Safety
gastrointestinal events, nausea, fatigue, diarrhea, vomiting, dermatitis acneiform, rash, fatigue/asthenia
ADVERSE EVENT
The median duration of exposure to binimetinib + panitumumab combination therapy was 9.1 (range 5.3-40.0) weeks in phase Ib and 6.1 (range 1.0-48.0) weeks in phase II of the study (Across both study phases, all patients experienced ≥1 AE, regardless of study drug relationship; the most common AEs were diarrhea (71.7%), vomiting (52.8%), nausea (50.9%), fatigue (49.1%), dermatitis acneiform (43.4%), and rash (41.5%) (AEs, regardless of study drug relationship, and select laboratory abnormalities occurring in ≥20% of patients across treatment groups.Data are Abbreviations: AE: adverse event; AESI: adverse event of special interest; CPK: creatine phosphokinase.In phase Ib, 8 patients (80.0%) reported ≥1 grade 3/4 AE, and 3 patients (30.0%) had serious AEs (SAEs; all grade 3/4). In phase II, 37 patients (86.0%) experienced grade 3/4 AEs and 22 (51.2%) had SAEs, including 17 patients (39.5%) who had grade 3/4 SAEs. Overall, the most common SAEs (>1 patient) included diarrhea (All patients experienced ≥1 AESI, most frequently dermatologic rash (90.6%), gastrointestinal events (88.7%), and fatigue/asthenia (62.3%). During phase Ib, 6 patients had a grade 3/4 AESI; in phase II, 29 patients experienced a grade 3/4 AESI.