Belantamab Mafodotin Demonstrates Promising Safety and Activity for MM

Sagar Lonial, MD, Winship Cancer Institute at Emory University, Atlanta, Georgia, discusses results from the DREAMM-2 trial, which evaluated the safety and efficacy of belantamab mafodotin for patients with multiple myeloma (MM).



This is Dr. Sagar Lonial. I'm the Chief Medical Officer at the Winship Cancer Institute of Emory University in Atlanta, Georgia. I'm going to talk a little bit about the DREAMM‑2 study. DREAMM‑2 was a randomized phase 2 trial evaluating 2 different doses of bela maf, which is a BCMA‑directed antibody drug conjugate.

The goal of the study was to evaluate efficacy in a larger phase 2 expansion and also to determine which dose may be best suited for patients in the relapsed and refractory myeloma setting.

This trial was a very heavily pretreated group of patients, including a median of 5 to 6 prior lines of therapy across the board. Patients were essentially resistant to an IMiD, proteasome inhibitor, and CD38 antibody in order to be eligible to come into the trial. There was then a randomization, between 3.4 mg/kg of bela maf or 2.5 mg/kg of bela maf given on an every‑3‑week basis.

What was most striking about the early results of this trial was the fact that we demonstrated a response rate of close to 30% in both treatment arms. That suggests that certainly for patients that have refractory myeloma, with few if any other potential treatment options, that roughly a third of those patients could potentially respond to bela maf in a relapsed/refractory myeloma setting.

This is important for a couple of reasons. First, we know that available treatment options for these patients are actually quite limited. Second, for every new drug that's been approved in myeloma in a similarly heavily pretreated patient population, the overall response rate has been around 30%.

This is consistent with data we saw with daratumumab, consistent with data we saw for carfilzomib, bortezomib, and other trials that evaluated new drugs and new targets in the relapsed and refractory myeloma setting.

What we also learned was that the median progression‑free survival was about 3 months, again consistent with a 30% response rate. Almost every drug that's been approved has had a similar dataset in terms of progression‑free survival. What I think is encouraging is that the duration of response looks like it's somewhere between 6 and 9 months.

What that says to me is that among responders that the responses can in fact be quite durable. It's not a short‑lived response that we see in those patients that achieve a partial response or better.

In terms of adverse events, we did see some hematologic toxicity, remembering of course that this is a group of patients that don't have normal blood counts coming into any treatment that they are exposed to.

More importantly, we did see consistent keratopathy or ocular toxicity that we demonstrated in the early phase 1 studies as well. There were no new adverse events that were noted in this randomized phase 2 trial, suggesting that the safety profile is similar to what we had anticipated from previous trials.

When we think about conclusions or long‑term thoughts about what the DREAMM‑2 study, really means for patients and for physicians who are taking care of myeloma patients, it's really important and exciting to have new potential targets that we can use to treat patients with myeloma.

The fact that it has such robust activity in a refractory myeloma patient population suggests that this will be a very reasonable treatment option moving earlier and earlier into lines of therapy, as well as partnering with other available anti‑myeloma treatments.

In summary, we're really quite excited about having this as a potential treatment option for our patients. A new target, the only off‑the‑shelf BCMA‑targeted drug, hopefully, to be available in the next 12 months and, again, will give patients a new treatment option in the context of refractory myeloma.

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