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    Dear Catherine, melanoma patients and caregivers

    Found this link and it got me worried , part of the article states that:

    Merck said it plans to start late-stage clinical trials testing lambrolizumab in patients with a deadly form of skin cancer, melanoma, as well as non-small-cell lung cancer, in the third quarter. If all goes well, the company could file for regulatory approval in 2015.

    Why should such a promising medicine take so long to get on the market , this medicine could save lives including my sister’s and many others….

    As you might have experienced it is very difficult to access a trial as they have inhuman exclusion criteria s, and it’s limited for few lucky ones.

    It’s so unfair ! we must unite and make our voices heard so these medicines are on the market faster.


    Catherine Poole

    I think that this is a complex problem without easy answers. For our protection, the FDA is slow to approve drugs and sometimes due to their own complex bureaucracy drugs are delayed. I’m not sure the patients are the center of all of these efforts. The Pd1 drug has a 38% response rate, it is not a miracle drug but certainly promising. There are two main companies, Merck and BMS producing this and the competition is a good thing. The PdL drug is another promising one to look for. Trials are opening in many spots now for that and I’d keep an eye on that. I will try to get an up to date list soon. I can assure you that we as advocates keep you at the center of our activities and communicate regularly with all interested parties.



    Have you an updated status about BMS and Merck approving PD1under “compassionate use”.

    I know that you tried to help Nick Auden “Save Locky’s Dad”. I read that Nick has successfully had Brain Surgery and doing very well. I have read and seen interviews with Nick and it appears that he want PD1 and will not consider other drugs/clinical trials.

    Have you heard anything back from Nick about getting into a clinical trial. Are you helping him find another clinical trial?

    Thanks for continuing to help everyone.



    Hi James,

    Francoise found on Nick’s facebook that it looks like a) he’s mounted a campaign to get access to anti-PD1 (thusfar not successful) and b) in the “meantime” he’s preparing for doing TIL at WDAnderson, starting with IL-2….From what he says, it doesn’t sound like he realizes how rough that route is, so I hope it’s not too much of a surprise.

    I wonder, when people try to mount a campaign for compassionate (personal) use of a drug, how often that works. This is an important issue for a lot of us. I am blanking on the details right now, but I read something recently about how reluctant drug companies are to grant special access to promising drugs before they’ve gone through phase III trials successfully (one reason – if they granted access to a lot of very sick people, who would still want to go through a clinical trial to gain access?). I think it was that NYTimes piece on clinical trials a week or two ago, or am I dreaming?

    I keep being told that anti-PD1 isn’t likely to be available, either in expanded access form (right after a successful phase III trial) or actual FDA approval (some months later), until 2015, which is an excruciatingly long wait….This is a particularly pernicious example where, by all accounts, this is a very good drug (just from the early phase I and II trial results) that still is going to have to go through the laborious and very time-consuming procedures that we’d like to be waived, and would be willing to have waived for us…


    Catherine Poole

    Both producers of PD1 were very “mum” about any compassionate or expanded use. I think the publicity surrounding Nick’s appeal made it harder in some ways and he has not been back in touch. I’m sorry to hear his choice of therapy as he has meningeal disease and I can’t imagine this will help, but you never know! I agree this is a terrible thing that PD1 doesn’t go to expanded use. I feel powerless, sad to say, in trying to persuade pharma. They have their own reasons for not being forthcoming. PDL is going forth in trials, a bright spot and researchers seem happy about.


    Jonathan & Catherine,

    Thank you both for the update. I had no idea that Nick had meningeal disease. I would agree with you Catherine about IL2 & TIL. I have never heard of anyone with meningeal disease that has been treated successfully.

    As much as we all have heard that PD1 has a 38% response rate, has anyone heard that PD1 is effective in treating cancer in the brain?

    My prayers go out to Nick. At least he is not sitting around for BMS and MERCK to give him PD1 under compassionate use. I think that he would have a long wait and it might have been too late.



    Dear all

    Thanks for taking time to read and reply.

    Catherine – I know this is no magic bullet but still its very frustrating to know there is something and you cannot try it . I have been wrecking my brains day and night trying to find a way out. I wrote to both comapanies without success.

    Why dont we try to make a petition like Nick did but this time to get faster approval , or maybe to stop all this beauracracy and put the patient’s interest’s first.

    Wishing you all health and happiness



    Dear all,

    I have learned a lot in the last time from your posts and thanks to all of you for that.

    Related to anti PD1, so far I understood there are two antibody agents PD1 , one is lambrolizumab produced by Merck which is reported for a response rate of 38% and the other one Nivolumab produced by BMS , with a response rate in patients of 31%. Indeed not miracles, but for all of us an hope in treating melanoma. So is good to be aware of these difference when you have the chance to go for a trial. I think is very important to know also the concentration of the drug that they used in a clinical trial , because different concentrations are giving different response rates. I hope these info are right if not please correct me.

    About anti-PD1 (both of them) treating the brain tumor I heard nothing indeed, is a good question. I know that amongst immunological treatments, Yervoy showed some potential in treating brain tumors (this I have heard from the doctor of my sister), I also hope is a reliable info..

    But related to the topic of this post: looks like lambrolizumab (Merck product) will be approved in 2015, but what about Nivolumab (BMS product)? ..


    Hello Violetta

    Do you mean that your sister’s oncologist said that anti pd1 does not work on brain mets?

    Yes from what I read Yervoy does work for some patients with brain mets , and my sister has not yet tried it.

    Thursday 21st she has an appointment with professor Gore so he will tell us which is the best way forward, We will prepare a set of written question to ask him.

    It’s so hard going all through this , she is just 28 years old and it breaks my hearth to see her suffer and being able to do nothing.

    Regarding the BMS anti pd1 approval I guess it will take longer than the Mercks since Mk3475 was given break through medicine last April and such status helps to make things go fatser. Correct me if I am wrong Catherine.

    It’s always a pleasure to share my thoughts with people in the same boat.

    Violetta I hope all goes well for your sister and she lives a healthy long life

    God bless you all



    Hi All,

    I came across Merck 3475 phase 2 clinical trial ‘Study of MK-3475 Versus Chemotherapy in Participants With Advanced Melanoma” which states:


    “This study is ongoing, but not recruiting participants.”

    This study has 510 enrollment seats.

    Catherine, do you know why Merck is not recruiting for this study?? Is it full??? This is an important study for Merck & the FDA approval process. Do you know where the locations sites are?



    Thanks Maggie. I am so sorry about your sister. She is so young..

    Lets hope in better times for all of us.

    No, the doctor of my sister said nothing about anti-PD1 working or not on brain tumors. In Romania not a lot is known about these experimental therapies. Now, thinking better, at the european cancer conference held in Amsterdam (28 sept 2013) they did not particularly discuss the effect of anti-PD1 on tumor brains. If somebody knows different, please let us know.

    Yervoy and zelboraf are the most recommended treatments in Romania, besides dacarbazine and radiotehaphy. First two are not covered by the insurance provider, so ..is quite a bad situation.

    We are counting now the days until my sister will go to the last evaluation before entering in anti-Pd1 clinical trial. If they will find another brain tumor or that the old one is unstable she will not enter in it. Another bad scenario is if she she falls in dacarbazina arm..:-( Lets hope she will be lucky.

    I wish a lot of luck to everybody here.


    My understanding is that the IPI antibody itself does not penetrate the blood-brain barrier. However, the cancer killing activated T-cells that IPI helps your system to produce can and do, cross that barrier.

    Not sure about the PD-1 stuff. However, the combination of IPI and PD-1 is getting a lot of attention as early data from a BMS trial suggested that the response rate of that combination (at 3mg doses for each) is close to the addition of the IPI and PD-1 individual response rates, or ~50+ percent. A response was defined as a 50% or more reduction in tumor count/size. The Overall Response Rate (ORR), which, I believe, is defined to include tumor reductions lower than 50% and/or “stable” disease, was not quoted but may well be higher. Let’s pray the early combination data holds up (and gets even better!)as the trial accumulates time and patients.

    There is much hope here were there was little before. Which is certainly something to be thankful for as we approach Thanksgiving Day here in the US. Personnaly I think Thanksgiving should be a world wide celebration.

    Violeta, Maggie, I’m so sorry your sisters (and you!) have to deal with this crappy disease, but there is well grounded hope. Also drop in at the caregivers forum. It’s a great outlet for caregivers as we also suffer very real side effects and symptoms from this disease.


    Celeste Morris

    To all….specifically related to the question of anti-PD1 activity in the brain….

    I completed 2 1/2 years of BMS anti-PD1 therapy (Nivolumab) at Moffitt in June 2013, after a primary and second primary melanoma skin lesion, lung met, brain met, and tonsilar met, but remain NED today….more than 10 years post initial lesion and 4 years post Stage IV disease. My entire story is on my blog….just google “chaotically precise.” Information I was given from Moffitt and Dr. Weber regarding anti-PD1 and brain mets are on posts made on September 16, 2013 and June 11, 2013.

    Yours, Celeste


    I was chasing MERK s anti pd 1 round EU . Nobody really wanted a Brit with ocular melanoma. Got close to getting into Norway then they just closed the trial saying I couldnt have got there in time it was 3 days i could have but they did not want a non national etc. All left unsaid. Merk then told me it will not go to compassionate use till 2016 as they have manufacturing problems and only have enough drug for those currently on trials.

    Dont know if its made from Russian Hamster’s ovaries like Ipi but theres a problem in supply which is why they are not trying to expand.

    No idea whether I was told the truth or just a fobbing off.


    Violetta your sister will be in my prayers. Good luck.

    Thanks Celeste for your positive feed back – there is hope for some.

    Hello Lak I am so sorry for you and at the same time angry at these pharma companies that treat patients like shit ( sorry for the expression ) I hope you manage to find a suitable solution

    My sister is being treated at the Royal Marsden London and since we are not British they told her she is not eligible for trial of anti PD1 . She has not yet tried Yervoy and the Braf – Mek combo so we still have options. Still not being able to access Anti pdi is very frustrating. Next Thursday we have an appointment with her oncologist to see what follow up treatment will they give her.

    wishing you a long healthy and happy life


Viewing 15 posts - 1 through 15 (of 19 total)
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