Treatment for Patients Who Have Not Received a Prior BTK Inhibitor

An observational cohort study included 385 patients with MCL and disease relapse after 2 years. Patients received BTK inhibitors (usually ibrutinib) or chemoimmunotherapy in a nonrandomized fashion.[3]

An observational cohort study included 385 patients with MCL and disease relapse after 2 years. Patients received BTK inhibitors (usually ibrutinib) or chemoimmunotherapy in a nonrandomized fashion.[3]

With a median follow-up of 53 months, the median overall survival (OS) was better in patients who received BTK inhibitors (not reached [NR]) than in patients who received chemoimmunotherapy (56 months) (P = .03).[3][Level of evidence C1]

Acalabrutinib, a selective BTK inhibitor, was studied in a phase II trial of 124 patients with relapsed/refractory MCL. The results of this trial led the U.S. Food and Drug Administration (FDA) to approve acalabrutinib in 2017, before the approval of ibrutinib.[4]

Acalabrutinib, a selective BTK inhibitor, was studied in a phase II trial of 124 patients with relapsed/refractory MCL. The results of this trial led the U.S. Food and Drug Administration (FDA) to approve acalabrutinib in 2017, before the approval of ibrutinib.[4]

With a median follow-up of 15.2 months, the overall response rate was 81% (95% confidence interval [CI], 73%–87%), the complete response rate was 40% (95% CI, 31%–49%), and the 1-year progression-free survival (PFS) rate was 67% (95% CI, 58%–75%).[4][Level of evidence C2]

Acalabrutinib, a selective BTK inhibitor, was studied in a phase II trial of 124 patients with relapsed/refractory MCL. The results of this trial led the U.S. Food and Drug Administration (FDA) to approve acalabrutinib in 2017, before the approval of ibrutinib.[4]

Acalabrutinib is a more selective BTK inhibitor with lower rates of atrial fibrillation than ibrutinib (3%–4% vs. 10%–12%).

Zanubrutinib, a selective BTK inhibitor, was evaluated in a phase II trial of 86 patients with relapsed/refractory MCL.[5]

Zanubrutinib, a selective BTK inhibitor, was evaluated in a phase II trial of 86 patients with relapsed/refractory MCL.[5]

With a median follow-up of 35.3 months, the overall response rate was 84%, the complete response rate was 98%, and the median PFS was 33 months (95% CI, 19.4–not estimable [NE]).[5][Level of evidence C2]

Zanubrutinib, a selective BTK inhibitor, was evaluated in a phase II trial of 86 patients with relapsed/refractory MCL.[5]

Zanubrutinib is a more selective BTK inhibitor with lower rates of atrial fibrillation than ibrutinib (3%–4% vs. 10%–12%).

Multiple phase II studies of ibrutinib in patients with relapsed or refractory MCL, including a pooled analysis of 370 patients, showed overall response rates of 66% to 68% and median PFS of 12.5 months to 13.9 months.[6-8] Long-term follow-up of the pooled analysis showed an OS of 61.6 months.[9]