What is the Goal of Multiple Myeloma Treatment?

Last week, the U.S. Food and Drug Administration (FDA) approved the use of Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

The effectiveness of the treatment combination was evaluated in the CEPHEUS open-label, randomized, active-controlled trial in patients with newly diagnosed multiple myeloma who were ineligible for ASCT or refused ASCT as initial therapy. In that study, more than 52% of trial participances achieved minimal residual disease negativity with D-VRd, and additionally the risk of progression or death was reduced by 40%.

CURE recently spoke with CEPHEUS study investigator Dr. Saad Z. Usmani, chief of the myeloma service at Memorial Sloan Kettering Cancer Center, to discuss the trial and how it fits into providers’ overall treatment goals for patients with multiple myeloma.

Transcript

What is the significance of this FDA approval?

For years, the 'triplet' regimen was the gold standard for newly diagnosed patients who weren't candidates for a stem cell transplant. Could you explain why adding a fourth drug in the CEPHEUS trial represents such a significant leap forward in efficacy?

I want to share the overarching goal for myeloma treatment: It's to get patients into as good and deep of a response as possible, especially in that first year of diagnosis, and then maintain that response moving forward. And that's what we've learned over the past 15 years gets patients to the best survival outcomes and also helps alleviate the symptoms and sequela of the disease. So, you know, for patients who may be suffering from fatigue or kidney problems or bone issues, all of those things get better as you control the disease.

And the goal here [in this clinical trial] is exactly that: Can we add an anti-CD38 monoclonal antibody to the triplet combination of [Velcade], [Revlimid] and dexamethasone and get those deeper responses, that eventually we're going to help our patients living longer and stay in remission for longer?

So that was the whole premise of this particular trial as well. But that's, in general, our goal. Regardless of whether we are treating young patients or old patients, patients who will be eligible for transplant or not, we want all our patients to get to the deepest responses possible during that first year.

Reference:

1. “FDA Approves Darzalex Faspro-VRd For Newly Diagnosed, Transplant Ineligible Multiple Myeloma,” CURE; https://www.curetoday.com/view/fda-approves-darzalex-faspro-vrd-for-newly-diagnosed-transplant-ineligible-multiple-myeloma

Transcript has been edited for clarity and conciseness.

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