Cancer Therapy AdvisorAcalabrutinib Plus Rituximab “Highly Effective” in Older MCL Patients

Preetesh Jain, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, presented these findings at the International Conference on Malignant Lymphoma 2023.

A phase 2 study proposes a promising treatment for older patients with previously untreated mantle cell lymphoma, using the combination of acalabrutinib and rituximab, which has shown impressive early complete responses.

Key Points:

• A phase 2 study on acalabrutinib and rituximab treatment found early complete responses (CRs) in older, previously untreated mantle cell lymphoma (MCL) patients.
• 50 patients, with median age 69 years, were enrolled in this single-arm trial
• The objective response rate (ORR) at 12 weeks was 92%, with a CR rate of 74%. The median number of cycles to reach CR was 3.
• At the last follow-up, 60% of evaluable patients (19/32) showed no signs of minimal residual disease.
• At a median follow-up of 17 months, the median progression-free survival (PFS) and overall survival (OS) were not reached; the 2-year PFS rate was 92% and the 2-year OS rate was 96%.

Additional Points:

• The most common adverse events included fatigue (78%), myalgia (62%), headache (34%), COVID-19 (32%), and bruising (28%).
• Serious adverse events (grade 3-4) were thrombocytopenia, fatigue, headache, and COVID-19 (all 4%).
• Three patients succumbed during the study, due to primary refractory disease, an unknown cause in CR, and RASopathy/chronic myelomonocytic leukemia.

Conclusion:

• The combination of acalabrutinib and rituximab appears to be a highly effective, easily administered, chemo-free therapy option for older, previously untreated MCL patients, inducing deep CR early at 12 weeks. However, longer follow-up is needed to fully understand the safety profile and potential risk of second cancers and relapses.

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Did You Know?
Mantle cell lymphoma accounts for approximately 6% of all non-Hodgkin lymphoma cases.