Benralizumab for Eosinophil-Related Cutaneous Adverse Events of Anticancer Therapy: A Phase II Trial.

PURPOSE: Eosinophil-related cutaneous adverse events (ercAE) are common after systemic cancer therapies and often affect health-related quality of life (HRQoL). In this study, we investigate the efficacy and safety of benralizumab for ercAE following systemic cancer therapies.

PATIENTS AND

METHODS

This single-arm, single-center, open-label, phase II trial (NCT04552288) in patients with cancer and systemic therapy-associated ercAE was performed from September 2020 to October 2023. Benralizumab 30 mg was administered subcutaneously according to the approved dosing schedule, with 3 doses given every 4 weeks followed by 3 doses given every 8 weeks. The primary endpoint was clinical response (reduction in ercAE to Common Terminology Criteria for Adverse Events grade ≤ 1 by week 4). Secondary endpoints included HRQoL, rash body surface area (rash-BSA), eosinophil levels, and AE.

RESULTS

At baseline (N = 47), ercAE were attributed to phosphoinositide 3-kinase inhibitors in 47%, checkpoint inhibitors in 21%, tyrosine kinase inhibitors in 9%, and antibody-drug conjugates in 9%; ercAE were grade 2 and 3 in 49% and 51% of patients, respectively. Of the 42 patients evaluable for the primary endpoint, 76% of patients (n = 32/42) responded to treatment by week 4; median ercAE grade decreased from 2 to 1 (P < 0.0001). Patients exhibited improved HRQoL, reduced mean rash-BSA, and decreased peripheral eosinophils. All patients with ercAE following alpelisib (n = 18) or enfortumab vedotin (n = 4) responded by week 4 (both P < 0.05). Most AE were mild to moderate and likely unrelated to benralizumab.

CONCLUSIONS

Benralizumab demonstrated favorable efficacy and safety against grade 2/3 ercAE related to novel cancer therapies. Further investigation in larger placebo-controlled trials is warranted.