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June 17, 2014 at 2:05 pm #22036cherisParticipant
Hello, Catherine and everyone,
I am NED at this point, my onc wanted me to begin Ipi last week after having a tumor removed from my lower intestine 6 weeks ago. I have decided to delay the treatment until the end of July. I am going to enjoy my treatment-free life for a few more weeks with my husband on a pre-planned trip. I’ve also decided to take this course after much research on Ipi.
My big questions now forming is: Do I forgo Ipi as long as I’m NED, or do I start a Braf treatment? The data seems to be showing that being Ipi naïve has better results with other targeted treatments (I’m Braf pos.)
Very wearing trying to make the right decision. I know my doctor is sincere, but somehow I don’t agree with Ipi. Thanks so much.
CherisJune 17, 2014 at 8:16 pm #64697
I can see your quandary. As I mentioned in the previous post, we have little information on these therapies used as adjuvant therapy (to prevent tumor formation) yet I think if I were in the position that there was potential for recur, I would choose something to prevent this. Immunotherapy would be my first choice and although not available, one of the PD1s would be the choice. I don’t know if the approval will allow NED patients a script or not, I’ve been asking around to find out how that is going to work. I think a targeted therapy such as the BRAF wouldn’t be appropriate unless there was tumor activity. Take some time off and enjoy the summer. I hope to have some more answers coming soon.June 18, 2014 at 6:45 pm #64698cherisParticipant Thank you once again, Catherine, I would gladly travel to get PD1 if it were given to NED IV patients.
CherisJune 18, 2014 at 8:12 pm #64699
Sadly, my research is showing that it PD1 (Pembro) after approval will still have the restrictions of prior IPI and/or BRAF.June 18, 2014 at 8:39 pm #64700RJoeyBParticipant That’s too bad. Interesting, but I suppose not entirely surprising. Despite the improvements over ipi, the trial data I guess isn’t as “mature” as ipi was when it was granted approval. So perhaps part of the bargain they made to get breakthrough designation and accelerated review may be that the approval, at least initially, will be somewhat “provisional” (not sure if there’s an official FDA category for that) until results from more Phase III studies are completed.June 19, 2014 at 6:02 am #64701msue5Participant Catherine Is there something in writing about these restrictions that you can refer to or is this just via the grapevine? Also I have wondered what the term failed Ipi and BRAF really means. Ipi was successful for me but I am showing signs that it has stopped working and my next step was to repeat Ipi depending on scan results in about a month and switching to Anti pd-1 when approved. It has been almost a year since last infusion. I was on Zelboraf on and off for about 6 weeks and was taken off due to 3 squamous cells that had to be excised. Also Zelboraf was not appropriate at the time because I did not have large tumor load but a consult with Dr. Atkins from Georgetown resulted in him saying he would never give a Lupus patient immunotherapy therefore Z was started. When everyone agreed I couldn’t keep having excisions every week Ipi was started. Are either of my experiences considered failures therefore making me eligible for Anti-Pd-1? My plan was to repeat Ipi until Anti Pd1 was approved. Also do you know if auto-immune patients will be excluded when approved? I did Ipi even though not recommended for Lupus pts because treating my Melanoma was worth the risk.This is messing up my plans big time!
Mary SueJune 19, 2014 at 12:04 pm #64702rosa11Participant
are you saying that after the FDA approval of PD1, in order for a patient to be eligible they have to have failed IPI and BRAF/MEK inhibitor(if positive)? I have failed on IPI but since my tumor load is low, for now at least, I was trying to save the BRAF/MEK as a last resort, hoping for PD1 to be approved in the meantime. I don’t like this one bit. So disappointed!June 19, 2014 at 12:06 pm #64703
We will not know until the approval goes through, but I have a conversation planned with the FDA and hope to find out more. The manufacturer won’t tell me and other contacts say this is how it will go. I will definitely be voicing the patient’s opinion that this isn’t right. MarySue, I think you would be considered as having progressed on IPI and therefore qualify.June 21, 2014 at 5:25 pm #64704GillyParticipant I can’t understand why they are still insisting on failing Ipi when the ASCO presentations suggested little difference between Ipi and Ipi naive patients ? Is it to limit the numbers while there are Merck supply issues ?June 21, 2014 at 8:30 pm #64705 Here is what i understand by reading between the lines from folks at Merck and the FDA. Merck doesn’t have mature enough data yet on the PD1 for the accelerated approval coming up, there is mature data on IPI, even though so far it seems inferior to PD1. Until Merck proves in a phase III trial that PD1 has a better response than IPI, IPI is the approved drug that must be tried first. Now there is a phase III trial that should be completed shortly that will most likely prove the benefit of PD1 over Ipi. Once that goes through, (estimated 6 months) the PD1 will open up to all patients. As for your doctor, they may look the other way on these requirements and just prescribe it since truthfully who will know if you failed IPI? It is pretty nebulous. The system isn’t quite that adept at figuring things out so I assume many kind docs will go ahead and prescribe or maybe not. I would!
PS no one has seen a requirement to fail the braf therapies..so there’s thatJune 21, 2014 at 10:28 pm #64706msue5Participant
Thanks for the update. Keep them coming. I know there a lot of people anxiously awaiting for PD-1 myself included. I am lucky to have the choice to redo Yervoy and I don’t want to use BRAF until I have to.
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