Home Forums Melanoma Diagnosis: Stage IV Everything you want to know about the expanded access of PD1

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  • #63877
    Catherine Poole
    Keymaster

    I’m sorry to hear all that is going on for you and your husband. It sounds overwhelming and confusing and that’s the way things become sometimes. I thing the doctor you trust most, needs to sit down for a lengthy consultation of what is going on and what is best at this juncture. The PD1 is a promising drug but won’t necessary help the brain situation. That needs to stabilize first. Quality of life is an issue too to discuss. You need a team to help you on site, perhaps a social worker too? Or family member or friend to talk to about what is going on. I hope things improve for your husband and that you can find the support you need. let us know..

    #63878
    njreaders
    Participant

    thanks so much. I am confused why the brain issues would have to be stabilized first.

    #63879
    Catherine Poole
    Keymaster

    The only way to stabilize brain mets normally is with radiation not therapies like the PD1. They are relaxing the rules a little I’ve heard on the EAP, but here is what Philly Red who helps develop these protocals explained: “Thanks for adding to the discussion, Violeta – as you posted – “treated and stable” – these are key factors, that suggest the brain mets are not currently progressing – that can enable such patients to safely have access to the investigational drug, outside of the clinical trial. Because the pivotal Phase III safety data, which will heavily assist the FDA in determining whether to grant the anticipated approval for the drug to be marketed are not yet mature (they are still being accumulated and have not yet fully formally been evalauted by the FDA), cautions must still be maintained in treating patients with the investigational drug (even thoughthe EAP is technically not a Phase I or II study). Once the pivotal safety data are fully collected and evaluated and the toxicity profile is satisfactorily determined, it is likely that eligibility restrictions will be relaxed for the majority of patients with metatstatic disease, unless specific serious toxicities in particular organ systems become apparent, in which case certain prescribing precautions will be added for the approved drug.

    I was not suggesting that specific neurotoxicities have been observed for anti-PD1 drugs (I have no knowledge of this, and assume that there is no such toxicity, given the rate of the development of this anti-PD1 drug), but I was explaining why patients with active brain mets are almost always excluded in early phase clinical trials of oncology, as a considerable safety concern. I am very happy to hear about the EAP and feel that it is desperately needed!

    I fully understand the frustration of Stage IV patients trying to get into clinical trials, but when serious adverse events arise during a trial, especially if they are unexpected or have grave consequences, unless they can be confidently attributed to the investigational agent versus the underlying disease, the FDA will require much more safety data and evaluations, which in turn, can significantly delay the approval of a cancer drug, as well expose patients to additional risks of taking the drug if the toxicity profile is not sufficiently understood.

    #63880
    njreaders
    Participant

    The system needs to be changed. The data frmo those getting a drug under an early access/compassionate care should NOT be included in the data. It contradicts the purpose of the program.

    #63881
    Celeste Morris
    Participant

    As I posted on this same thread on March 20, there are many researchers who agree with you, NJ. I supplied the articles documenting Flanigan, Sznol, et al (July 2012!!!!) stating that “exclusion of melanoma brain met patients from clinical research programs is no longer justified.” It is also a fact that BMS (anti-PD1 product, Nivolumab), allowed an arm in my very trial at Moffitt in Tampa with patients having active brain mets. To continue to tout the old company line, when researchers have moved on in 2012, is sad to say the least. These new approaches (ipi, anti-PD1, anti-PDL1) are going to require new ways to address trials, access, etc when using them. Patients can’t be removed off trials as quickly with immunotherapy as they were with old time chemo. And many ratties like myself have already put themselves in “harms way” to determine whether or not, these treatments have “grave consequences”. Advocating requires that we stand up when things need to change. Thanks for fighting for us all, NJ. Hang in there. Wishing my very best for you and your husband.

    Celeste –

    #63882
    Catherine Poole
    Keymaster

    I don’t defend the exclusion, but folks need to realize that the most effective treatment for brain mets is radiation, stereotactic radiation. There is little proof of an agent reaching through the blood-brain barrier. I understand what Philly Red said about the exclusions in the trials too. These things are not black and white but somewhere in between. Please read about patient rights in the other thread.

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