Home Forums Melanoma Diagnosis: Stage IV Opdivo Approval: The scoop

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  • #22283
    Catherine Poole
    Keymaster

    Ok, so the BMS version of PD1 won accelerated approval for melanoma (unresectable metastatic) as a third line therapy. Patients must have failed IPI and if BRAF positive, failed Braf therapy. The Phase III data showed a 32% overall survival rate and of those 87% ongoing response. Dosage will be 3mg/kg, top issue, rash, then colitis, and thyroid issues. Pneumonitis most serious side effect.

    Will be available to patients in January. More data on the IPI/Pd1 combo trial (phase III) will be coming in the 2015.

    #65969
    rick1981
    Participant

    Hi Catherine,

    Great news!

    Any scoops for Europe? :)

    And is it allowed to use Opdivo after failed Keytruda?

    Thanks, Rick

    #65970
    Linny
    Participant

    At first I got all excited when I saw the headline about the approval. But it seems so bittersweet in that for how it would be a 3rd line therapy.

    #65971
    Brendan
    Participant

    Thanks, Catherine.

    I am currently in a nivo trial. I had infusions every other week Jan-June. I am now on maintenance phase so infusions are every three months. I was in an ipi-refractory trial and I had a small met in my left lung and the target met was in my right lung (4.6 sq cm I think?). Thankfully the target met in shrunk over 90% and now measures 5mm x 6mm. The smaller met in my left lung was gone within the first six weeks.

    Fatigue was the only side effect I noticed. However, the it hit me pretty hard. I fly from Philadelphia to Tampa for the trial. The trial ends in June 2016 (2 1/2 years total). Does this approval change anything for those of us fortunate enough to be in a trial?

    Thanks for everything!

    Happy Holidays,

    Brendan

    #65972
    Catherine Poole
    Keymaster

    Linny, I was disappointed too, I thought the data was mature enough to be first line. I am told that should happen shortly with Keytruda to switch over to first line. As for trials, Brendan, they normally continue until they are targeted to end. I would call the investigator and ask. I have asked Rick’s questions about global approvals and whether you can fail keytruda and still get opdivo. I will tell you more when I get answers.

    #65973
    MathewR
    Participant

    Brendan, great news–I’m glad to hear that you’re continuing to do very well on nivo. Happy holidays.

    #65974
    Catherine Poole
    Keymaster

    Whether you can take Opdivo after failing Keytruda may come down to the insurance company decision. And as for global approvals, no answer..

    #65975

    Just a few questions…if both Keytruda and Optivo are PD1 meds, do they work similarly but just distributed by different and competing pharm companies? As others have asked, if Keytruda does not work for one, does it reason to assume that Optiva will not work as well or does it work through a different mechanism? I had read that Roche and other pham companies are also working on PD1 meds….are these the same meds as other PD1s or can we consider those as other tools in the toolbox?

    #65976
    rochelle
    Participant

    I am currently receiving Keytruda and radiation as part of a study and I asked the same question…is Opdivo any better than Keytruda. According to my oncologist the answer is no. The only difference is this…Keytruda is given every three weeks and Opdivo is given every two weeks.

    #65977
    Catherine Poole
    Keymaster

    Until these therapies go head to head in clinical trial we won’t know. The latest stats I read said Keytruda was 38% for response and Opdivo a little lower at 32%. The others are coming along and I hope we get better response rates. And don’t forget PDL which might surpass the PD1 molecules. Unfortunately, only time will tell and rigorous clinical data with large numbers of people.

    #65978
    rick1981
    Participant

    Hi Rochelle,

    Do you have Some more info on your trial? Do you experience some benefits personally from keytruda plus radiation? Is it difficult physically and psychologically? I heard radiation is given 10 days in a row?

    Anyway, hope it’s working for you!!!

    Rick

    #65979
    rochelle
    Participant

    Hi Rick,

    I’m not on a trial…but I am part of a study. The study is hoping to show a synergist effect of combining Keytruda and radiation. Four years ago I was part of a study combining Yervoy and radiation and I was stable for quite a bit of time…about a year and a half.

    This time around I had proton radiation which is very precise and given in smaller doses thank traditional radiation…I only needed three doses. I was experiencing tumor reduction before the the radiation (in response to the Keytruda) so I am hoping to enjoy the same benefits I had with Yervoy/radiation. As far as the psychological/physical aspect…I will say it was tough getting it all done this time of year…my travel time for treatment is a five hour round trip…every other day as well as a treatment day so I was running in and out of NYC, but this time of year New York can be great…I just do what I have to do..its all good.

    Thanks for asking and I hope my experience can be helpful.

    Happy New Year!!

    #65980
    Catherine Poole
    Keymaster

    Rochelle,

    So good to hear an update from you! How big is the study? Do you know how many participants?

    The previous studies with IPI have been very small, so this could be really important to another good use for immunotherapy. Also, brain mets and bone mets seem to happen a lot, so combining the two therapies would make sense. Many docs have patients stop the immunotherapies while undergoing radiation. Keep us posted! And happy healthy new year!

    #65981
    rochelle
    Participant

    Hi Catherine,

    Merry Christmas and Happy New Year to you!!

    As you know I am being treated at NYU so I would venture to say this is a rather small study restricted to NYU. I do know there is a sequence to this study…it goes as follows…baseline PET scan…treatment with Keytruda…followed by three doses of radiation. Then proceed with treatment as usual…without interruption. I do not have brain or bone mets but I had a very large sub-q lesion on my left cheek that was the target tumor. (Which incidentally was already beginning to regress without radiation due to Keytruda.) But we stayed on course and radiated it anyway. The thought is to stimulate the immune system even more with the radiation and get more bang for your buck from the Keytruda. As I said in a previous post…I did have a good response after my third round of Yervoy/radiation…I was completely stable for about 18 months…hoping again for a similar response.

    I am curious why other docs stop treatment while the patient is receiving radiation…any idea why?

    Martha

    #65982
    Catherine Poole
    Keymaster

    I’m not sure what the rationale is, but possibly they don’t want side effects from the systemic therapy to interfere with the radiation treatment. It seems like a new frontier since they won’t let patients with brain mets undergoing radiation enter clinical trials for the most part. There may be other drugs that work in synergy with radiation. I am also very interested in the Proton therapy and how that pans out vs. traditional radiation. This would be a great topic for our webinars.

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