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1558P Mitigating infusion-related reactions (IRRs) with cetirizine and montelukast in patients (pts) receiving REGN7075, an EGFR×CD28 bispecific antibody (bsAb)
Abstract   Peer reviewed

1558P Mitigating infusion-related reactions (IRRs) with cetirizine and montelukast in patients (pts) receiving REGN7075, an EGFR×CD28 bispecific antibody (bsAb)

N.H. Segal, E. Girda, B.P. Keenan, J.R. Hecht, X. Le, M.L. Johnson, J. Torres Jimenez, C.A. Gomez-Roca, F. Ghiringhelli, O. Ates, …
Annals of oncology, Vol.36(Suppl 2), pp.S930-S930
09/2025
DOI: 10.1016/j.annonc.2025.08.2188

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Abstract

Background REGN7075, a first-in-class costimulatory bsAb, is designed to bridge CD28+ T cells with EGFR-expressing tumour cells, facilitating T-cell activation through endogenous tumour antigens. An ongoing first-in-human, open label, phase 1/2 study (NCT04626635) is evaluating REGN7075 ± cemiplimab (anti–programmed cell death-1) in pts with advanced solid tumours. IRRs are the most common AEs, mostly occurring during the initial two infusions; hypotension is a common IRR symptom. Cetirizine, a second generation, H1 antihistamine, and montelukast, a leukotriene receptor antagonist approved to treat asthma and allergic rhinitis, target distinct inflammatory pathways. Cetirizine and montelukast (CM) were added to standard premedication (SP) to reduce REGN7075-associated IRRs by modulating inflammatory response. Methods During dose escalation, oral CM was added to SP (including acetaminophen, diphenhydramine, an H2 antagonist, normal saline bolus and a corticosteroid). Pts who received ≥2 doses of REGN7075 received CM 10 mg daily, 2 days before (W1 D–2) the first infusion day (W1 D1) through to the day of the second infusion (W2 D8). After initial safety and efficacy establishment, this regimen was integrated into the SP protocol. Primary outcome: incidence of IRRs. Results This analysis included 134 pts; 83 received SP and 51 received SP + CM. In the SP cohort, 67 (81%) pts experienced an IRR during treatment versus 26 (51%) in the CM cohort. Grade ≥2 IRRs occurred in 61 (73%) pts in the SP cohort versus 10 (20%) pts in the SP + CM cohort. Of 122 IRRs experienced by pts in the SP cohort, 26% (n=32) were Grade 1, 73% (n=89) were Grade 2 and 1% (n=1) were Grade 3. Of the 31 IRRs experienced by pts in the SP + CM cohort, 65% (n=20) were Grade 1, 35% (n=11) were Grade 2 and there were no Grade ≥3 events. Hypotension as a symptom of IRRs occurred in 36% of pts in the SP cohort versus 6% in the SP + CM cohort. Conclusions The addition of CM prior to the first two doses of REGN7075 led to a reduction in the incidence and severity of IRRs.

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