Safety
death, TEAEs, Treatment-emergent adverse, corneal events, deaths
EVENTS, ADVERSE EVENT, DISEASE PROGRESSION, PERIPHERAL SENSORY NEUROPATHY
All patients in cohorts Q2W-LD and Q3W experienced ≥1 TEAE (Treatment-emergent adverse events in cohorts Q2W-LD and Q3W (all-treated/safety population)Abbreviations: C1, cycle 1; Q2W, every 2 weeks; Q2W-LD, cohort receiving a loading dose at day 1, cycle 1, followed by a fixed dose every 2 weeks; Q3W, cohort receiving tusamitamab ravtansine every 3 weeks; Q3W, every 3 weeks; TEAE, treatment-emergent adverse event.
Two patients in cohort Q2W-LD and 1 patient in cohort Q3W discontinued treatment because of TEAEs (Corneal events were a prominent TEAE in patients in both cohorts. In cohort Q2W-LD, 9 of 28 (32.1%) patients experienced corneal events, all occurring at the two highest LD-DLs (1 at 150 mg/mIn cohort Q3W, 6 of 15 (40.0%) patients experienced corneal events (1 at DL 120 mg/mIn cohorts Q2W-LD and Q3W, 4 and 3 patients, respectively, experienced grade 1 peripheral sensory neuropathy that did not require dose modifications. None of the 4 patients in cohort Q2W-LD but all 3 patients in cohort Q3W had a history of peripheral sensory neuropathy.In cohort Q2W-LD, 8 of 28 patients died during the study, and in cohort Q3W, 3 of 15 patients died. No deaths were considered to be related to treatment. Reasons for death in cohort Q2W-LD included disease progression (