Hello Brandy:
I try to research many of these abstracts and articles. Many of them are hard to read even after you have read a lot of them. This article from 2011, I think, is on laboratory research on multiple myeloma samples from patients, and on mice. This is the type of studies they do before giving the new drug to people. Until you give it to people, you cannot be sure that the new treatment is safe.
Phase 1 trials are done very carefully and thoroughly to establish safety. Whether or not the drug appears to actually work, they call that efficacy, is often times not even looked at in Phase 1 studies, they are so focused on safety. Then there needs to be Phase 2 and Phase 3 trials to prove that the drug is an improvement over the present treatments. I will tell you that getting from pre-clinical to approved in this short of a time is like light speed in the world of clinical trials. The next drugs in the pipeline (other monoclonal antibodies and immunotherapies) are in preclinical and early stage trials right now.
Hope this helps.
Forums
Re: FDA approves Darzalex (daratumumab)
Last edited by JPC on Tue Nov 17, 2015 3:59 pm, edited 1 time in total.
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JPC - Name: JPC
Re: FDA approves Darzalex (daratumumab)
Nancy Shamanna wrote:
I also see this as one of the most important aspects of the daratumumab approval. A third, completely different mode of attack on myeloma cells is a definite step forward. This is the kind of thing that will help keep more people going until a cure or a very long-term therapy comes along.
It is really encouraging to realize that another type of pharmaceutical has been approved in the US to treat myeloma, apart from IMID's and PI's (immunomodulatory agents and proteasome inhibitors).
I also see this as one of the most important aspects of the daratumumab approval. A third, completely different mode of attack on myeloma cells is a definite step forward. This is the kind of thing that will help keep more people going until a cure or a very long-term therapy comes along.
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Mike F - Name: Mike F
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: May 18, 2012
- Age at diagnosis: 53
Re: FDA approves Darzalex (daratumumab)
Thanks JPC for the info.
There are a couple of others that are similar to daratumub that are on the horizon - MOR202 and SAR650984. They bind to different parts of the CD38 receptor, but it's not clear that it makes any difference.
There are a couple of others that are similar to daratumub that are on the horizon - MOR202 and SAR650984. They bind to different parts of the CD38 receptor, but it's not clear that it makes any difference.
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brandyjoco - Name: brandyjoco
- Who do you know with myeloma?: husband
- When were you/they diagnosed?: September 2015
- Age at diagnosis: 54
Re: FDA approves Darzalex (daratumumab)
I am grateful for any new treatments that will extend life of people with multiple myeloma (as well as other cancers). Not sure why patients need to wait for 3rd relapse before using this drug, although it is very expensive.
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LeslieBeth
Re: FDA approves Darzalex (daratumumab)
Folks might find it useful to go back and review this earlier abstract on the use of ATRA (a vitamin A derivative) to enhance the efficacy of dara.
https://ash.confex.com/ash/2014/webprogram/Paper72429.html
In a nut, ATRA can potentially encourage more myeloma cells to present more of the CD38 marker on their surfaces, thereby allowing dara to facilitate the death of more of those multiple myeloma cells. While some might think that ATRA may be free of side effects because it is vitamin derivative, it can indeed have side effects. But these side effects might be less troubling than what some folks experience with some of the other multiple myeloma drugs.
It's my understanding that the dara/ATRA combo will soon be going into phase 1 clinical trial.
https://ash.confex.com/ash/2014/webprogram/Paper72429.html
In a nut, ATRA can potentially encourage more myeloma cells to present more of the CD38 marker on their surfaces, thereby allowing dara to facilitate the death of more of those multiple myeloma cells. While some might think that ATRA may be free of side effects because it is vitamin derivative, it can indeed have side effects. But these side effects might be less troubling than what some folks experience with some of the other multiple myeloma drugs.
It's my understanding that the dara/ATRA combo will soon be going into phase 1 clinical trial.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: FDA approves Darzalex (daratumumab)
Multibilly:
Thank you very much. Outstanding research. Innovation and creativity are key to advancing science. I would imagine that since ATRA is closely related to a Vitamin, that this is something that they could figure out a little faster than the usual process. Thanks again for the interesting post. I will ask our doctor about it. Regards, JPC
Thank you very much. Outstanding research. Innovation and creativity are key to advancing science. I would imagine that since ATRA is closely related to a Vitamin, that this is something that they could figure out a little faster than the usual process. Thanks again for the interesting post. I will ask our doctor about it. Regards, JPC
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JPC - Name: JPC
Re: FDA approves Darzalex (daratumumab)
Hello Brandy:
Thank you for that additional research and pointing out the other drugs that are in the "pipeline". You raise a very interesting question. Since we have one CD 38 agent so far, will the other ones help enough to make a difference???? The good part is that these are in the pipeline for testing, and there are other drugs as well. I hope that the experience from the Dara roll out will improve the overall advancement of the medical science for this drugs and the other drugs in the pipeline. Thank you again. Regards,
Thank you for that additional research and pointing out the other drugs that are in the "pipeline". You raise a very interesting question. Since we have one CD 38 agent so far, will the other ones help enough to make a difference???? The good part is that these are in the pipeline for testing, and there are other drugs as well. I hope that the experience from the Dara roll out will improve the overall advancement of the medical science for this drugs and the other drugs in the pipeline. Thank you again. Regards,
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JPC - Name: JPC
Re: FDA approves Darzalex (daratumumab)
Hello Nancy Shamana:
I had no idea that CD stood for "Clusters of Differentiation", and the other parts of the back story. Thank you very much for posting this, and illuminating us on the research in this area. It removes some (but not all) of the mystery.
Best Regards,
I had no idea that CD stood for "Clusters of Differentiation", and the other parts of the back story. Thank you very much for posting this, and illuminating us on the research in this area. It removes some (but not all) of the mystery.
Best Regards,
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JPC - Name: JPC
Re: FDA approves Darzalex (daratumumab)
JPC,
Multibilly has explained "clusters of differentiation" really well several times here in the forum. Just as an example, see his explanation in this posting:
https://myelomabeacon.org/forum/please-help-me-defining-the-term-cd-t2618.html#p14031
Quoting from the post:
Plasma cells have various groups of antigens on their surface. These antigens are flags that help tell your immune system if the cell is a friend or foe. There are many different flags (clusters of differentiation), something like 300 different ones. Healthy plasma cells have their own unique combination of flags. Myeloma plasma cells can have some slightly different flags. One of the more common flags found in myeloma cells is CD138. The overall profile of your flags is what is called your immunophenotype.
When analyzing the cells during your test, some of these flags pop up and others don’t. When they do pop up, they are positive (i.e. CD138+). When they don’t pop up, they are negative (i.e. CD56-).
Healthy plasma cells typically have the following profiles of clusters of differentiation: CD19+, CD45+, CD20–, and CD56–.
Myeloma cells can have the following profiles of clusters of differentiation: CD56+, CD38+, CD138+, CD19-, CD45-, etc.
Multibilly has explained "clusters of differentiation" really well several times here in the forum. Just as an example, see his explanation in this posting:
https://myelomabeacon.org/forum/please-help-me-defining-the-term-cd-t2618.html#p14031
Quoting from the post:
Plasma cells have various groups of antigens on their surface. These antigens are flags that help tell your immune system if the cell is a friend or foe. There are many different flags (clusters of differentiation), something like 300 different ones. Healthy plasma cells have their own unique combination of flags. Myeloma plasma cells can have some slightly different flags. One of the more common flags found in myeloma cells is CD138. The overall profile of your flags is what is called your immunophenotype.
When analyzing the cells during your test, some of these flags pop up and others don’t. When they do pop up, they are positive (i.e. CD138+). When they don’t pop up, they are negative (i.e. CD56-).
Healthy plasma cells typically have the following profiles of clusters of differentiation: CD19+, CD45+, CD20–, and CD56–.
Myeloma cells can have the following profiles of clusters of differentiation: CD56+, CD38+, CD138+, CD19-, CD45-, etc.
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JimNY
Re: FDA approves Darzalex (daratumumab)
Thanks for the reminder about the ATRA research and daratumumab, Multibilly.
From what I can see in the abstract, it seems that ATRA probably could potentially be used to enhance the efficacy of all CD38 myeloma therapies -- SAR650984 and MOR202, as well as daratumumab. There doesn't seem to be anything that would restrict it to just helping daratumumab be more effective.
From what I can see in the abstract, it seems that ATRA probably could potentially be used to enhance the efficacy of all CD38 myeloma therapies -- SAR650984 and MOR202, as well as daratumumab. There doesn't seem to be anything that would restrict it to just helping daratumumab be more effective.
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JimNY
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