The major article today in the New England Journal of Medicine is a report  of a study with lead author, Dr. Henk Lokhorst (from VU University Medical center in Amsterdam, Netherlands) which summarizes the phase I – II trials results in 72 patients treated with daratumumab, anti-CD38 therapy.

The report has generated considerable excitement, with daratumumab being described in the media as a “blockbuster” with a high likelihood for early approval by the US Food & Drug Administration (FDA), which has already given daratumumab “breakthrough” status. The reason for this intensified enthusiasm is that the response rate is now 36% in patients receiving the 16mg/kg dose (higher versus 8 mg/kg dose) with 65% of responders still in remission after one year. This compares very favorably with, for example, carfilzomib (Kyprolis®) results at the time of approval, which had a response rate (overall response rate [ORR] or ≥ 50% improvement) of 23% and an average remission of 7.8 months. Also of note were two patients with complete remissions (CR) and two patients with very good partial remissions (VGPR), despite significant prior therapy.

The response rate was 23% in very heavily pre-treated patients and 56% for patients who had received up to three prior therapies. Toxicities, which have been an issue for recent new agents evaluated by the FDA, were very acceptable. Reactions related to the infusion of this monoclonal antibody were mostly lower grade (1 and 2). The infusions do take a minimum of 3 or 4 hours. After the first (very careful) infusions, the average infusion time was 3.3 hours.

The impressive results bode well for early FDA approval, which is fantastic news for myeloma patients. Although daratumumab is currently available in trials and a recently started “access program,” true access will occur with full commercial approval. The date of potential approval is the focus of much speculation, but will most likely be in the next 2-4 months.

So stay tuned for updates about this very good news!

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Comments

Should I go to MD Anderson if shortly have gotten out of remission after a 2nd Auto transplant. Both transplants didn't last a year, had last one on Jan. 30. My IGG and Lambda light chains are above the normal range. I was on Kyprolis ans Pomalist and was doing good, Then my oncologist took me off Pomalist due to platelets going down. But two months later I'm out of remission.
I have made an appointment at MD Anderson and will have to continue treatment with Dr.Weber. But would like to start seeing Dr. Orlasque for a second opinion.
I would like to know if daratumumab.

[personal questions will be answered offline by the IMF Infoline team.]

Hello I am newly diagnosed patient - Mgus / High Risk - 4.14 chromotrans. and 13 missing.
Will it help me to wait and take: Daratumumab (Anti-cd38). Or go to Revlimid/daxa..treatment???
I may be able to send in all the reports of the Blood/plasma results and Biopsy. If required.
DOB - 05th. Oct. 1956. Good health no 'CRAB'

[personal questions will be answered offline by the IMF Infoline team.]

It is good to see progress on this medication and we hope that it is more successful and effective at treating diseases. If it does then this will be great news for patients who are in need of such medication.

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