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Epcoritamab Yields High Overall and Complete Response Rates for Patients With R/R CD20+ LBCL
The use of epcoritamab, a bispecific t-cell engaging antibody, led to higher overall response (OR) and complete response (CR) rates and a manageable safety profile among patients with relapsed/refractory (R/R) CD20+ large b-cell lymphoma (LBCL), according to findings of a phase 1/2 dose escalation study recently published in the Journal of Clinical Oncology.
Dr Catherine Thieblemont, MD, PhD, Hôpital Saint-Louis, Paris, France, and coauthors stated that although there have been major advancements in the treatment of R/R CD20+ large b-cell lymphoma, “consistency of bioengineering, manufacturing timelines, and access are limited globally. Thus, an unmet medical need still remains for effective, well-tolerated, and convenient therapies.” Researchers aimed to reach the primary endpoint of OR rate, as well as secondary endpoints including duration of response, CR, safety, and pharmacokinetics.
157 patients with a median age of 64 years, a median of 3 prior lines of therapy, and a documented CD20+ mature B-cell neoplasm were enrolled in this study. Patients were administered subcutaneous epcoritamab as a 1ml injection in 28-day cycles, with step-up doses once per week during weeks 1 to 3 of cycle 1, and full doses once per week through cycle 3, once every 2 weeks during cycles 4 to 9, and once every 4 weeks during cycle 10 and forward. Treatment was to continue until disease progression or observable toxicity.
At a median follow-up of 10.7 weeks, the OR rate was 63.1% (95% confidence interval [CI]) and the CR rate was 38.9% (95% CI). The median duration of response rate was 12 months, with the duration of response not being reached among complete responders. OR and CR rates were comparable across subgroups.
The most common treatment-emergent adverse events to occur among patients were cytokine release syndrome (49.7%), pyrexia (23.6%), and fatigue (22.9%). Immune effector cell-associated neurotoxicity syndrome was observed in 6.4% of patients, with one fatal event occurring.
In conclusion, epcoritamab showed promising results in efficacy and safety among patients with R/R large b-cell lymphoma, including those with prior CAR T-cell exposure. As primary and secondary endpoints were met, Dr Thieblemont et al concluded, “Results support ongoing and future clinical trials of epcoritamab both as monotherapy and in combination in late and earlier lines of treatment for B-cell non-Hodgkin lymphoma.”
Journal of Clinical Oncology editor-in-chief, Dr Jonathan W. Friedberg, MD, added “Future studies need to evaluate feasibility of limited duration therapy, explore rational combinations, and incorporate this agent into earlier lines of treatment.”
Source:
Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific t-cell–engaging antibody, in relapsed or refractory large b-cell lymphoma: dose expansion in a phase I/II trial. J Clin Oncol. Published online December 22, 2022. doi:https://doi.org/10.1200/jco.22.01725