Encouraging data for ELA026 to treat secondary haemophagocytic lymphohistiocytosis

The investigational drug ELA026 improved survival and yielded a manageable safety profile in participants with secondary haemophagocytic lymphohistiocytosis (HLH) in a phase 1 study, warranting further investigation of the agent.

The investigational agent ELA026 targets signal regulatory protein (SIRP)-α/β1 on myeloid cells and SIRPγ on T-lymphocytes. Dr Abhishek Maiti (MD Anderson Cancer Center, TX, USA) and colleagues tested ELA026 among patients with secondary HLH in a phase 1 study (NCT05416307) [1]. During the current presentation, Dr Maiti discussed findings from 8 treatment-naïve participants with malignancy-associated HLH exposed to ELA026. “These participants stemmed from the refined study population cohort,” said Dr Maiti. For the safety analysis, data from cohorts 1 and 2 was involved, including participants with refractory or relapsed disease.

After 4 weeks of therapy, all 8 participants presented with at least a partial response. The observed 2-month survival rate of 88% on ELA026 was substantially higher than the 2-month survival rate from natural history malignancy-associated HLH cohorts (50%; see Figure).

Figure: Therapy response and survival upon ELA026 administration to participants with treatment-naïve malignancy-associated HLH [1]



AITL, angioimmunoblastic T-cell lymphoma; ALL, acute lymphoblastic leukaemia; CR, complete remission; DLBCL, diffuse large B-cell lymphoma; EOS, end of study; EOT, end of treatment; HI, haematologic improvement; mCR, marrow complete remission; NK cell, natural killer cell; PR, partial remission; PTCL-NOS, peripheral T-cell lymphoma not otherwise specified; R/R, relapsed/refractory; TN, treatment-naïve.

Thrombocytopenia (35%), neutropenia (24%), and infusion-related reactions (18%) were among the most commonly observed adverse events (AEs) in the 17 participants included in the safety analysis. “A third of the neutropenia and thrombocytopenia was already established at baseline,” highlighted Dr Maiti.

“ELA026 appeared well-tolerated and was associated with improved survival outcomes among treatment-naïve participants with malignancy-associated HLH,” concluded Dr Maiti. “This promising therapy may help to control the cytokine storm from any trigger that is the main driver of early mortality in patients with secondary HLH.”

1. Maiti A, et al. ELA-026 targeting of SIRP+ immune cells results in a high response rate and improved 2-month survival of treatment-naïve malignancy associated hemophagocytic lymhohistiocytosis in a phase 1 study. LB3442, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 202412 August 2024