FDA Approves AstraZeneca's Calquence Combo Therapy For Untreated Mantle Cell Lymphoma

On Friday, the FDA approved AstraZeneca Plc's AZN Calquence in combination with bendamustine and rituximab for adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.

Mantle cell lymphoma (MCL) is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), often diagnosed at an advanced stage. It is estimated that there are more than 21,000 patients diagnosed with MCL in the U.S., UK, France, Germany, Spain, Italy, Japan and China.

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The approval was based on results from the ECHO Phase 3 trial presented at the European Hematology Association 2024 Congress.

Results from the ECHO trial showed Calquence  (acalabrutinib) plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.

Median progression-free survival was 66.4 months for patients treated with the Calquence combination versus 49.6 months with chemoimmunotherapy alone.

The approval additionally converts Calquence's accelerated approval to full approval for adult patients with MCL treated with at least one prior therapy, as granted by the FDA in October 2017.

The ECHO trial enrolled patients throughout the COVID-19 pandemic. After censoring COVID-19 deaths, progression-free survival was further improved in both arms, with the Calquence combination reducing the risk of disease progression or death by 36%.

Although overall survival data were not mature at the time of the analysis, when censored for COVID-19, a favorable trend was seen for overall survival despite 69% of patients in the chemoimmunotherapy arm receiving treatment with a BTK inhibitor on relapse or disease progression.

Price Action: AZN stock is up 0.06% at $66.95 at last check Friday.

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