I am Thanos Dimopoulos from the National and Kapodistrian University of Athens in Athens, Greece, and I am the Principal Investigator of the study DREAMM-3, which is a prospective randomised trial comparing belantamab mafodotinm, or belamafm with pomalidomide dexamethasone in patients with relapsed/refractory myeloma that have received at least two prior lines of therapy.
So, in this study, 325 patients were randomised 2:1, to receive either pomalidomide dexamethasone at the standard dose, or belantamab at the dose of 2.5 mg/kg intravenously on an outpatient basis every three weeks. Treatment was given until disease progression or unacceptable toxicity. Patients were stratified according to prior lines of therapy, according to ISS, and to prior exposure to daratumumab.
The main primary endpoint was progression free survival. The median progression free survival for pomalidomide dexamethasone was seven months, and it was 11.5 months for belantamab mafodotin, but this difference did not reach statistical significance, and the hazard ratio was 1.03. Overall survival was similar between the two arms, however, duration of response was much longer for patients treated with belamaf; the median has not been reached, and for pomalidomide dexamethasone it was seven months. Response rates were similar, but patients treated with belamaf had a higher rate of very good partial response or better. Ocular toxicity was seen in patients treated with belamaf, but it was mild or moderate in the majority of the patients.
Overall, although this study did not reach the endpoint, which was a statistically significant improvement of PFS of belamaf over pomalidamide dexamethasone, it indicated that belamaf is an active agent for the treatment of myeloma inducing responses in approximately 40% of the patients, with a long-lasting duration of response.
There are further studies that are evaluating belamaf in combination with other active agents for myeloma, such as with pomalidomide and dexamethasone, or with bortezomib and dexamethasone. We are waiting for the results of these randomised studies to have a definite conclusion regarding the role of belamaf in the current landscape of myeloma treatment.