Posted: Wednesday, May 11, 2022
According to Jennifer R. Brown, MD, PhD, of Dana-Farber Cancer Institute, Boston, and colleagues, monotherapy with the CD20-CD3 bispecific antibody odronextamab demonstrated “promising” clinical activity, a manageable safety profile, and durable responses in heavily pretreated patients with B-cell non-Hodgkin lymphoma. The results from this cohort of the multicenter phase I ELM-1 trial, which were published in The Lancet Haematology, support future phase II and III investigations.
A total of 145 patients from the United States and Germany with CD20-positive relapsed or refractory disease received intravenous odronextamab (dose-escalation: n = 94; dose-expansion: n = 51). Odronextamab was administered up to the maximum dose of 320 mg once weekly during the dose-escalation phase; no dose-limiting toxicities were observed. The recommended dose for expansion was 80 mg in patients with grade I to IIIA follicular lymphoma and 160 mg in those with diffuse large B-cell lymphoma.
The majority of cytokine-release syndrome and neurologic treatment-emergent adverse events were low grade and did not lead to treatment discontinuation, according to the study investigators. Anemia (25%), lymphopenia (19%), hypophosphatemia (19%), neutropenia (19%), and thrombocytopenia (14%) were the most frequently reported treatment-emergent adverse events of grade 3 or higher. A total of 61% of patients experienced serious treatment-emergent adverse events; the most common such events were cytokine-release syndrome (28%), pyrexia (8%), pneumonia (6%), and infusion-related reactions (4%). Four treatment-related deaths were reported.
The objective response rate was 51%. In patients with follicular lymphoma who received at least 5 mg of odronextamab, the objective response rate was 91%, and the complete response rate was 72%. The objective and complete response rates were 53% and 100%, respectively, in those with chimeric antigen receptor (CAR) T-cell therapy–naive diffuse large B-cell lymphoma who received at least 80 mg; in patients who underwent CAR T-cell therapy, the objective response rate was 33%, and the complete response rate was 27%.
Disclosure: For full disclosures of the study authors, visit thelancet.com.