Home Forums Melanoma Diagnosis: Stage IV anti-PD-1 We need it now

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  • #20587
    alankravitz
    Participant

    As many of you may know, I have been a participant in the Phase 1B anti-PD-1 (MDX-1106, BMS-936588) trial for 4 years and have been NED for over 3. As a melanoma advocate, I follow postings on the many melanoma related sites and forums: over the past few months there have been a vast number of postings by patients for whom recently approved therapies no longer keep melanoma in check. They are crying out for anti-PD-1 and, especially the version from Bristol-Meyers. We need anti-PD-1 and we need it now!

    Bristol- Meyers might not have the results it requires for FDA approval but it does have results that are more than adequate for them to make it available on a compassionate use basis. Response rates are high, durability seems to be good, toxicity is low and controllable, and there are indications that PD-L1 may serve as a marker and lead to even higher response rates. While BMS is to be commended for making anti-PD-1 available for reinduction to previously treated patients, they have been reluctant to provide it for compassionate use. They have, thus far, resisted efforts by the Melanoma Research Foundation’s Breakthrough Coalition, other Advocacy Groups and individual oncologists. BMS has proposed a strategy that will not start a Phase 3 trial until 2013 and probably not make the drug available until 2016.

    We need to launch a broad-based, highly visible effort to redirect BMS’ s anti-PD-1 strategy. We need to get all the stakeholders on the same page: Compassionate Use and Phase 3 Clinical Trials Now. Let’s develop a strategy and get to work.

    #56249
    Catherine Poole
    Keymaster

    Alan,

    We’ve worked closely with MRF and BMS on this issue to no avail. I’ve personally had meetings and follow up meetings. There are other PD1 agents out there that are working well and we are lobbying them. So we are allocating our efforts towards those with hope of an approval soon or at leasted an expanded use program. I don’t believe the BMS PD1 will be moving as quickly as the others despite being around longer, just my guess based on hearing the 2016 date also. But the effort by MIF has been made, I assure you both along side MRF and alone.

    #56250
    rbruce
    Participant

    Have just received my 24 week scan results on Merck Anti-pd1. Over 60% reduction in lung Mets, 50% reduction in axillary lymph node and huge decrease in suv, and my 2 rib Mets aren’t showing up at all anymore.

    I firmly believe that for those whose tumors express the pd ligand, and according to ASCO reports on BMS version, that the potential is too great not to “storm” BMS and Merck with letters, calls, press etc., to make compassionate use available for stage IV warriors. Unfortunately, with BMS having paid such a high price for Yervoy, and wanting to recupe their investment I think we have a better chance with Merck. I think it’s time we “make some noise”. Open to ideas! Robert

    #56251
    Sharmon
    Participant

    How can I get envolved. If we can stand together we can make a noise.

    Is there a committee somewhere to send our pleas to for compassionate use?

    #56252
    Catherine Poole
    Keymaster

    I will pull together some of the people who may be able to figure out the most effective way to campaign for this. We have been pushing close to two years and haven’t gotten far with it. We have joined other groups as well in the effort. I am hearing a lot more trials are opening up and certainly there’s a lot of competition among the pharma to push them to market. I’ll be thinking of strategies and let you know. So far, the BMS and Merck pd1 are the most promising I’ve heard from investigators. And you can always write your congressperson and ask them to push for this and funding for NCI as well for melanoma.

    #56253
    LynnLuc
    Participant

    Catherine, It also looks like BMS is test driving the anti-pd-1 in other trials for other cancers etc ex…http://clinicaltrials.gov/ct2/show/NCT01592370 Safety Study of Anti-Programmed Death-1 in Hematologic Malignancy

    I wrote them again to find out whats going on with BMS-936558 . They will usually call me about a week after I write them, so if I hear anything I will let you know.- Lynn

    PS I think part of it is possibly the findings that people without PDL1 do not respond to Anti PD 1. In June BMS had over 110 of us at Moffitt in the Anti PD-1 ( I think they are testing over 300 altogether ) sign a release for 6 unstainned tumor slides to test for the PDL1. If they find this to be true then patients won’t be wasting time in a useless trial. I am thinking if this is true then they will probably start testing for PDL1 like they do currently for the B raf mutation for Zelboraf and or KIT.

    #56254
    Catherine Poole
    Keymaster

    Thanks Lyn. Yes, BMS may go for approval of PD1 in Lung or Renal cell carcinoma. There would still be the opportunity for off label for melanoma, but maybe more difficult with insurance. And the testing may be coming. We discussed that in the webinar a bit last week. But so far there is no standard test to find out if you are positive for it. Let us know what you hear.

    #56255
    alankravitz
    Participant

    Lynn, Catherine et al,

    BMS doesn’t have an approved test but they do have a test to establish the presence of Pd-L-1 that they will use on the data they are collecting from former trial participants as well as data from the upcoming biomarker trial. Please note that they are launching the safety study in hematologic malignancy and advanced tests for NSCLC and Renal cell without having an approved biomarker. Why not for melanoma? LET’S FACE THE REALITY THAT IF BMS WANTED TO, THEY MIGHT HAVE A VERY GOOD CHANCE OF GETTING FDA APPROVAL OF anti-PD-1 WITH THE DATA THAT THEY ALREADY HAVE AND COULD CERTAINLY MAKE IT AVAILABLE FOR COMPASSIONATE USE.

    I simply cannot understand their reluctance to move forward rapidly: they need the revinue to maintain their stock price given the loss of patent protection for Plavix and the recent withdrawal of their hepatitis c product from testing; the failure of many national regulatory agencies to approve Vervoy as a first-line treatment and the failure of many national cost-effectiveness organizations to recommend reimbursement for it; the increasing tendency of oncologists to use BRAF targeted therapies for first-line treatment of patients with the requisite biomarker (see the Kantar Health Survey of Oncologists at ASCO 2012); the rapid advancement of competative versions from Merck and others; and the broad support of anti-PD-1 from all facets of the melanoma community.

    They need it now as much as we do!

    Alan

    #56256
    Catherine Poole
    Keymaster

    As I mentioned Alan, we’ve been working on this for over a year, lobbying BMS and working with other melanoma groups to push it forward. But your guess is as good as mine as to what is holding up the process. I cannot get an answer. So hopefully the competition of many other pharma (GSK, Genentech, Merck) will push BMS to approval/compassionate use. It would potentially save lives!

    #56257
    rbruce
    Participant

    I really think the best way to get eyes on the issue is grassroots. Something like “Melanoma Patients United” where we, the patients, are the front line with the support of organizations like Melanomaintl, MRF, MRA and others. There is so much info out there on how to stay sun safe, how to detect, etc., but patients that are Stage IV have the greatest short term need of any group just trying to extend their lives and lessen the pain. If Katherine or someone could lead us off with maybe a conference call or webinar, we could get organized and put together a plan. I would be willing to do whatever it takes and assist in any way. What to you think? Robert

    #56258
    rbruce
    Participant

    Sorry, that’s Catherine with a “c”. :)

    #56259
    Catherine Poole
    Keymaster

    Thanks for your kind offer. I will send an email to the leaders of MRF and MRA and see if they’d like to collaborate. We have done so with a campaign together with MRF in the past few months with no progress. They really aren’t listening to us right now. They have some constraint that they aren’t providing any openess about. I will see what I can do, but it is pretty complicated and not easy to tackle a giant pharma!

    #56260
    pati
    Participant

    I must admit, after much political lobbying, and discussing and trying to understand where patient / industry / regulatory rationales meet, along with Catherine and MRF and others, that I come to the conclusion that there is no “logic” to be found for why anti-PD1 has taken so long to take off. IF we are trying to find “compassion” in that logic. It is unbearable for us living with the disease because we are simply not operating in the same landscape as those who make decisions about the $$$ that then become pipelines and trials – I am not talking here about the scientist, nor the poor people who actually are in roles set to try to relate with patients, they try! But I am talking about the finance and marketing of it….at the end of the day we are only a $ a “consumer” on these profit making economic models, often decisions are made on our behalf, for our “safety”, we are spoken about without really asking us. If only we could lobby by not “consuming”, but at stage IV we are trapped by the disease and lack of durable treatment options…we are actually an easy population to manipulate and control because we are small, not really organized politically, and we advance/die quite fast. If it was not for people like Catherine whom takes more than she can on her shoulders we would actually have a harder time. I am really losing all hope that there is any “reasoning” to be done about anti-PD1 when the race to get a good slice of the increasing melanoma market is only starting. If only we are as numerous as breast cancer patients, or as strong identity and political as HIV/AIDS patients. But we are not. What would another round of letters/emails do? what would another TC call with the anti-PD1 teams in different pharma groups do? Is there a more creative way to express the “ras le bol!” – french for enough! the urgency for anti-PD1 (like recruiting a politician or a TV documentary/news testimony ???)

    literally sick of waiting.

    P

    #56261
    Catherine Poole
    Keymaster

    I think some HIV folks sat on Merck’s doorstep to get their attention. Could we get some movie stars to speak out? I’m asking those I know. And I meant to mention that the researcher/doctors have also been pushing and haven’t not gotten anywhere. Thanks Pati for your input and Bruce don’t worry about the spelling, it sounds the same! OOps meant Robert.

    #56262
    alankravitz
    Participant

    Pati,

    I couldn’t agree more, polite reasoning with BMS for advanced trials or compassionate use isn’t working. You are echoing an argument I have been trying to advance since 2010 when I read the first published results of the Phase 1B clinical trial of MDX-1106 and of the oncology community’s response to those results. After learning more about the problems associated with drug approval and patient access, I purchased a copy of Steven Epstein’s book. Impure Science, to better understand what it took for AIDS activists to overcome the regulatory, insurance and medical establishments in addition to the drug companies.

    It took them a lot more than the letters and meetings that seem to be the limits of action by professionalized melanoma advocacy groups. It required a wide range of political action by quite a diverse group of organizations and individuals both inside and outside the gay social movement. The actions included many forms of direct non-violent action ranging from street theater to sit-ins. They had a bit of a head start because they were part of an established, visible social movement for gay rights that recognized the importance of direct action in their struggle. Our heritage is considerably more tame: too tame to accomplish our present objective. What the advocacy groups can give us is a way to reach out to patients and caregivers. Picking up on what rbruce suggested, perhaps MIF would give us a Forum devoted to patient activism. If not we must look elsewhere or develop our own means of communicating.

    As to action, I have been thinking of a two part strategy focused primarily on BMS. The first part involves attacking the financial logic behind their melanoma strategy in general and their anti-PD-1 strategy in particular. They are extremely vulnerable in financial markets due to a history of slow revenue growth, the loss of patent protection for Plavix, the withdrawal of their hepatitis C drug, and the marketing headwinds they are facing for Vervoy both domestically and internationally. I have been working to get this argument out to analysts that cover them. I would also like to get people to buy a share and attend their Annual Shareholder Meeting. The second part involves making a strong case to other stakeholders and the general public. It requires letting the public know in highly visible ways that will attract sympathetic media attention and additional public pressure on BMS. We should have people; I prefer to call them activists, at every event dealing with melanoma and, possibly the other indications where anti-PD-1 has posted encouraging results including local support groups. I would be at every corporate event they hold. I would try to get congressional oversight committees to look at the obstacles presented by the regulatory process, patent law and how we incentivize drug development. I would meet with scientific and professional organizations and try to get them to be more outspoken about what they have already acknowledged in polite tones.

    At this point we need to gather our troops, brainstorm about strategy and tactics and find a way to communicate.

    Alan

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