Odronextamab has demonstrated safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL), according to results from the phase 2 ELM-2 trial presented at the 2022 ASH Annual Meeting.
Odronextamab, a bispecific antibody targeting CD20 and CD3, produced a complete response (CR) rate of 75% and was associated with mild cytokine-release syndrome (CRS).
The ELM-2 trial (ClinicalTrials.gov Identifier: NCT03888105) included 131 patients with relapsed/refractory FL. The median age of the patients was 61 (range, 22-84) years, and 53.4% were men. Patients had received a median of 3 prior lines of therapy (range, 2-13), 71% of patients were refractory to their last therapy, 74.8% were refractory to anti-CD20 therapy, 43.5% were double-refractory, and 30.5% had previously undergone an autologous stem cell transplant.
The patients were treated with odronextamab using a weekly step-up dosing protocol during the first cycle to mitigate the risk of CRS. After cycle 1, patients received odronextamab at 80 mg weekly until the end of cycle 4. After cycle 4, patients received odronextamab at 160 mg every 2 weeks until disease progression or unacceptable toxicity.
The objective response rate was 81.8%, with 75.2% of patients achieving CR. The median duration of response and the median duration of CR were both 20.5 months.
The median progression-free survival (PFS) was 20.2 months. The 12-month PFS rate was 64.0%, and the 18-month PFS rate was 55.3%.
The median overall survival (OS) was not reached. The 12-month OS rate was 86.1%, and the 18-month OS rate was 76.3%.
Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 55.7% of patients, and 7.6% of patients discontinued treatment due to TRAEs. The most common TRAEs of any grade were CRS, neutropenia, infusion-related reactions, pyrexia, and anemia.
There was 1 case of grade 3 CRS and no cases of grade 4 CRS. There was 1 case of immune effector cell-associated neurotoxicity syndrome. There were 3 treatment-related deaths, 1 each due to pneumonia, progressive multifocal leukoencephalopathy, and systemic mycosis.
On the basis of these results, phase 3 studies are planned testing odronextamab in earlier lines of treatment for FL.
Disclosures: This study was supported by Regeneron Pharmaceuticals, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Kim TM, Taszner M, Scho S-G, et al. Odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) grade 1–3a: Results from a prespecified analysis of the pivotal phase II study ELM-2. Presented at ASH 2022. December 10-13, 2022. Abstract 949.
This article originally appeared on Cancer Therapy Advisor