Final Analysis of ELM-2 Shows Promise of Odronextamab in R/R DLBCL

Sabarish Ram Ayyappan, MD, medical director of hematologic malignancies, City of Hope Cancer Treatment Center, Atlanta, discusses findings from the final analysis of the phase 2 ELM-2 trial (NCT03888105) of odronextamab (REGN1979) in a cohort of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Findings presented at the ASH 2023 showed that among complete responders in this cohort of patients, treatment with odronextamab achieved an objective response rate (ORR) of 52%. Encouraging progression-free (PFS) and overall survival (OS) rates were also observed.

Further, these results showed that the median duration of response (DOR) was 10.2 months (95% CI, 5.0-17.9), with 12- and 24-month DOR rates of 48.1% (95% CI, 35.1%-59.9%) and 36.9% (95% CI, 24.2%-49.6%), respectively. The median duration of complete response (DOCR) was similar at 17.9 months (95% CI, 10.2-not evaluable [NE]), with 12- and 24-month DOCR rates of 61.5% (95% CI, 44.4%-74.8%) and 47.2% (95% CI, 29.7%-62.9%), respectively.

Transcription:

0:09 | The overall risk objective response rate was 51% with a complete response rate of 32% in the whole cohort at a median follow-up of 29.9 months. The responses were durable with a median duration of complete response up to 18 months. At 24 months, the complete response was maintained in 47% of the patients. The safety of the drug also was evaluated and consistent with previous reports that odronextamab is safe in patients who received them with relapsed/refractory diffuse large B-cell lymphoma. We reviewed the treatment-emergent adverse events which are about 80%, and adverse events that were noted in the study included cytokine release syndrome, pyrexia, and neutropenia.

1:02 | Looking at the cytokine release syndrome, most of the patients had grade 1 cytokine release syndrome, about 12% of patients had grade 2, and only 1 patient had grade 3 and he had ongoing pancreatitis at the time of grade 3 CRS. CRS was resolved in 2 days time with supportive measures. We also described infections that the patients who received odronextamab had during the abstract session. About 60% of patients had any sort of infection in the study, including 18% of the patients who had COVID-19 and 5 COVID deaths. Now in the context of this study being completed in the time of the COVID pandemic, and patients being really immunosuppressed, they had relapsed and refractory disease, this was noted on the study.