Saad Z. Usmani, MD
Several key trials examining daratumumab (Darzalex) in multiple myeloma were presented late last year at the 2016 ASH Annual Meeting.
, Saad Z. Usmani, MD, department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute/Carolinas HealthCare System, who presented the POLLUX update and PAVO findings at ASH, discussed the latest developments with daratumumab.
OncLive: What is the significance of the CASTOR and POLLUX trial results for patients with multiple myeloma?
: The CASTOR and POLLUX trials are perhaps 2 of the most exciting trials that have been reported out this year. As we already know, as a result of those 2 studies, daratumumab is now approved for every line of therapy within the relapsed myeloma setting.
Looking at the efficacy data and trying to look at subgroup analyses, it appears that in patients who had earlier relapses and/or had higher cytogenetics, daratumumab plus lenalidomide/dexamethasone has a superior depth of response, as well as PFS compared with the control arm on either of the studies.
What role do you think these findings will play in the landscape going forward?
Now that daratumumab is approved for earlier lines of therapy, both of those studies will be impactful for practice in the United States. My feeling is that, depending on the kind of therapies the patients have received as their first-line treatment, you may be able to pair daratumumab either with lenalidomide or bortezomib. The concern here—in the grand scheme of things—is the long-term effects of daratumumab on the immune system. We haven't seen any clinically meaningful concerns there.
You presented findings at ASH of a phase I study looking at the subcutaneous infusion of daratumumab. Can you give some background?
One of the challenges of giving daratumumab, after it was FDA approved, was that the intravenous (IV) infusion takes a long time to administer—especially the first dose, which can take up to 7 or 8 hours. Once the patients get to their third or fourth weekly dose, the infusion time can be cut down to 3 or 4 hours. However, it becomes a convenience issue.
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