Home Forums Melanoma Diagnosis: Stage IV Accessing anti-PD1 therapy in europe

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  • #22122
    europe.md
    Participant

    Hello,

    I’ve been advised to ask here .. I’m a GP in France, so as you guess I can’t even prescribe an oncology treatment, but I often have patients who tell me about their disease , and recently a friend about her melanoma , stage IV…

    I would like to access for compationate use , out of clinical trial , an anti-PD1 medication. I can take the responsability (well, I don’t know if a simple GP prescription is really considered..) , I trust this person and she is aware of her situation

    Someone of her family is ready to travel anywhere to get the treatment … I just need the tips

    Any help welcome

    ps : a little time ago I went with the same issue to get an immunotherapy for a NSCLC … I had no idea on how to proceed .. now it’s too late šŸ˜„

    #65066
    JBunyan
    Participant

    Europe.md. Bonjour! I am a Metastatic Melanoma Grade 1V M(c) patient in UK. First diagnosed 2008 – metastases found in 2012. One – just sub cutaneous was treated by surgery followed by 6 weeks of electron radiotherapy. Later others were found in aorta area and 2 small ones in brain (treated by Gamma Knife Dec 2013).

    In the UK the National Health (Government “free” NHS) has an advisory body :NICE that gives guidance on treatments – bearing in mind cost, efficacy, etc. As I understand it the most advanced approved treatment allowed under the NHS in UK is 4 doses of Ipilimumab , and that only when other treatments have failed or the disease is multi focal.( It is certainly not used as a precautionary treatment with no metastases present). A number of drug company funded schemes are trialling PD1. A leading Consultant in UK is Dr J Larkin of the Royal Marsden, London, see . http://www.melanomauk.org.uk/medical-advisors/dr-james-larkin/ . I was sent to see him but due to my having had a TCC in a kidney a year before I was ineligible for his trial (I suspect drug companies only want “pure” melanoma candidates so as not to mar their results!). My own consultant (A Professor of Oncology in Southampton) then put me on the 4 dose course of Ipilimumab , which I completed in Jan 2014 and, so far , my latest CT scan says I am in total remission. It is hoped that PD1 (maybe in combination) will be approved in the UK NHS soon. I suggest you contact Dr Larkin or a member of his team, and he will no doubt give you the latest UK official situation. PS if you have any knowledge of French rules re driving _see my thread- I would be grateful!

    #65067
    Catherine Poole
    Keymaster

    For the expanded access of the PD1 agents, you will need to contact the respective pharmas, BMS and Merck. They do not have a public list for me to access. I would suggest the top institute in Paris is IGR: http://www.esmo.org/Patients/Designated-Centres-of-Integrated-Oncology-and-Palliative-Care/Gustave-Roussy-Institute-of-Oncology-France

    They will have information I am sure about the expanded access program. I will do some digging though and see what other contacts I can find.

    Also go to: http://www.clinicaltrials.gov and do a search for these programs.

    #65068
    tabitha
    Participant

    Hi

    The Expanded Access use of PD1 is available through the Christie Hospital in Manchester. Hope this helps.

    #65069
    Catherine Poole
    Keymaster

    I am unable to get any type of global list because of legal issues in certain countries. A doctor must reach out to the leading centers and ask about the EAP. Try our global list: http://melanomainternational.org/web-resources/global-resources/#.U9uTWfldVSQ for contacts

    #65070
    europe.md
    Participant

    thnak you all for your kind answers. I’m going to try these contacts .. will keep you updated, I think this is not done soon :(

    #65071
    Catherine Poole
    Keymaster

    Please do and I will keep asking, but it seems you will have to contact Merck or Bristol Myers Squibb in each location to get the sites list. I know Germany has it going for certain:

    University Hospital Essen

    Center for Cancer Research

    HufelandstraƟe 55

    45122 Essen, Germany

    +49 201 7232430

    http://www.uk-essen.de

    They may be able to direct you to more sources.

    #65072
    bettin
    Participant

    Dear Europe.md,

    the Merck PD1 EAP is open in Europe, however only for Melanoma patients who have progressed on Ipi first and with a very limited number of places.

    Oncologists need to apply to MSD (that’s the US Merck) on behalf of their patients and let’s put it that way *their interface is not as half as good as the PR they make about their EAP’.

    Personally- chapeau- our GP at the time hadn’t even heard about BRAF inhibitors, so your patients can be lucky to have a family doctor who cares so much. However, I think that patients with advanced Melanoma should be seen in a specialised center (like the IGR mentioned) as all these drugs are very new, immune therapies can have severe side effects requiring intensive care and also, the overall care in Melanoma with continuous monitoring and intermittent interventions such as Gamma Knife to treat brain mets or local surgery has changed dramatically over the last very few years and can no longer be done in ambulant care- as the previous palliative approach was where there wasn’t much one could do for those patientsā€¦.

    From my point of view, a good strategy for the patient would therefore be to be seen in a Melanoma centre offering the latest standard of care while being followed at home by a family doctor who has an established and more personal connection with the patient and the family.

    Best wishes,

    Bettina

    #65073
    europe.md
    Participant

    thank you for these answers…

    Bettin , as you may guess as GP we are not very aware of the last developments especialy in immunotherapy, that’s so far from our family medicine

    But of course the first advice I gave her after a few readings was to start on Ipilimumab, that seemed so obvious I think that she really should accept this in spite of the risks of advert events …that scared her so much that she refused

    #65074
    bettin
    Participant

    Good evening,

    I would refer the patient to a Melanoma centre as quickly as possible- IGR in Paris with Caroline Robert is great, otherwise you can also contact me directly- Catherine has my details.

    BRAF inhibitors could be an option, too, depending on whether or not the patient is BRAF positive; in any case, such a patient should be seen in a Melanoma centre as the side effects of immune therapies can be severe and require specialised management. Also, there are better antibodies than Ipi around and those will only be available via clinical trials or expand access programs.

    Best wishes,

    Bettina

    #65075
    rick1981
    Participant

    Hello,

    Our doctor said that on August 7th, 5 centers in Belgium have received the news they can use Pembro as part of Compassionate Use. Hope that helps!

    #65076
    Catherine Poole
    Keymaster

    I would guess they are requiring prior use of Yervoy? Can you ask your doctor what the requirements are? In the U.S. you must also have BRAF therapy if positive. Thanks for posting!

    #65077
    rick1981
    Participant

    You definitely need prior Yervoy/Ipi (minimum of 2 treatments) and since we’re already taking the BRAF ones we didn’t ask about that, but will check next time!

    We’re now debating whether we do Ipi and then Pembro in Europe (Brussels) or go to the US for Ipi plus Nivo in the USA. The latter will be more expensive (though the medicines will be free) and tough because we just have a baby girl.

    The way I look at it:

    Ipi followed by Pembro: will delay start of PD-1 by at least 6 weeks (2 treatments of Ipi) and after you fail Ipi (which 90% do) then the chance of success on Pembro drops from 40% to 28%.

    http://www.ascopost.com/issues/july-10,-2014/impressive-outcomes-achieved-with-pembrolizumab-in-advanced-melanoma.aspx

    Ipi plus Nivo: start right away and response rate of 42%.

    http://www.ascopost.com/issues/july-10,-2014/concurrent-immunotherapy-pays-off-in-advanced-melanoma.aspx

    So that seems to point to Ipi plus Nivo. What’s your view? And what about side effects?

    #65078
    Catherine Poole
    Keymaster

    Here’s what I gather from the data we’ve seen so far: For Pembro: 34% of patients responded, including 40% of the 190 patients not previously treated with ipilimumab and 28% of the 221 patients whose disease had progressed on prior yervoy. So that means the prior IPI patients had a reduction in response to Pembro of 12%. And 20-40% of patients do have good responses to IPI/Yervoy, not 10%.

    The combo of Nivo/Yervoy, though high at 42% was in a small study. The data is quite in on that until a larger study is completed. The side effects of Nivo/Yervoy are pretty pronounced and immediate I’m told. I’ve asked my scientific board for their thoughts.

    #65079
    rick1981
    Participant

    Catherine Poole wrote:

    Here’s what I gather from the data we’ve seen so far: For Pembro: 34% of patients responded, including 40% of the 190 patients not previously treated with ipilimumab and 28% of the 221 patients whose disease had progressed on prior yervoy. So that means the prior IPI patients had a reduction in response to Pembro of 12%. And 20-40% of patients do have good responses to IPI/Yervoy, not 10%.

    The combo of Nivo/Yervoy, though high at 42% was in a small study. The data is quite in on that until a larger study is completed. The side effects of Nivo/Yervoy are pretty pronounced and immediate I’m told. I’ve asked my scientific board for their thoughts.


    Ah, 20-40% for IPI/Yervoy would be much better but I had read 10% several times before (incl. from our MD), and it also seems to suggest it here, no?

    http://www.cancer.gov/cancertopics/druginfo/fda-ipilimumab

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