KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma

Area of Science:

• Hematology
• Oncology
• Immunotherapy

Background:

• Mantle-cell lymphoma (MCL) that relapses or progresses after Bruton's tyrosine kinase (BTK) inhibitor therapy has a poor prognosis.
• Chimeric antigen receptor (CAR) T-cell therapy, specifically KTE-X19 targeting CD19, is being investigated for its potential benefit in this patient population.

Purpose of the Study:

• To evaluate the efficacy and safety of KTE-X19 in patients with relapsed or refractory MCL who have previously received BTK inhibitor therapy.

Main Methods:

• A multicenter, phase 2 trial involving patients with relapsed/refractory MCL after up to five prior therapies, including BTK inhibitors.
• Patients received conditioning chemotherapy followed by a single infusion of KTE-X19 (2x10^6 CAR T cells/kg).
• Primary endpoint was objective response rate assessed by independent radiologic review.

Main Results:

• An objective response rate of 93% (67% complete response) was observed in the primary efficacy analysis of 60 patients.
• In an intention-to-treat analysis of 74 patients, 85% achieved an objective response (59% complete response).
• At 12 months, progression-free survival was 61% and overall survival was 83%; common grade 3+ adverse events included cytopenias (94%) and infections (32%).

Conclusions:

• KTE-X19 demonstrated durable remissions in a majority of patients with relapsed or refractory MCL.
• The therapy is associated with serious and potentially life-threatening toxicities consistent with other CAR T-cell therapies.