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Triplets in Newly Diagnosed Multiple Myeloma: A Q&A With S. Vincent Rajkumar, MD

Sandra Kear
Published Online: 10:52 AM, Fri December 18, 2015
Can you talk about some of the recent FDA approvals that have occurred and what this means for the field?
Yes. We have had two new drug approvals in 2013: carfilzomib and pomalidomide. Earlier this year, panobinostat was approved. More exciting right now is that in 3 weeks, the FDA approved three drugs: ixazomib, daratumumab, and elotuzumab. Two of these are monoclonal antibodies: elotuzumab and daratumumb; the first monoclonal antibodies we've ever had in multiple myeloma. They target different antigens. Elotuzumab targets SLAM-F 7, daratumumab targets CD38. The third drug that was approved is ixazomib, which is the first, oral proteasome inhibitor to be approved.

I expect all three of them to have a major impact in the treatment of multiple myeloma. It's such an exciting time that it's almost unprecedented that the FDA is here at ASH, and there will be a joint FDA/ASH symposium tomorrow evening, where we will be discussing how these new drugs are going to be impacting clinical practice. We’re going to have the FDA present the rationale for why they approved the three drugs. Then Paul Richardson, MD, and myself will be discussing how these new drugs should be used in clinical practice.
What do you think, with all these new agents now available, will be the optimal sequencing? When is the best time to use them all and how?
I think this is going to be a big problem, because I think we need to be very cautious not to jump in with the latest phase II study and change practice, because sometimes that may end up giving us the wrong outcome. It's important to wait for well-designed phase III trials, except perhaps in the high-risk population, where you might need things to move a little bit quicker. It's going to be challenging to incorporate new antibodies into frontline therapy because frontline therapy is already associated with such an excellent outcome.

You are talking about 80% 3-year, 4-year survival rates, and it's going to be hard to improve on them in a short period of time. We have to look at new surrogate endpoints, and one of them that is very prominent now is MRD-[minimal residual disease-]negative state. If we can get to MRD-negative state and use it as a surrogate endpoint for better long-term outcomes, then I think we'll be able to answer these questions in a more rapid fashion. I think the key is well-designed randomized trials. Use really intelligent, smart endpoints, and then find the answers into how best to use these drugs.
There's also some pretty important data on daratumumab that was presented. Can you comment on that?
Daratumumab is the latest drug approved that's a monoclonal antibody against CD38. So far, the results have been with monotherapy primarily. In monotherapy, in the relapsed refractory setting, it works in about 30% of patients who have failed everything else. In this meeting, we have data on daratumumab combined with lenalidomide and dexamethasone into a nice triplet combination, and in the same relapsed refractory population, you are seeing a high level of response, 88% is being reported, and that is very exciting for the field.

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