麻豆传媒

Monotherapy with and well-tolerated in patients with relapsed/refractory multiple myeloma, according to research presented at the .

In this exclusive 麻豆传媒 video, study author , director of the Judy and Bernard Briskin Center for Multiple Myeloma Research at City of Hope in Duarte, California, discusses the findings.

Following is a transcript of her remarks:

This was a poster presentation and updated results that were presented at the ASH meeting last year, now including more patients with longer followup. So TAK-079 is an anti-CD38 antibody that is unique in the sense that it has a high bioavailability for the target cell, the plasma cell, and less binding to red blood cells. So theoretically, therefore, it could cause less off target side effects, notably in terms of cytopenias.

The trial that was reported on it at ASCO was a phase Ib trial, a dose escalation starting at 45mg going up to 1,800mg as the planned maximum dose. Given in a traditional fashion, similar to other anti-CD38 antibodies weekly for two cycles. And bi-weekly cycles, three to six, and then monthly cycles seven and beyond. The update at ASCO reported on a total of 41 patients. Of note, 82% of these patients had prior STEM cell transplant. Also notable, was that 25% of them had had prior anti-CD38 antibody. And that 65% with double refractory to both an IMiD and a PAI.

In terms of safety, we saw that this drug was very well tolerated. There was no infusion reactions. Very rare, mild injection site reactions. No significant lymphopenia or thrombocytopenia. And looking at outcomes, we also saw some favorable outcomes in terms of response rates. So once we reached the target saturation dose, we saw an overall response rate of 28%. And if you look at anti-CD38 naive patients that were responsive at the 600 mg dose, which is the chosen dose moving forward, the overall response rate was 36%, which is very comparable to the response rates with single agent daratumumab in some of the early initial studies.

So the other notable fact now that this trial has been going on that we've seen durability of responses with several patients being on therapy beyond 12 months, and also response is deepening over time, including the patient developing MRD negative disease by cycle 13.

So, this trial is continuing to accrue patients and also exploring combinations with this regimen, given the very favorable hematologic toxicity profile. It's currently also understudying combination with pomalidomide.

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