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An expert panel hosted by
Customizing first-line BTK inhibitors for CLL
with Gilles Salles, Paolo Ghia, and Francesc Bosch
Wednesday, October 23, 2024
18:30-19:30 BST
This independent educational activity is supported by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech. All content is developed independently by the faculty. The funder is allowed no influence on the content of this activity.
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On June 16, 2023, it was announced that the U.S. Food and Drug Administration (FDA) has granted approval to glofitamab, a T cell-engaging bispecific antibody, for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) post prior therapy, including chimeric antigen receptor (CAR) T-cell therapy.1
Glofitamab is the first CD20×CD3 T cell-engaging bispecific antibody approved for the treatment of patients with R/R DLBCL given for a fixed time period.1 The accelerated approval from the FDA was based on results from a phase I/II study (NCT03075696) investigating glofitamab as a fixed course in 132 patients for 8.5 months. The patients in this cohort had relapsed or were refractory from prior lines of therapy, including ~30% who had received CAR T-cell therapy. Patients achieved a durable remission after fixed-duration glofitamab treatment (Table 1).1
Table 1. Primary and secondary endpoints*
Endpoint |
Patients treated with glofitamab |
---|---|
Overall response, % (95% CI) |
56 (47–65) |
Complete response, % (95% CI) |
43 (35–52) |
Median duration of response, years (95% CI) |
1.5 (11.4–NE) |
Continued to respond for ≥9 months, % (95% CI) |
68.5 (56.7–80.3) |
CI, confidence interval; NE, not estimable. |
The safety profile was also manageable; the most common adverse event reported was cytokine release syndrome in 70% of patients (52% Grade 1 and 14% Grade 2), followed by musculoskeletal pain (21%), fatigue (20%) and rash (20%).1
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