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  • #22008
    Catherine Poole
    Keymaster

    I will report back to you what I hear. Lots can come out of the questions and answers/rather than press reports. It does seem that braf/mek (Gsk) works better than alone and less toxic. That was this morning from Keith Flaherty et al.

    #64593
    Catherine Poole
    Keymaster

    There should be some good news for stage 3 folks that IPI may become an adjuvant therapy proven by phase III trials. I discussed with FDA folks our predicament for NED/stage 3 folks and they very much agreed this needs to change. This will be my pet project! Nothing drastically new or exciting so far.

    #64594
    katie1
    Participant

    Abstract posted this morning on ASCO pages says, “Ipi significantly improved RFS vs Pbo.” This is from the adjuvant EORTC 18071 study of 10mg/kg vs Placebo. Catherine I hope you hear more info from the conference.

    Kate

    #64595
    Anonymous
    Guest

    Catherine Poole wrote:

    There should be some good news for stage 3 folks that IPI may become an adjuvant therapy proven by phase III trials. I discussed with FDA folks our predicament for NED/stage 3 folks and they very much agreed this needs to change. This will be my pet project! Nothing drastically new or exciting so far.

    Now hold on a minute, that IPI news IS new and exciting!

    Jeff

    #64596
    rosa11
    Participant

    Any talk about PD-1 being FDA approved any time this year?

    #64597
    Jonathan
    Participant

    Merck is hoping for an October FDA approval. In the press, so far ASCO coverage is mostly all about anti-PD1. Here’s one link to a NYTimes article.

    http://www.nytimes.com/2014/06/03/business/cancer-researchers-report-longer-survival-rates-with-immunotherapy.html?src=me

    I hadn’t quite realized the “feeding frenzy” that seems to be going on among all the pharmas about this – here’s something Tom sent me.

    http://www.thestreet.com/story/12725321/1/merck-immunotherapy-posts-striking-results-against-advanced-melanoma.html

    Jonathan

    #64598
    jamesa
    Participant

    Catherine,

    Hoping, once the FDA approves Merck Mk3475 on October 28, 2014, what information do you have about any restriction and/or criteria placep on qualifying to get Mk3475.

    With the Merck EAP, patient need to have failed IPI and Braf, if Braf positive before getting into the EAP

    Do you think that a patient would have to meet the same conditions under the EAP ,once FDA approves MK3475 before the doctors, medicare, & insurance companies would pay for MK3475.

    If so, that would be terrible. Mk3475 has a better response rate than IPI & Braf plus Mek. Why should a patient waste time & money trying IPI & Braf first.

    Please let us know what you have heard.

    Thanks,

    James

    #64599
    rochelle
    Participant

    James,

    I spoke with my oncologist about the inclusion criteria for the expanded Merck PD1..it seems the only qualifications are having melanoma and being 18 years of age. Others may have more info on this, but my doctor and I went through Merck’s protocol together, and that seemed to be the bottom line. It is my understanding Merck is not requiring any data from the centers opening EAP trials, though my doc will be conducting her own research. That’s why some of these centers are taking a little time to make EAP available and some centers received the drug and without creating their own research programs, just opened their doors and made the drug available to patients in need. I am unsure about the need to fail prior therapies because as I said, the inclusion/exclusion criteria seemed thin.

    Martha

    #64600
    Catherine Poole
    Keymaster

    Martha is correct. Also, the conference this afternoon pretty much concluded that the Merck PD1 is better than the Nivo by BMS. The IPI for stage 3 isn’t a done deal at all.

    #64601
    kylez
    Participant

    I had been wondering about this, Catherine:

    Quote:

    the conference this afternoon pretty much concluded that the Merck PD1 is better than the Nivo by BMS

    Was there any kind of indicator of how more effective they feel the one was over the other?

    #64602
    Violeta
    Participant

    Hi,

    for anti- PD1s some differences we can see in the indicator called OS rate.

    Bellow is some data Bettina posted on the blog ‘asco 2014” on melanoma patient network europe:

    For PD1 BMS:

    ”After 1 year, 63% of all patients are still alive.

    http://mpneatasco.blogspot.com/2014/05/long-term-survival-of-ipilimumab-naive.html

    For PD1Merck:

    ”In comparison, after 1 year on the Merck PD1, 86% of patients with PDL1 positive tumours and 72% of patients with PDL1 negative tumours were still alive as presented at AACR earlier this year.

    http://www.aacr.org/home/public–media/aacr-press-releases.aspx?d=3307

    #64603
    Catherine Poole
    Keymaster

    Violeta,

    How are things going? I posted Bettina’s blog below in a seperate post, it is quite good. But have been thinking of you.

    #64604
    Violeta
    Participant

    Thanks for asking , Catherine.

    what can i say.. is a nightmare. In the last month and half she had 2 blood transfusions and 3 times was treated for hipercalcemia and infections; she is bound to the bed and has awful pains. Apparently the mixture of dabra and trametinib is not so effective for her situation, but her oncologist is saying that it is keeping her alive somehow; we will go again for an evaluation at brussels at the end of june. Sometimes I hope for her, sometimes I am desperate. Most of the time I thanks to God she is still alive.

    #64605
    Arno
    Participant

    Hi all,

    I haven’t been active on the forum for a while (my wife was diagnosed with stage III melanoma 2,5 years ago, had a full lymph node removal in her right groin, and fortunately she has had clear scans ever since), but I just read a promising article which has not yet been reported here I believe.

    They are the first longterm results of a combination phase 1b immunotherapy trial for advanced melanoma patients combining nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4; Yervoy). Overall survival results are amazing – 94% after 1 year and 88% after 2 years! – but it is only a first phase trial, so not large scale and I don’t know how patients were selected. But regardless, these are the best OS results I have seen thus far for any treatment. Results will be presented at ASCO if I understand it correctly.

    http://www.sciencedaily.com/releases/2014/06/140602132230.htm?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+sciencedaily%2Fhealth_medicine%2Fskin_cancer+%28Skin+Cancer+News+–+ScienceDaily%29&utm_content=Netvibes” class=”bbcode_url”>http://www.sciencedaily.com/releases/2014/06/140602132230.htm?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+sciencedaily%2Fhealth_medicine%2Fskin_cancer+%28Skin+Cancer+News+–+ScienceDaily%29&utm_content=Netvibes

    #64606
    Violeta
    Participant

    Thanks Arno,amassing results indeed! i hear them from Bettina in her reporting liveblog from ASCO. My sis was unfortunately not a responder for yervoy and neither for nivolumab. I hope she is fitting now for the EAP of Merck, but..just curious if patients like her can be eligible for this nivo-yervoy trial.

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