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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 August 26, 2024, it was announced that the European Commission (EC) has approved odronextamab, a CD20xCD3 bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who progress after ≥2 lines of systemic therapy, including a chimeric antigen receptor (CAR) T-cell therapy. This announcement is based on key results from the ELM-1 (NCT02290951) and ELM-2 (NCT03888105) clinical trials, where odronextamab demonstrated robust, durable response rates and an acceptable safety profile in adults with R/R FL or R/R DLBCL. Odronextamab previously received a positive CHMP opinion from the European Medicines Agency for the treatment of patients with R/R FL and R/R DLBCL.
ELM-1 is an ongoing multicenter, open-label, phase I trial investigating the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies who have undergone prior treatment with CD20-directed antibody therapy, including a cohort of patients who have progressed following CAR T-cell therapy.
ELM-2 is an ongoing, open-label, multicenter, pivotal phase II trial investigating the efficacy of odronextamab in adult patients with B-cell non-Hodgkin's lymphoma (B-NHL). The primary endpoint is ORR according to the Lugano Classification, as assessed by an independent review committee (IRC), and secondary endpoints include CR, progression-free survival, overall survival, and DoR.
The most common adverse reactions were cytokine release syndrome (54%), neutropenia (41%), pyrexia (39%), anemia (38%), thrombocytopenia (27%), diarrhea (24%), and COVID-19 (22%).
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