Health Canada Approves Calquence® with the Addition of Chemoimmunotherapy for Patients with Previously Untreated Mantle Cell Lymphoma (MCL)

• First and only BTK inhibitor approved for 1L MCL based on ECHO results, which showed Calquence plus chemoimmunotherapy extended progression-free survival by over 16 months vs. chemoimmunotherapy alone

MISSISSAUGA, ON – Health Canada has granted a Notice of Compliance (NOC) for CALQUENCE® (acalabrutinib tablets) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous stem cell transplant.¹

The approval of Calquence in combination with bendamustine and rituximab – a form of chemoimmunotherapy (CIT) – was granted based on the results from the Phase III ECHO trial, which was published in the Journal of Clinical Oncology in May 2025.² Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care CIT (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). Median progression-free survival (PFS) was 66.4 months for patients treated with the Calquence combination versus 49.6 with CIT alone.¹

The safety profile of Calquence with the addition of bendamustine and rituximab was consistent with the established profiles of the individual medicines.^1,3 The most common adverse reactions of any grade (>5%) reported in the Calquence plus CIT arm were infection (78%), leukopenia (59%), neutropenia (55%), nausea (43%), rash (39%), diarrhea (37%), musculoskeletal pain (34%), headache (30%), fatigue (29%), vomiting (26%), constipation (25%), anemia (24%), thrombocytopenia (23%), arthralgia (18%), second primary malignancy (18%), hemorrhage/hematoma (16%), dizziness (15%), bruising (14%), abdominal pain (12%), asthenia (10%), atrial fibrillation/flutter (7%).¹

“Mantle cell lymphoma is a rare and aggressive type of non-Hodgkin lymphoma most often diagnosed in older adults, which can present significant challenges in treatment and management of the disease, with a significant proportion of patients not receiving a second line treatment,” said Dr. Kuruvilla, Clinical Investigator in the Division of Medical Oncology and Hematology at Princess Margaret Cancer Centre and Professor of Medicine at the University of Toronto. “Today’s announcement is an encouraging development for older patients in need of a well-tolerated and effective primary treatment, as we now have the option to treat with a BTK inhibitor in the first line setting.”

An estimated 500–600 people are newly diagnosed with MCL each year in Canada accounting for approximately 5% to 10% of new NHL cases.^4,5 The median age at diagnosis is 68 years, and occurs more often in men than women.⁶ Calquence is the first and only BTK inhibitor approved in combination with bendamustine and rituximab for previously untreated patients in Canada.⁷

About the ECHO Trial

ECHO is a randomized, double-blind, placebo-controlled, multi-centre Phase III trial evaluating the efficacy and safety of Calquence plus bendamustine and rituximab compared to standard of care (SoC) chemoimmunotherapy (bendamustine and rituximab) in adult patients at or over 65 years of age (n=598) with previously untreated MCL.¹ Patients were randomized 1:1 to receive either Calquence or placebo administered orally twice per day, continuously, until disease progression or unacceptable toxicity.² Additionally, all patients received six 28-day cycles of bendamustine on days 1 and 2 and rituximab on day 1 of each cycle, followed by rituximab maintenance for two years if patients achieved a response after induction therapy.²

The primary endpoint is PFS assessed by an Independent Review Committee; other efficacy endpoints include overall survival (OS), overall response rate, duration of response and time to response.⁸ The trial was conducted in 27 countries across North and South America, Europe, Asia and Oceania, including six centres in Canada.⁸  The trial is ongoing and will continue to assess the secondary endpoint of OS.⁸

About Calquence

Calquence is a second-generation, highly selective inhibitor of Bruton’s tyrosine kinase (BTK).⁹ Calquence binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.⁹

In Canada, Calquence is approved as a monotherapy or in combination with obinutuzumab for patients with previously untreated chronic lymphocytic leukemia (CLL); as a monotherapy for the treatment of patients with CLL who have received at least one prior therapy; as a monotherapy for the treatment of patients with MCL who have received at least one prior therapy; and in combination with bendamustine and rituximab for patients with previously untreated MCL who are not eligible for autologous stem cell transplant.¹

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. In Canada, the company employs more than 2,400 people and was recently named one of Canada’s Top 100 Employers for the second consecutive year. Together, AstraZeneca’s R&D Hub and the Alexion, AstraZeneca Rare Disease Development Hub – both based in Mississauga, Ontario – are leading more than 210 global clinical studies in areas such as breast, lung and prostate cancer, COPD, chronic kidney disease, and rare disease. Visit www.astrazeneca.ca for more information.

Contact:

AstraZeneca Canada
Email: corporatecommuncations@astrazeneca.com

References:

1. AstraZeneca Canada Inc., Calquence® (acalabrutinib tablets), Product Monograph. June 2025.
2. Wang, M., et al. Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma. J Clin Oncol. 2025. Accessed May 2025. Available at: https://doi.org/10.1200/JCO-25-00690
3. Data on file.
4. Lymphoma Canada. Non-Hodgkin Lymphoma. NHL Subtypes. Accessed May 2025. Available at: https://www.lymphoma.ca/lymphoma/non-hodgkin-lymphoma/nhl-subtypes#3
5. Anglin, P., et al. Estimating the Associated Burden of Illness and Healthcare Utilization of Newly Diagnosed Patients Aged ≥65 with Mantle Cell Lymphoma (MCL) in Ontario, Canada.  Curr Oncol. 2023 Jun 8;30(6):5529–5545. Accessed May 2025. Available at: https://doi.org/10.3390/curroncol30060418
6. Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. J Clin Oncol. 2016; 34(11):1256-1269. Accessed May 2025. Available at: https://ascopubs.org/doi/10.1200/JCO.2015.63.5904?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

Original source here.