Keytruda (and Halaven)

Hi, Milwmama. As I understand it, Keytruda has FDA approval for any type of cancer, including breast cancer, whose genomic testing reveals that it may respond. TNBC ought to be a good candidate. If your docs had a tumor sample tested for MSI or MMR deficiency, this info may help you get approval. It is not quite clear to me how bc stage figures in. Perhaps the insurance company is conveniently behind the times. Alternatively, going to the drug company is a good idea.

According to the article linked below, Keytruda "has become the first drug to be approved based solely on the presence of a molecular biomarker without regard to tumor location.The tissue agnostic approval "for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options," marks yet another milestone for the drug."

http://www.bioworld.com/content/mutation-over-loca...

Also, thanks to Cure-ious who posted on March 21, 2018 about a study that showed that "... a combination of pembrolizumab (Keytruda) while eribulin (Halaven)⁵ has produced a 26.4% ORR in 106 patients with metastatic TNBC who enrolled in the ENHANCE1/KEYNOTE-150 phase Ib/II trial."

http://www.targetedonc.com/news/trials-consider-ro...

This is more ammunition for your onc to use in the fight to get you the drug.

Milwmama- I'm part of the I-Spy 2 trial and I'm doing Neoadjuvant Chemo with Taxol and Keytruda. I'm not sure if you are comfortable with a clinical trial but it's another way to get Keytruda without worrying with insurance. Yes I had to qualify which I was surprised I did since I'm hormone receptor positive and Her2 neg, but my mammaprint came back high risk.

Today is day 5 of cycle #3, had the infusion of Keytruda and Eribulin (Havalin) day #1. I was able to go on vacation after the eribulin infusion only (scheduled for day 8) on cycle #2. Had to postpone infusion a few days due to low counts. Thankfully my DH was able to rearrange all the travel arrangements, and we were able to go with an onpro kit they put on my arm for an injection of neulasta to be given over 24 hrs later-technology!! Wonderful vacation! I've continue getting the flu like symptoms with the trial drugs, I think it is the keytruda, on day #2/3 that last just over 24 hrs. Then I start feeling better. The neuropathy that started with Abraxane is getting worse.....I'm thinking they will either need to reduce the dose or hold it on the next day #8.....if my counts are good enough to receive it then. My energy level has gone down, I'm sure it's the meds, but maybe feeling down after having such a great time away and having to come back to reality. Plan is to have a scan in a few weeks.

How are you Milwmama?

So, CT scan did show liver responding nicely to treatment, one met remains and it is smaller, the place on breast/axillary where it recurred showed skin/soft tissue/musculature thickening....they aren't sure what to make of that. No new active disease shown.

I did receive the pembro and eribulin last week, same flu like symptoms on day #3-4...low grade fever, aches, headache, NO energy. Oh, and my thyroid is now no longer working. I started having issues with it acting up just before I started this trial, so, I'm not sure it's to blame. Started on synthroid....hope it kicks in soon.

Was scheduled to receive Eribulin today, but had to have it held due to increase in neuropathy in fingers. I hate to hold it, but I couldn't open the Advil bottle, typing is getting difficult and I am fumble fingers. It tingles, is more intense now instead of numbness.....I don't want it to get worse.

Will cross post...

I have been intending to post earlier, but with the high dose steroids are making me a bit jittery and with the neuropathy in my fingers it has become more difficult to type....I hope it doesn't stay like this. I'm feeling much better. My headache is gone, cough gone, I have some energy back (not like Susan! wow). They are now attributing the thyroid (or now non-funtioning thyroid) to my immune system attacking it. The synthroid seems to be starting to kick in. Kidneys are looking better, I have an apt with nephrologist tomorrow. Keytruda and Halaven are being held....don't know it I will be able to take Keytruda again, but they are keeping me on the trial and tentative plan to start Halaven when kidney functions are normal. Apparently I'm one of the 1% that has this kind of reaction....leave it to me.

Well, an update....my kidneys responded really well to the steroids and my creatine is basically normal so I received the Halaven dose Tuesday, although the nephrologist said that Halaven would have been ok with some kidney issues and shouldn't be an issue. They are decreasing the steriods, but will take 6 weeks! They are negatively affecting my sleeping, so now I have to take something for that. But I was very happy to get the Halaven dose at a reduced dose. It's not clear whether I'll ever get the Keytruda/Pembo. The kidneys were a grade 2 injury, for the trial you aren't allowed to receive it again if you have a grade 3. So, we haven't totally ruled it out, but if I have a similar response in the future it may damage my kidneys worse the next time. If I don't get the Keytruda for >12 weeks I think I'm technically off trial. I really want to stay on it, or see what the next scan shows in Oct.

Minxie, I am feeling much better! Just a bit, although less, jittery from the steriods. I think my hair loss (it had started coming back on Abraxane) is from the Halaven not the Keytruda, and I still have tufts-like male patterned baldness. I hope it works for you! Would your insurance cover a chemo while Merck covers the Keytruda?

hi all, my MO just called and i will be dropping Kadcyla after only 2 sessions due to major progressions shown on my last scan. They are switching me to Keytruda with herceptin. it’s not approved for BC but they were able to get the company to approve it for me. I am not sure how since I am not on clinical trial.
I’m a regular and very grateful lurker here. It’s been amazing how much help I can get from everyone in this site.
I hope this combo will take care of my progressions. I have been stable with only bone/spine Mets for the last 4 years. So the last scan was pretty scary for me with lymph nodes, skin and the possible the other breast.
Thanks everyone, reading your posts helped lessen the fear of the unknown for me.

I am still confused as to whether they test MBC patients for the PD-L1 mutation to use Keytruda like I read they do for lung cancer or they try in a broader way and hope it works like they would expect for chemo.

Well, an update, I apparently have another Keytruda (immunotherapy) related complication, colitis. I started having diarrhea that was controlled by immodium. That stopped working and I had to switch to Lomotil but the diarrhea turned very watery-could see pills in toilet floating. I was having 3-4 episodes in a day (over norm), a tender abdomen on palpation, and cramps. Friday I was put back on high dose steriods (60mg) which made me MAD (!); I had just tapered down to 2.5mg from the earlier kidney issue. I see a gastroenterologist tomorrow-nice to been seen so soon! They will probably want to do a scope, and we'll see what else. I've heard there is a steriod that just effects the GI tract....I hope they can switch me to that! This systemic steriod, prednisone, I don't like.

I'm actually feeling pretty good overall. Bummer. I was able to get the Halaven (eribulin), so that was good and they thought I was slightly dehydrated so they gave me extra fluids. I have scans in a couple of weeks....it's hard waiting especially with this new complication.

This is cross posted.