Table 2.

Key favorable and unfavorable effects for belantamab mafodotin monotherapy in adult patients who have received at least four prior therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti‐CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy (Study 205678, cutoff date: January 31, 2020)

Effect	Short description	Treatment (n = 97)	Result	Uncertainties/strength of evidence
Favorable effects
ORR, %	Percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR, and sCR, according to the 2016 IMWG Response Criteria by IRC.	2.5 mg/kg	32	No control arm other than another dose cohort 97.5% CI: 22 to 44
DoR, median, months	Time from first documented evidence of PR or better until the earliest date of documented PD per IMWG, or death due to PD	2.5 mg/kg	11	95% CI: 4.2 to NR
Unfavorable effects a , %
Keratopathy	‐ All grades		71
	‐ Grade 3–4		31
Thrombocytopenia	‐ All grades		38
	‐ Grade 3–4		22
Anemia	‐ All grades		27
	‐ Grade 3–4		21
Lymphopenia	‐ All grades		20
	‐ Grade 3–4		17

^aTwo participants in the study DREAMM‐3 were randomized but did not receive any study treatment. These participants were excluded from the safety population.

Abbreviations: CI, confidence interval; CR, complete response; DoR, duration of response; IMWG, International Myeloma Working Group; IRC, independent review committee; NR, not reached; ORR, overall response rate; PD, progression of disease; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.