News from Amgen

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3/15/2014 11:05pm
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Replies: 14

POW - (3/15/2014 - 11:26pm)

This is a more detailed analysis of the T-Vec Phase III trial presented at ASCO last year. This press release says: "The results showed a 50 percent or greater reduction in tumor size in 64 percent of injected tumors. In addition, one-third of uninjected non-visceral tumors, and 15 percent of visceral tumors were also reduced by at least 50 percent."

Only 64% of the injected tumors shrank (not died, shrank) and 15% of visceral (internal organs) tumors shrank. I find these to be rather disappointing results. However, other injectable "oncolytic" formulations may well work better. 

SABKLYN - (3/15/2014 - 11:44pm)

Perhaps so.  In any case, there is great curiosity in our community regarding new therapies, so I thought I would share.  The variety of treatments emerging give us all greater hope and other avenues to explore when treatments do not provide the desired response.  Given the variation in our personal physiologogies and the variation in response to these therapies, it's encouraging to see additional potential therapeutic options explored.

POW - (3/18/2014 - 12:23am)

Sabklyn, it's always good to post articles about emerging treatments, especially articles about the results of clinical trials. I always appreciate when people post news like this. And it is certainly true that different patients respond differently to different treatments so having a lot of options is a good thing.

That being said, not all potential new treatments live up to their original promise. Two-thirds of emerging drugs fail to make it through the clinical trial process. In the case of T-VEC and other "oncolytic" treatments, the theory is that if you inject easily-accessible lesions (cutaneous, subcutaneous, lymph nodes, etc) with this genetically engineered virus, it will kill the melanoma cells and simultaneously stimulate a strong, local anti-melanoma immune response. These new anti-melanoma T-cells will then spread throughout the body finding, attacking and killing tumors everywhere. That was the theory. The fact that only 15% of the visceral tumors shrank is disappointing. The fact that the treatment did not even kill all of the injected tumors (65% of them shrank by 50%) is even more disappointing.

Yes, these results prove that the concept CAN work--some visceral tumors were attacked. Yes, perhaps the scientists can refine the system in some way as to improve the results. Yes, perhaps T-VEC can be combined with something else. And I'm sure that Amgen will be considering all of these possibilities.

But as patients and as caregivers, we are often put in the position of having to make difficult treatment decisons. Our doctors can advise us, but they often just try to give us the facts to the best of their knowledge and leave the final choice up to us. So it is important that we be able to evaluate the facts as objectively as possible for our own good. Study authors or sponsors naturally want to put a positive spin on their results so they write a headline that says, "Such-and-such a treatment is effective against melanoma". And it is true-- 15% response is effective. But is it more effective than the other treatment options you are considering? That is the important question.

Positive spin notwithstanding, not all clinical trials work out as well as people hoped they would. That is the point I was trying to make.



Bubbles - (3/16/2014 - 12:19am)

Thanks for posting, SABKLYN!!!! 

Those of us who actually have melanoma are happy to hear of anything that might help us. You never know who could respond even better.  There are plenty of the folks on this board who would be quite happy to have a "50% or greater reduction in tumor size in 64% of injected tumors" well as...."1/3 of non-injected non-viseral tumors and 15% of viseral tumors...reduced by at least 50%".  Such reduction allowed 35 melanoma surgeries to remove all residual disease in 30% of those....rendering those patients NED!!!!

Guess it's easy to look down on such results when you aren't faced with the problem.  Anyhow, I am glad to know it's out there.  Glad to know researchers are continuing to push in on a treatment in every direction.  And glad folks like you took the time to share it with the rest of us.

Thanks, Celeste


Bubbles - (3/16/2014 - 12:32am)

BY THE WAY!!!!!!!!  Just realized this drug (also known as Oncovex) is to be tested in combination with anti-PD1 (Merck's product)...trials are being planned...and it seems that they are already testing it as a combo with ipi.  I guess somebody saw a good bit of potential in the data!!!  Thanks again!  C

tschmith - (3/16/2014 - 7:09am)

This all sounds so promising to me!  I was diagnosed Stage IV (brain, lung, liver, and so on)  a year ago and am encouraged by all the new research.  I'm about to try MAGE TCR (gene transfer) at NIH.  To say I'm nervous would be an understatement, but I have high hopes for a success.  

SABKLYN - (3/16/2014 - 10:26am)

T, the last few years look more encouraging for us.  Personally, when someone shares these articles, I print them and keep them in a file at home for future reference and or to discuss with my oncologist.  I'm glad you found encouragement in it.  Hoping for a full recovery for you, Celeste, POW and the rest of our warriors

BrianP - (3/16/2014 - 11:44am)


Not to hijack this thread but can you briefly explain MAGE TCR? I am mage positive and may need to start looking for new treatment option soon.


Thanks for posting.  I don't think POW was implying that it wasn't post worthy, simply that the results may have sounded a little disappointing.  I do agree with others and think this sounds really promising in combo trials.



SABKLYN - (3/16/2014 - 12:32pm)

Thanks. And certainly no offense taken from yours truly 

SABKLYN - (3/16/2014 - 10:15am)

Thanks Celeste and totally agree.  This is by no means a solution, but could be another option or in combination with other therapies provide a lasting response. Thanks for the support!

tschmith - (3/16/2014 - 2:30pm)


      I'm participating in this trial at NIH.  I'll copy a little bit from "Why is this study being done?"  This is an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, selecting a specific type of white blood cell to grow in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.  This type of therapy is called gene transfer.  The process starts with a week of chemotherapy and ends with a little IL2 after you get your cells.  I know this isn't much information.  The study number is 14-C-0052 and the Study Title is Phase I/II Study of the Treatment of Metastic Cancer that Expresses MAGE-A3 Using Lymphodepleting Conditioning Followed by Infusion of HLA-DP0401/0402 Restricted Anti-Mage-A3 TCR Gene Engineered Lymphocytes and Aldesleukin

Hope this helps!


BrianP - (3/16/2014 - 3:21pm)

Thanks Terrie!  Sounds absolutely incredible.  I just marvel at what they are able to do these days.  I look forward to hearing your progress/success.  I'm still hoping I don't need the follow on treatment but if I do I definitely see myself visiting NIH about this trial.  Best of luck to you.

POW - (3/18/2014 - 12:43am)

Celeste, haven't you noticed that at least 50% of the members here are caregivers and not patients? Maybe even more than 50%. Many patients have enough on their plates to deal with. They certainly don't want to wallow in all things melanoma by doing Internet searches, trying to find clinical trials, or reading and posting on forums. Taking on that responsibility is often one way the caregiver can help and support the patient.

I'm sick to death of you saying that if someone does not actually have melanoma you are not interested in their opinion (e.g., your statement about "Those of us who actually have melanoma..."). If the only people allowed to post here are the melanoma patients themselves, then this will be a much poorer and less helpful forum for all concerned. 

 If your intention is to attack me, personally, for some reason go right ahead. But have the guts to be honest about it. Say, "POW, keep your mouth shut!". Don't say that only melanoma patients themselves have a right to contribute their knowledge, experience and advice to this forum. And the same goes for all the "Anonymous" posters who do the same thing (and, yes, I can find your names, too). If you have a problem with something I say, feel free to call me on it. But don't use such a broad brush that you give caregivers in general get the impression that their contributions are not welcome.

MoCedar - (3/18/2014 - 9:02am)

I am not sure why some post seem to be hijacked with attacks against caregivers but it has to stop. Patients and caregivers come here for knowledge and support not claws and barbs. Some of our loved ones who "actually have melanoma" are not well enough to make life saving decisions and as caregivers we have to do the research and form a game plan. To insinuate that one must actually have melanoma to contribute to the discussion is insulting.  I am so happy that many patients are able to define their own treatment map but please do not lose sight that it is not always possible for many patients. To suggest that those of us who fight this beast with them every single day may be making bad choices because we don't actually have melanoma is cruel and insensitive. 

This discussion should be started on a new dedicated thread so those who come to MPIP for time sensitive information and support are not confused by the senseless nonsense. Just my thoughts.