as the first BTK inhibitor approved for these patients in Europe.”

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Denisse Sandoval