Ezabenlimab (BI 754091) monotherapy in patients (pts) with advanced solid tumours
AuthorsPatel, M. R.
Johnson, M. L.
Arkenau, H. T.
Siu, L. L.
AffiliationSarah Cannon Research Institute, Nashville, TN, USA; Florida Cancer Specialists, Sarasota, FL, USA
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AbstractBackground Ezabenlimab is a PD-1-targeting monoclonal antibody. Ezabenlimab is being investigated as monotherapy and in combination with other anti-cancer agents, and has been administered to >600 pts in combination settings. Here, we report results in pts who received 240 mg ezabenlimab monotherapy every 3 weeks (q3w). Methods Data from two phase I dose escalation/expansion trials and a phase I imaging trial are presented. Dose escalation cohorts enrolled pts with any advanced solid tumours. Dose expansion included pts with: select advanced solid tumours (including NSCLC, bladder, melanoma, gastric, ovarian, triple-negative breast cancer and RCC); TMB-high tumours (excluding MSI-high); squamous cell cervical/anal/skin tumours and vaginal or vulvar squamous cell carcinoma. Prior anti-PD-1 therapy was permitted in dose escalation but not in expansion cohorts. Tumour response was evaluated as per RECIST 1.1. Safety was assessed by incidence and severity of adverse events (AEs). Results 111 pts received ezabenlimab 240 mg q3w. 83 pts (75%) were female; median age, 62 yrs. At data cut-off (Nov 2020), 13 pts remain on treatment. Best overall confirmed response is shown in the table. Duration of response ranged from 43 to 570 days (response was ongoing in 9/16 pts at data cut-off). The most common AEs (all/?G3) were fatigue (38.7%/3.6%), nausea (28.8%/0) and anaemia (21.6%/10.8%). The most common drug-related AE (all/?G3) was fatigue (18.0%/0). 33 pts (29.7%) had immune-related AEs, most commonly hypothyroidism (7 pts [6.3%]). 38 pts (34.2%) had serious AEs (2 were considered treatment-related [G2 pyrexia and G3 rash]). There were no AEs leading to death. 2 pts had AEs leading to discontinuation (G2 colitis and G3 musculoskeletal pain). Anti-drug antibodies occurred infrequently and did not affect the PK profile of ezabenlimab. Conclusions Ezabenlimab monotherapy showed anti-tumour activity similar to other checkpoint inhibitors and was well tolerated.
CitationPatel MR, Johnson ML, Winer I, Arkenau H-T, Cook N, Samou�lian V, et al. 542P Ezabenlimab (BI 754091) monotherapy in patients (pts) with advanced solid tumours. Vol. 32, Annals of Oncology. Elsevier BV; 2021. p. S606�7.
JournalAnnals of Oncology