Results From Pooled Phase 1 Trials

The MTD/RP2D was ezabenlimab 240 mg Q3W

From a total of 111 patients who received treatment, 107 (96%) experienced AEs, the most common of which were fatigue (39%), nausea (29%), anemia (22%), and decreased appetite (20%)

64 patients (58%) had TRAEs, and grade 3 TRAEs were reported in 7 patients (6%) [decreased appetite; arthralgia; rash; AST increased; weight increased; allergic dermatitis and rash; stomatitis and diarrhea, (n=1 each)]

Serious AEs were reported in 38 patients (34%), 2 of which were treatment-related (grade 2 pyrexia and grade 3 rash)

Immune-related AEs were observed in 33 patients (30%); most commonly hypothyroidism (7 patients [6%]). Five patients (5%) had grade 3 immune-related AEs

As of November 2020 cutoff, 98 (88%) patients discontinued treatment, most commonly due to PD (70%)

DOR ranged from 43 to 570 days