Blenrep (belantamab mafodotin): how was the first human dose set?

Rationale not stated; first-in-human DREAMM-1 escalated from 0.03 to 4.6 mg/kg Q3W (Source: FDA multi-discipline review, p. 91.)

Precedia/Antibody-drug conjugates/Blenrep/First dose

Blenrep: how was the first human dose set?

belantamab mafodotin · BCMA

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First-in-human starting dose

Rationale not stated; first-in-human DREAMM-1 escalated from 0.03 to 4.6 mg/kg Q3W

“The FTIH study DREAMM-1 evaluated dose levels from 0.03 to 4.6 mg/kg Q3W and selected 3.4 mg/kg Q3W based on emerging efficacy, safety, and pharmacokinetic data for evaluation in Part 2 of the study.”

✓ VerifiedFDA multi-discipline review (BLA 761158, 2020 accelerated approval (withdrawn 2023; approved again Oct 2025)), p. 91Source ↗

NOAEL / key findings

Monkey HNSTD 3 mg/kg; kidney (dose-limiting), liver, lung, testes, bone marrow, cornea (rat), inflammation

“The highest non-severe toxic dose in monkeys was 3 mg/kg and the highest dose tested exceeded the clinical dose by 3.8 and 2.5 -fold (ADC and mAb respectively).”

✓ VerifiedEMA assessment report (EPAR EMEA/H/C/004935/0000, 23 July 2020), p. 44Source ↗

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Blenrep: how was the first human dose set?

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