On January 16, 2025, the Food and Drug Administration granted conventional approval to acalabrutinib (Calquence, AstraZeneca) in combination with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are not candidates for autologous hematopoietic stem cell transplantation (HSCT).
The FDA has granted conventional clearance for acalabrutinib as a monotherapy for people with previously treated mantle cell lymphoma (MCL). Acalabrutinib obtained expedited clearance for this indication in 2017.
Effectiveness and Safety
The efficacy was assessed in ECHO (NCT02972840), a randomized, double-blind, placebo-controlled, multicenter trial involving 598 patients with untreated mantle cell lymphoma (MCL) aged 65 years or older, who were not candidates for hematopoietic stem cell transplantation (HSCT). Patients were randomized in a 1:1 ratio to receive acalabrutinib in conjunction with bendamustine and rituximab (acalabrutinib + BR) or a placebo alongside BR.
The efficacy was determined by progression-free survival (PFS), evaluated by an independent review committee. With a median follow-up of 49.8 months, progression-free survival (PFS) was significantly prolonged in the acalabrutinib group (hazard ratio 0.73 [95% CI: 0.57, 0.94], p-value 0.016).
The median progression-free survival (PFS) was 66.4 months (95% CI: 55.1, not estimable) in the acalabrutinib plus BR group and 49.6 months (95% CI: 36.0, 64.1) in the placebo plus BR group.
Severe adverse events were observed in 69% of patients receiving acalabrutinib in combination with BR, whereas fatal adverse reactions occurred in 12% of cases. Significant adverse events documented in ≥2% of patients included pneumonia, COVID-19, fever, secondary primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis, and anemia.
The advised dosage of acalabrutinib is 100 mg administered orally approximately every 12 hours until disease progression or intolerable toxicity occurs.
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.
Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.
Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.
Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.
These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.
Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.
