Anti-PD1 after Ipi
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I have read a couple of anecdotal reports of patients who failed ipi then getting anti-PD1 and having success– even shrinking bone mets. I know that there was a clinical trial a year or so ago specifically designed to see the effect of anti-PD1 in patients who had failed or progressed on ipi. Any one know how it worked out? Have those results been published? I haven’t seen any published results, but PD1 has about a 38% response rate, much higher than IPI at 20% or less. Whether what you are describing is the combination of the two, I think we are hopeful that will result in better efficacy. But he trials are still underway. I would look to ASCO in June for reports or maybe sooner. Hi, any anti-pd trials ongoing? we have done yervoy but tumours progressing and now there is mets to the bones. Oncologist recommended chemo (abraxane/carboplatin/altuzan) wondering what to do? anti-pd for some reason is less discussed: june FDA approval unlikely? also anyone heard of any results? pls help…. Hi Pat, http://www.clinicaltrials.gov is the place I turn to for seeking the latest information on trials. I had heard there were slots opening up for ipi refractory patients on the Bristol Myers Squibb studies. Catherine always seems to have even more up-to-date information than that.Have you been tested for potential efficacy with Braf inhibitors?
There are plenty of blogs out there by folks who have had positive results with PD-1 including “Chaotically Precise” by Celeste and “Patient #1” by TJ Sharpe.
While no one knows for sure when the PD-1 drugs will be approved, but rumors have included the promise of April 2014, May/June pre-ASCO conference and a July 2014 application for Merck.
You are not alone in your hope or anticipation, that is for sure!
Leslie
There are no PD1 trials accruing that I can find. They are closed and readying for approval and possibly EAP (Expanded Access Program). PDL which works hand in hand with PD1 is coming to trials in combination with braf/mek or just mek and in other trials. I would look for those for now. June is the month projected for approval, but sometimes these things come sooner! Everyone likes to make a splash at ASCO! I would reject the chemo combo at this point because it is not proven to work well for melanoma I would check out the ADC trials too. You can email me personally to help you look: cpoole@melanomainternational.org and we provide scholarships to patients who need to travel to trials.Thank you Catherine…what ıs ADC? my dad is brad negative and ıf we reject the chemo what are the options? if we wait until july for fad approval of anti-pd is it not too late? thanks so much for your reply.. There is a published report on nivolumab followed by ipilimumab – thought the data set is small. Here is the presentation of the same :
http://www.projectsinknowledge.com/Activity/pdfs/2173_02.pdf There are many single agent / combination trials of pd-1/pd-l1 agents that allow prior ipilimumab ; you may want to consider those. Example being single agent medi4736 or nivolumab + anti-kir etc.
There is obviously a lot of excitement and anticipation regarding the approval of anti-PD-1 (me too!). As noted by others, from the media reports, it seems like Merck is in the lead with intent to file with the FDA by June. However, from everything I’ve seen on this, the approval will be limited to patients who have previously been treated with ipi (and progressed–see the quote pasted below from a recent Forbes interview with MRK’s head of R&D). One might speculate that BMS will seek a similar limited approval–one that requires patients to first use its existing blockbuster, ipi. Folks should keep this in mind in developing their treatment plan in the coming months as being “ipi naive” may be an obstacle to receiving anti-PD-1 even after it is approved and available. -How can Merck file with the Food and Drug Administration for its programmed cell death receptor 1 (PD-1) drug, MK-3475 for melanoma before rival Bristol-Myers Squibb BMY +0.61%, which has presented more advanced data on its similar drug? Perlmutter says he won’t commment on Bristol’s data, but that MK-3475′s “breakthrough designation” helped speed communication with the FDA. The agency was willing to consider approve the drug because it shrinks tumors, without survival data, only if there’s a population of patients who have no other options. In this case, the FDA will view an application for MK-3475 in patients with advanced melanoma who have failed Bristol’s Yervoy. There’s about 9,000 patients with disease that advanced, and Yervoy helps about 10% of them, he says.
Andy, thank you very much for posting the link to the BMS data. The study was moderate in size but the data is compelling, especially the 1mg/3mg PD1/IPI combination. Though the response rates were similar to that of the two therapies combined, the depth of the responses were considerably deeper and quicker than those of the individual PD1 and IPI combined. Can’t wait to see the follow up data to be presented this year! Many good things are happenning!!
Jeff
After I read this thread I tried to do some research for PD1 trials for people that failed ipi, and the only one I was able to find is the one I’ll post below at Moffit. If you guys have any other links to similar trials in US or Canada can you please post them below, I’m still trying to find some plan b, c, d. Thank you! http://moffitt.org/research–clinical-trials/clinical-trials/clinical-trial-15400 Dr Jedd Wolchoks presentaton at ASCO 2013 http://www.projectsinknowledge.com/Activity/pdfs/2173_02.pdf Best is ipi and PD1 together. Interestingly those who got stable disease on proir ipi all showed response (that s of those in his study) to anti pd1. Those who did not respond to ipi still some responded to anti pd1.
Asco 13 for immune therapies very interesting ipi response is improved with GMcsf and side effects less.
Well as far as I can understand.
Interested in others interpretations
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