On the basis of the DREAMM-2 study, single-agent Belantamab mafodotin ( Belamaf; Blenrep ) was approved for patients with relapsed or refractory multiple myeloma ( RRMM ) who received 4 or more prior therapies, including anti-CD38 therapy.
Researchers have investigated longer term efficacy and safety outcomes in DREAMM-2 after 13 months of follow-up among patients who received Belamaf 2.5 mg/kg.
DREAMM-2 is a phase 2, open-label, 2-arm study investigating Belamaf ( 2.5 or 3.4 mg/kg ) in patients with relapsed or refractory multiple myeloma who had disease progression after 3 or more lines of therapy and were refractory to immunomodulatory drugs and proteasome inhibitors and refractory and/or intolerant to an anti-CD38 therapy.
The primary outcome was the proportion of patients that achieved an overall response, assessed by an independent review committee.
As of January 31, 2020, 10% of patients still received Belamaf 2.5 mg/kg. Thirty-one of 97 patients ( 32%; 97.5% confidence interval [ CI ], 21.7%-43.6% ) have achieved an overall response, and 18 responders achieved a very good partial response or better.
Median estimated duration of response, overall survival, and progression-free survival were 11.0 months ( 95% CI, 4.2 months to not reached ), 13.7 months ( 95% CI, 9.9 months to not-reached ), and 2.8 months ( 95% CI, 1.6-3.6 months ), respectively.
Response and survival outcomes in patients who had high-risk cytogenetics or renal impairment were consistent with outcomes in the overall population.
Outcomes were poorer in patients with extramedullary disease.
In patients who had a clinical response and prolonged dose delays ( more than 63 days; mainly because of corneal events ), 88% maintained or deepened responses during their first prolonged dose delay.
Overall, there were no new safety signals during this follow-up.
In conclusion, extended follow-up has confirmed sustained clinical activity without new safety signals with Belamaf in this heavily pretreated patient population with relapsed or refractory multiple myeloma. ( Xagena )
Lonial S et al, Cancer 2021; Online ahead of print