Summer Updates: More about “dara” …and ideas about what may cause myeloma

In an important paper published recently in the journal Blood, researchers from the Netherlands and Belgium correlate the response to daratumumab (dara), the anti-CD38 monoclonal antibody, to the level of CD38 expression on the myeloma cells and whether or not complement inhibitory proteins (CIPs) CD55 and CD59 emerge with treatment. A separate report in Blood from a joint Danish, Netherlands, Italian, and US team summarizes the findings of a phase I/ II study combining dara with lenalidomide + dexamethasone to show that the combination produces responses in 81% of patients versus approximately 30% with dara alone. These results led to the development of the POLLUX trial, which recently confirmed the approximately 80% response rate for the combo with 78% of patients still in remission at close to 2 years. The results of the combination of dara with bortezomib (Velcade®) and dexamethasone (the CASTOR trial) were reported at ASCO in June this year and have just been published in the New England Journal of Medicine. In this case, the response rate was 82.9% but with shorter follow-up thus far. 

The new future for myeloma patients

As the dust settles from all the activity surrounding new drug approvals and the potential for further approvals, it is time to reflect on what the future holds for myeloma patients.

Darzalex® (daratumumab): more very good news and a caution

Janssen’s Darzalex®, or daratumumab, has been granted “Breakthrough Therapy” designation by the US Food and Drug Administration for use in combination with Revlimid® (lenalidomide) and dexamethasone, and Velcade® (bortezomib) and dexamethasone, for the treatment of multiple myeloma patients who have received at least one previous therapy. The designation was based on data from the CASTOR and POLLUX trials recently presented at ASCO 2016 and EHA 2016 respectively. The prolongation of remissions achieved by combining Darzalex with either Velcade/dex or Revlimid/dex were highlighted in my Myeloma Updates 2016 presentation, as well as recent blogs, “ASCO 2016: More excitement about daratumumab (Darzalex®), and tremendous interest in value and costs” and “Preview of the Black Swan Research Initiative’s First US Cure Trial.”

Preview of the Black Swan Research Initiative’s First US Cure Trial

This week, Dr. Shaji Kumar shares the details of the upcoming US ASCENT “Cure Trial” in a video interview on IMF-TV. ASCENT stands for Aggressive Smoldering Cure Evaluating Novel Rx Transplant. This long-anticipated clinical trial, expected to launch in late Fall 2016, is based on key tenets of the IMF’s Black Swan Research Initiative® (BSRI)®:

Is MRD testing ready for “prime time”?

The answer is a definite yes and no! Yes, it is now a priority to test for minimal residual disease (MRD) in myeloma clinical trials. However, no, MRD testing is not yet recommended in routine clinical practice.  But I’m pleased to report that we are getting there.

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