Elahere (mirvetuximab soravtansine): how was the first human dose set?

Atlas/Antibody-drug conjugates/Elahere/First dose

Elahere: how was the first human dose set?

mirvetuximab soravtansine · FRα

Check my plan vs. these

First-in-human starting dose

Rationale not stated; FIH Study 0401 escalated from 0.15 mg/kg (TBW) to 7.0 mg/kg

“MIRV: Dose escalation: 0.15 mg/kg TBW to 7.0 mg/kg TBW (n = 44 Q3W; n = 25 QW)”

✓ VerifiedEMA assessment report, p. 64Source ↗

NOAEL / key findings

10-week monkey NOAEL 4 mg/kg q3w (Cmax margin ~1); single-dose HNSTD 10 mg/kg, NOAEL 3 mg/kg; cornea, skin, bone marrow

“In a 10-week toxicity study in monkeys a mid-dose of 4 mg/kg/dose Q3W of MIRV was selected to characterize potential toxicity at an exposure metric which was predicted to be similar to that of the IV dose (6 mg/kg, AIBW) utilized for the registrational studies. This dose was considered as NOAEL.”

✓ VerifiedEMA assessment report, p. 56Source ↗