Calquence combo approved by FDA for untreated mantle cell lymphoma
For untreated patients who are not eligible for autologous stem cell transplant
The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s Calquence (acalabrutinib) as a treatment for mantle cell lymphoma (MCL), a rare and often aggressive type of blood cancer.
The approval is specifically indicated for use in untreated MCL patients who are not eligible for an autologous hematopoietic stem cell transplantation, in combination with the immunotherapy rituximab and the chemotherapy bendamustine.
Autologous hematopoietic stem cell transplantation is a procedure that uses a patient’s own blood-forming stem cells to help restore the patient’s blood and immune system.
“With today’s approval, Calquence provides a critical new treatment option to mantle cell lymphoma patients in the US,” Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, said in a company press release. “This approval brings a new and effective treatment option to those living with this disease and further reinforces our belief in Calquence as a backbone therapy across multiple blood cancers.”
Calquence had FDA approval for MCL in adults with previous treatment
Calquence had been granted accelerated approval by the FDA for MCL in adults who had previously received at least one prior line of therapy. The new approval converts that accelerated approval (a conditional approval based on promising early clinical data) to a full traditional approval.
The therapy is also approved for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, two other types of blood cancer.
MCL is a rare type of non-Hodgkin’s lymphoma caused by the excessive growth of immune cells in the mantle zone, a specific region of the lymph nodes (organs that house immune cells). Calquence is an oral therapy that works to block the activity of Bruton tyrosine kinase, a protein that helps to drive the growth of these cancer cells.
“New treatment options have long been needed in the first-line treatment of mantle cell lymphoma in the US,” said Meghan Gutierrez, CEO of the Lymphoma Research Foundation. “Patients with this rare and often aggressive cancer can experience severe symptoms by the time they are diagnosed — having an effective therapy that can significantly improve outcomes for patients early in the treatment process is a much-needed advancement.”
The FDA’s approval was based off of data from the Phase 3 ECHO (NCT02972840) clinical trial. The study enrolled more than 600 people with MCL who were randomly assigned to receive twice-daily oral Calquence or a placebo, in addition to standard treatment with rituximab and bendamustine.
Results from ECHO showed Calquence significantly reduced the risk of disease progression or death, by 27%. The median time that patients were alive without disease progression was roughly 1.5 years longer with Calquence (66.4 vs. 49.6 months).
Calquence reduced risk of disease progression, death by 36%
AstraZeneca noted ECHO was conducted during the COVID-19 pandemic, and after discounting deaths due to COVID-19, the difference in survival rates between the Calquence and placebo groups was even greater, with Calquence reducing the risk of disease progression and death by 36%.
ECHO did not reveal any unexpected safety findings related to Calquence. The most common side effects of the therapy include diarrhea, respiratory tract infections, headache, muscle and bone pain, and fatigue. It’s also common for patients given Calquence to experience severely low counts of immune cells and blood components.
“Managing this aggressive cancer requires maximizing efficacy while maintaining tolerability, especially for elderly patients,” said Michael Wang, MD, principal investigator of the ECHO study. “Results from the pivotal ECHO trial highlight the promise of the [Calquence] combination in defining a new standard of care, with today’s approval underscoring the transformative potential of this regimen as a first-line treatment for older patients with mantle cell lymphoma.”
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