I promised Kevin I would show some of his latest work here – a condition for letting me keep one I fell in love with! An easy price for some cool stuff! So in addition to the update for what’s coming in terms of treatments this month, I thought I’d also show his recent ceramic work.
So, here’s what’s up for May.
Due to the clinical trial status of Anti-PD-1 (MK 3475 or lambrolizumab), Kevin must first try FDA approved meds. This is simply how the system works. Due to the half-life of Mekanist, he had to go a few weeks without it and taking Tafilnar only. The waiting phase is nearly done, thankfully.
So, the next in line, possibly starting as early as next week, is Yervoy (Ipilimumab) – an immunotherapy drug. This drug will basically remove the “brakes” in his immune system, allowing his body to fight like crazy. While it carries some pretty sobering warnings, I’m told most people have very few side effects. The drug will be delivered via a 90-minute infusion every three weeks. Kevin is required to do the 9 weeks, unless side effects are dangerous or the melanoma continues to grow. If either of those two things happen, they immediately take him off of Yervoy and start him on Anti-PD-1.
A little bit about Yervoy.
Yervoy, just FDA approved in March 2011, is still considered a farily new drug in the fight against melanoma. Before that, the last “new” med for melanoma was introduced in the mid-1990s. The immunoglobulin from which Yervoy is made is produced in Chinese Hamster ovary cell cultures. I always did like hamsters.
Yervoy works on the principle that tumors emit a specific antigen (think of it as a radio signal), so antibodies created via Yervoy’s intervention can theoretically wage war on cells emitting that signal, preventing autoimmunity. This kind of frees up T-cells to do some major ass-kicking. While Yervoy doesn’t directly attack melanoma cells, they think it helps T-cells ignore the signal from melanoma cells, and fight, fight, fight.
This fighting is a double-edge sword, however. Because ipilimumab makes your body create tons of T-cells with no restraint, there’s a risk of immune-related reactions – some extremely serious in about 10%-26% of patients, or even fatal in a fairly low percentage – like between .02% – 6% in studies. We were assured that this is the minority, but that the risk still exists – and no one knows why or whom will be affected.
Kevin, knowing that his current treatments will eventually become ineffective, decided this is what he wants to do. This is the road to the medication we sought through various clinical trials in Nashville, St. Louis, Chicago and the University of Iowa. It’s a much-coveted opportunity, and while the risks are very real, it’s the first real chance for many with melanoma to actually fight the disease and win. We hope Kevin will be among the first to survive this terrible disease.
So, worst-case scenario, Anti-PD-1 will begin in about 10-11 weeks.
Anti-PD-1 carries risks of its own – firstly that 41% of the people in clinical trials respond to it. That said, however, it is the drug most cancer patients are petitioning Merck for compassionate use due to its efficacy. So, we have high hopes it will be effective. FDA approvals should clip along quickly, allowing Anti-PD-1 to be approved for melanoma first in October 2014 – taking the fast-track due to the urgent need for it.
Meanwhile, Kevin’s doing a great job maintaining grace under pressure. We constantly try to frame this experience of his into this being like a long-awaited vacation, whenever possible. It’s a lot of psyching up to do, but thanks to his humor, and his not getting sick of my constant reminding that we must ride the storm, he gets up every day willing to live to the fullest.
We also thank those of you who continue to pray, who have helped us with stuff, money and kindness. There is no way to go through these things without that kind of support.