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Myeloma Research Update: Results From the STORM Trial

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Published on February 5, 2020

Key Takeaways

  • The STORM (Selinexor Treatment of Refractory Myeloma) clinical trial had 122 patients participate.
  • 40 percent of the patients in the STORM trial—refractory patients who had used all other treatment options—responded well to treatment.
  • U.S. FDA granted approval to selinexor tablets in combination with the steroid dexamethasone.

Expert Dr. Sundar Jagannath, from The Mount Sinai Medical Center, shares findings from the STORM (Selinexor Treatment of Refractory Myeloma) clinical trial, how the trial was designed and response rates for the 122 multiple myeloma patients who participated.

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Transcript | Myeloma Research Update: Results From the STORM Trial

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Cindy Chmielewski:  

Can you talk a little bit about that STORM trial and the characteristics of it?

Dr. Jagannath:            

So, I can tell you a little bit about the STORM , because we were one of the sites in which we participated in the clinical trial, and we accrued a lot of patients in this particular clinical trial. So, just going through some interesting aspect of it is in the STORM trial, 122 patients participated in the clinical trial. The median age is 65 years and ranging in age from 50 to all the way to 86, something like that. So, it is a wide range of age group participated. But in order to participate in this particular clinical trial, you should have been exposed to all the approved agents for myeloma.

Specifically, the FDA was interested in three classes of drug. The patient should’ve been exposed to the immunomodulatory drugs lenalidomide (Revlimid) and pomalidomide. They should’ve been exposed to proteasome inhibitor. Bortezomib (Velcade) and carfilzomib or Kyprolis. And they should also have been exposed to daratumumab because we now know that the patients who have been exposed to both proteasome inhibitor, both immunomodulatory molecules, and daratumumab, and the cancer is progressing, these patients have a really difficult time, and their life expectancy is limited. The patients don’t try. 

They are symptomatic, and so that is the group of patients in whom selinexor was administered. So, these patients have all seen all these five drugs, and they have shown progression individually on an IMiD medicine, on the proteasome inhibitors, so either they should’ve progressed on Revlimid and pomalidomide. They should’ve shown progression on Velcade and carfilzomib, and they should’ve progressed on daratumumab (Darzalex). They could’ve been given in combination. Once they were progressing on therapies, these patients were enrolled on the clinical trial and given selinexor and dexamethasone, as I said, 80 milligrams of the selinexor, 20 milligram of dexamethasone twice weekly.

So, once a week, it’ll become only 40 milligram of dexamethasone, which we call it the low-dose dex (Decadron) when we do Revlimid dexamethasone, 40 milligrams weekly. And in elderly patients over 75, the dose could be further reduced because there, the dex dose would be reduced. So, this is what the patients were started on. What we were quite impressed is that this combination was able to arrest the disease. The response rate was very, very good. 

There was about 26 percent of the patients responded—more than a quarter of the patients responded to this drug, and if you look at the minor responses, which are important in these patient populations because even if you reduce the cancer a little bit, the patient gets symptom relief, bone pain relief—so much relief and the quality of life is improved. So, in advance of actual myeloma patients, even minor responses really make the difference, and it actually improves the life expectancy of this patient, and that’s what we saw in this particular study. 

So, if you look at the minor response too, 39 percent of the patients responded, so close to 40 percent of the patients benefitted from this drug, which we call the clinical benefit response. So, 40 percent of the patients responded to the treatment. The response typically stayed for four months or longer. I personally had patients stay on the drug for over a year on this drug, and some of the patients went into complete remission. And even for the first time, the cancer disappeared completely. When we did the minimal residual disease which we are looking at nowadays, we found that two of the patients, the cancer disappeared even by minimal residual disease criteria.

Can you imagine a patient who had responded, and the cancer had come back to all the active agents that we know of—you know Kyprolis, Velcade, Revlimid, pomalidomide (Pomalyst), daratumumab. Then comes an oral medication that is able to make the cancer disappear completely, including in a minimal residual disease test. That’s remarkable. So, that’s why I’m very, very happy that the FDA approved this drug. And the life expectancy was improved overall nine months, but actually those patients who responded, it’s beyond 15 months, almost a year and a quarter or a year-and-a-half.

So, people who responded do remarkably well on this medication, so that’s the beauty of this particular clinical trial result, and that’s what had the FDA approve this drug at this time.

Cindy Chmielewski:  

Good. So, this was a group of patients who were refractory to all the classes of drugs and really had very little options, and you’re saying that almost 40 percent of the patients had some response? 

Dr. Jagannath:            

Correct.

Cindy Chmielewski:  

That’s pretty remarkable.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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