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Odronextamab has demonstrated efficacy in sufferers with relapsed or refractory diffuse giant B-cell lymphoma (DLBCL), in line with analysis offered on the ASH Annual Assembly 2023.
Remaining outcomes from the ELM-2 trial confirmed the “encouraging” scientific exercise of odronextamab in these closely pretreated sufferers, stated examine presenter Sabarish Ayyappan, MD, of Metropolis of Hope Most cancers Remedy Middle in Atlanta.
The part 2 trial (ClinicalTrials.gov Identifier: NCT03888105) included 127 sufferers with relapsed/refractory DLBCL.
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At baseline, the sufferers’ median age was 67 (vary, 24-88) years, and 59.8% have been males. The sufferers had obtained a median of two prior traces of remedy (vary, 2-8), and 55.1% had major refractory illness.
The sufferers obtained odronextamab with steroid prophylaxis and step-up doses of 0.7 mg, 4 mg, and 20 mg throughout cycle 1. This was adopted by 160 mg on days 1, 8, and 15 of cycles 2 to 4. After cycle 4, sufferers obtained odronextamab upkeep at 320 mg each 2 weeks till illness development or unacceptable toxicity. Sufferers who had an entire response (CR) lasting a minimum of 9 months shifted to a dosing schedule of each 4 weeks.
The median follow-up was 29.9 months. The target response price was 52.0%, and the CR price was 31.5%. The median period of response was 10.2 months, and the median period of CR was 17.9 months.
The median progression-free survival (PFS) was 4.4 months, the 12-month PFS price was 29.6%, and the 24-month PFS price was 21.1%. The median PFS was 20.4 months in sufferers who achieved a CR and 5.8 months in sufferers who had a partial response.
The median general survival (OS) was 9.2 months, the 12-month OS price was 42.9%, and the 24-month OS price was 31.6%. The median OS was not reached in sufferers who achieved a CR and was 17.0 months in sufferers who had a partial response.
Remedy-related antagonistic occasions (TRAEs) of any grade occurred in 87.4% of sufferers, and the speed of grade 3 or greater TRAEs was 53.5%. Widespread TRAEs of any grade included cytokine launch syndrome (55.1%), pyrexia (22.8%), neutropenia (20.5%), anemia (16.5%), and infusion-related reactions (16.5%).
TRAEs led to remedy discontinuation in 9.4% of sufferers and dying in 3.9%. The causes of dying have been COVID-19 in 1 affected person, pneumonia in 1 affected person, Pneumocystis jirovecii pneumonia in 1 affected person, pseudomonal sepsis in 1 affected person, and cytomegalovirus pneumonia/cytomegalovirus reactivation in 1 affected person.
Based mostly on these outcomes, odronextamab is being investigated in earlier traces of remedy in part 3 trials, Dr Ayyappan stated.
Disclosures: This analysis was supported by Regeneron Prescribed drugs, Inc. Some examine authors declared affiliations with biotech, pharmaceutical, and/or gadget corporations. Please see the unique reference for a full listing of disclosures.
Reference
Ayyappan S, Kim WS, Kim TM, et al. Remaining evaluation of the part 2 ELM-2 examine: Odronextamab in sufferers with relapsed/refractory (R/R) diffuse giant B-cell lymphoma (DLBCL). Offered at ASH 2023. December 9-12, 2023. San Diego, CA. Summary 436.