Are you currently (or have you been) in a Clinical Trial?
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Nicole that was the new big thing - it seems to work beyond the her2+.
The whole her2 low category is all in question because they gave it to her2 ZERO pts and some of them had response. I'll try to find the details and post
So this is from the DAISY trial. This chart is for cohort 3 which were all IHC = 0 for HER2. On the left are triple neg, on the right are HR+
from my notes from the abstract: response rate among tumors scored IHC =0 was 30%
I saw one explanation that said ALL tumors express HER2, and that IHC 0 is a failure of the assay to capture it. So I think they're saying that HER2+ are super enriched with HER2 but that we all have some.... so these drugs that are working so well for her2 might be applicable to a lot more patients, but we will get smaller response. That was my understanding of it anyway...
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WOW Moth thank you for explaining that !!! That is amazing...I guess the big thing would be getting our MO's to understand this and agree to try it on mTNBC and then insurance to cover (since its normally approved for HER+)....\
Yes if you can find the details and the post please let me know.
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Cure-ious and Moth,
Thanks for the highlights from SABC! I got on a few recorded sessions but didn't have much to say about what I saw. I'm so glad they are rethinking the HER2 categorizations. HER2+ was only set at 3 because it was where Herceptin started working. Now there are stronger drugs that can work on HER2 low or even HER2 0. You are considered HR+ if you are even 5% positive. We need the FDA and the drug companies to think that way about HER2 positivity.
Hugs, Susan
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Ehe, guys, regarding her2 ADCs - ,,I told ya":) HR+ and TNBC patients WILL benefit from these drugs because cancer is never heterogeneous. Even large portion of TNBC cells in tumors have enough HER2 expression, so ADCs like TDXd can bond to them and kill them, and exploit the bystander effect to kill no-HER2 expressing cells nearby, therefore IHC0 get 30 % response. Next step, I think, will be dual anti-her2-trop2 ADC by Daichi Sankyo, which will be great for both HER2+ and HER2-. We'll add a CDK inhibitor as a combo to HR+ patients, Tucatinib to HER2+ patients (already in trial DB-09), some chemo/vaccines to TNBC patients and CURES WILL COME. Let's hold on, MBC future is bright and already here!
Saulius
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Saulius, while I don't fully understand much of what you wrote, I know you do and I love your enthusiasm and your optimism for the future of MBC treatments. From your lips to God's ears!
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Dear MoCoGram, I am optimistic because I see that young generation of Oncologists is optimistic (what you never saw before), and big-pharma finally jumped into metastatic setting. Many questions have to be answered yet but the the "skeleton" to understand cancer is already here. Solid tumors are the hardest because of microenvironment and delivery problems but they will be solved. For the beginning we need at least to control this disease, i.e. to give patients a chance, a glimpse of hope, and this, I think, is already here or very very close. TDXd is a good example - > 6 % complete responses after average of 6 line treatments before... this is a miracle... means 6 out of 100 see their cancer disappear -> tumor mutational burden is minimal or not seen. After median previous 6 lines of treatment! How can we not be excited? Even the word "possibly cured" starts to appear in scientific journals which was a complete taboo even 5 years ago. That is simply amazing, I think. My wife is young, we have a small child, whole life should be ahead of us, and we went through hell, and still are going, but yes, I am optimistic. I have to be...
Saulius
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I was initially diagnosed in 2003 with DCIS following my first mammogram at age 40. I received a lumpectomy and 7 weeks of radiation. In February, 2017, I was diagnosed with reoccurrence same breast and received a bilateral mastectomy with reconstruction surgery and started on Tamoxifen. In February, 2021, I was still taking Tamoxifen but felt a hardness in same breast same area and it was biopsied. Diagnosed Stage IV/MBC. I receive care at Memorial Sloan Kettering and I am in a clinical trial for LY3484356 which is an oral SERD in place of the fulvestrant injection. I also take Verzinio and Xgeva. In the beginning of my trial I had weekly visits for 8 to 10 weeks, then twice a month for 5 weeks and then once a month there after. I had all my scans redone and receive scans every 8 weeks. I receive all my medications right at Sloan. I am very happy with the excellent care and attention I receive there
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Living-with-cancer, where are your mets? Glad your trial is working for you
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OK HEAR YE, HEAR YE....
CURE, MOTH, SUSAN , BEV and our BELOVED SAULIUS.....CAN I JUST SAY THANK YOU!!!!! I LOVE YOU GUYS!!!!! Not only do you take the time to explain things so we understand it but you do it sometimes more than once (chemo brain here guys on 8th treatment line) but seriously I just want to take a minute to say thank you so much!!!!! Also because of my great cutting and pasting skills to my MO you guys make me look smart LOL LOL
Had my first Trodelvy today. Did ok side effects expected Day 3-4
I spoke to the Measels MAYO CLINIC trial...unfortunately they cannot allow any blood work labs outside MAYO so I made the decision to do the Trodelvy for 3 months and if its still open and we don't see a better option we are gonna apply and I will try to Stay at a Fischer House (Its for military members and family gettting medical treatment in the area) they are 1 hour from MAYO. Thats my plan.
REF: ENHERTU...I wonder how long it would take to get approved for TNBC? Otherwise maybe I could get in that trial....
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Thanks!I have bone mets: spine, ribs, sternum, iliac bones and right hip. Also had mets in my liver but that is showing NEAD at this time.
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Nicole,
You are most welcome.
Why not stay on Trodelvy if it is working and you don't have any bad SEs? I was on it for a year after six previous treatments. With the measles vaccine trial I believe they can only treat one tumor at a time and it is still very early in development. If you can be on an FDA-approved treatment instead, why would you want to take that risk and all of the hoops you have to go through in addition to the move near the Mayo Clinic to get on a Phase I trial?
As for Enhertu, since it's FDA approved you should be able to access it off label. I was offered both Enhertu and Trodelvy and neither was approved for ER+ disease. I also took Keytruda off label but that didn't work for me.
Hugs, Susan
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Susan...I must have not posted well...I would of course stay on Trodelvy if no real SE's and its working...I want to go to measles trial if its not or SE's become to hard...I should know more in 3 days (when SEs expected to hit)
Yes the measles trial only does 1 tumor but they say if it works it should our immune system should attack the rest of them.
Anyone know about
leronlimab it was trying to get FDA approval and all trials look completed...last update about FDA was Nov 2021.
Susan..also what do you mean I could get Enhertu off lable? even JFL had to pay for it and she was actually her2low...Im TNBC so I don't think I can get insurance to cover it?
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Nicole, As we discussed above, leronlimab filed for "breakthrough therapy" designation, which would expedite future trials. They are not close to being available in the clinic.
There is availability in the clinical trial, where it is provided in combination with chemo/ADC
https://clinicaltrials.gov/ct2/show/NCT04313075PDL1-positive cancers are not eligible because they can use chemo-atezo (immunotherapy)
It appears that once the trial confirms that your cancer has CCR5 expression (10% or more), as the vast majority of MTNBCs do, they submit it to their tumor board for approval and the leronlimab is sent to your doctor.
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Nicole,
Thanks for the clarification. Hope Trodelvy works for you for a long time. My insurance paid for both Trodelvy and Keytruda off label. I was on Blue Shield when I got Keytruda and I was first on Blue Shield and then Cigna when I was on Trodelvy. Both are only approved for TN.
Hugs, Susan
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Good short list of promising new treatments:
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For TNBC...show promise...looks like already in trials...
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HI everyone,
I'll be starting olaparib/Lynparza next week. Has anyone else had experience with it?
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Star- I responded to your post in the Lynparza Thread, but wondering what response you would get here. I started Lynparza in September. Seems not many on it. PatgMc just started another newer PARP, but she has not posted much about her experience.
Anyone else out there on Lynparza??
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Merry Christmas to all, 2022 will be here in a flash!!!
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Merry Christmas to all!
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Thank you, candy.
Happy holidays, all!
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Thank you Cure-ious!!! That was really cool!!
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Curious, that card cheered me..actually brought out some laughing tears. And that toe tapping Santa, funny.
To all who are suffering from unknowns, new trials, new chemo, questionable scans, elevated labs..my heart is with you. We made it 2022..well, very soon
Love, S
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Cure-ious,
LOL! Love it! Thanks for sharing.
Hugs, Susan
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Susan, Best of Luck, and all that is Great, in your upcoming clinical trial!! Now they know the Her2-specific ADCs even work on some cancers where the Her2 is very low, so maybe everybody will be taking this drug one day!! Please let us know the blow-by-blow...
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Thanks Cure-ious! Right now I'm focused on how to stay clear of Omicron so I can get on the trial. Despite daily rapid testing and quarantining when he was up here, our son tested positive four days after returning to LA. No symptoms as of yet. One of his roomates brought it in.
Will definitely post frequently about the trial.
Hugs, Susan
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I'm excited about a new clinical trial that just opened last summer! Its one of those rare situations where you read an exciting report and they promise to move it to clinical trials, and they go out and make a start up company and here it is!!!
Some will remember we discussed the paper when it came out in Nature in 2020. It involved creating a customized cytokine that activates the IL-18 surface receptor on T cells and Natural Killer cells and strongly activates both the adaptive and innate immune system to kill cancer cells. It had been a long-standing puzzle as to why the natural IL-18 cytokine had no effect on cancer in clinical trials- until a group at Yale discovered that many cancers pump out a "decoy" protein that binds up the IL-18 in the tumor microenvironment, so it gets trapped there and can't get at the immune cells. The "decoy" binds IL-18 about 10,000x tighter than the natural receptor does, so it is a very effective sink for IL-18. To overcome the problem, they screened a ton of IL18 variants, and were able to identify one that binds to the normal IL18 receptor protein on the immune cells about a million times better than to the "decoy" protein, so this decoy-resistant form of IL18 is able to strongly activate the immune system (both T cells and Natural Killer cells) to destroy the cancer.
From a review: "the decoy-resistant IL-18 had potent single-agent activity that inhibited tumor growth and even produced complete tumor regression in many animals, including in tumor types that are refractory to checkpoint inhibitors" and "The engineered IL-18 acted on a crucial population of "stem-like" T cells within tumors, increasing their numbers over tenfold and skewing their development toward a highly active effector phenotype, as opposed to an exhausted or dysfunctional state. In checkpoint-resistant tumors, the engineered IL-18 also acted on innate NK cells, increasing their numbers and maturation to promote antitumor activity."The group at Yale who discovered the drug started up their own company (Simcha) to bring it to trials, and so this is a phase 1/2 trial; the phase 1a part will identify the best dose to use, and then the phase 2 part will test for efficacy in several different cancers, which includes 25 people with metastatic triple negative breast cancer. Right now there are only two sites for the trial, MGH in Boston and HonorHealth in Scottsdale, AZ..
If successful, this could work on all types of breast cancer and many other cancers. And of course the idea is that it could be the secret sauce that makes immunotherapy work on most cancers.
Here is a link to the trial:
https://clinicaltrials.gov/ct2/show/NCT04787042#el...
And news releases explaining the discovery:
https://www.fiercebiotech.com/biotech/simcha-debut...
https://www.businesswire.com/news/home/20200624005...
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Cure-ious,
If I am reading the clinical trial description correctly, this isn't just open to trip neg BC patients, but those who are MSI- High or TMB-High. Am I missing something, or is that what the description says? It sounds very much to me like the description of when keytruda can be used as a mono therapy for any solid tumor, including all kinds of breast cancers.
This sounds very exciting.
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