Are you currently (or have you been) in a Clinical Trial?
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BevJen, Ah, you are quite right, great catch! This trial casts a wide net and includes those whose cancers express a lot of mutant neoantigens, like MSH-hi and TMB-hi. Its a first-in-human, so hopefully no awful side effects and that they get the dose right. Because it binds so tightly to the IL-18 receptor they won't need to give patients much of it, which means fewer off-target effects or collateral damage, so otherwise we just have to hope there is no down-side to stimulating the IL18 receptors in cells in the gut or organs beyond the immune system.
For checkpoint immunotherapy to work really well, you ideally need two things:1) for the cancer to express lots of neoantigens (mutant proteins stuck on its surface) and 2) to disable the immune cells that hide the cancer and activate the TILs; this drug can do the latter so the possible upside is really exciting. The paper showed it works in some cancer cells that do not respond to checkpoint inhibitors as well
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Here is another clinical trial seeking to make immunotherapy work for MBC:
https://clinicaltrials.gov/ct2/show/study/NCT04691...
This trial is open to several specified cancer types, which includes ER+Her2- MBC and mTNBC.
They are testing PY314, a monoclonal antibody directed to TREM2, which was just recently shown to mark pro-tumor macrophages that block immune cells in the tumor microenvironment for certain cancers, and strongly implicated as one of the reasons immunotherapy does not work for MBC. The PY314 antibody kills these tumor-protective macrophages and enables T cells to infiltrate the tumor and kill the cancer cells. The trial is a large phase 1 (designed for 276 patients), and will test PY314 alone, and in combination with Keytruda.
Hopefully this is an important breakthrough for immunotherapy- it is based on two papers that appeared in CELL in 2020, so they are moving it fast.
https://www.nature.com/articles/s41392-020-00356-8
Eligible for breast cancers [TNBC and HR+ HER-2-] with metastatic disease that is relapsed or refractory to at least one line of metastatic therapy, and they are looking for people who progressed on a checkpoint inhibitor alone..
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There is a new Phase 2 trial that will combine Enobosarm (AR booster) with Verzenio (CDK4,6 inhibitor). The listing is from Nov 2021 but not at the recruiting stage quite yet, so we don't know the locations.
https://clinicaltrials.gov/ct2/show/NCT050654110 -
Curious - That link is to Verzenio and Bicalutamide combo trial. Bicalutamide would be almost the opposite of enobosarm, in that it appears to be an androgen antagonist (blocker).
Maybe this is the trial you were referring to?
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Cure-ious,
In reading through the PY314 clinical trial site, it lists under Exclusion Criterion, "Stable treated or asymptomatic brain metastases for at least 3 months documented by brain imaging prior to enrollment." Shouldn't it be the opposite? You should be excluded if your brain metastases are not stable or asymptomatic for at least 3 months.
Is my logical backwards?
Hugs, Susan
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Susan,
I’ll be interested to see what Cure-ious has to say as I agree, that seems pretty wonky. I spent yesterday perusing the Canadian clinical trial sites and noticed many excluded patients with active brain mets. It was reassuring to see that I still qualify for a few as long as I can keep my ECOG status up there.
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Whoops!- Many thanks, Husband, for picking that up!! I'm going along too fast; will edit my original link and put the right one in there...
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Susan, I read that line about brain mets three times and still couldn't figure it out, would be best to just ask them. As you know, most trials say they are fine with brain mets so long as they have been treated and are currently stable. Perhaps the sentence was meant to be in the Inclusion Category, instead of the Exclusion Category, then it would make sense, saying brain mets have to have been stable for at least 3 months....
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For the PY314 anti-TREM2 trial, here is a youtube clip from the company explaining the rationale for the clinical trial. TREM2 is found on tumor associated macrophages (TAMs) that are immunosuppressive, and the antibody kills off these cells allowing CD8+ T cells to invade the tumor. They are recruiting in several solid cancer types for individuals who do not respond to checkpoint inhibitors to see if addition of PY314 makes a big difference, and, if so, to determine whether TREM2 expression levels are a good biomarker for response.
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Made it onto the ARX-788 trial. Getting my first dosage tomorrow! I have to be there for over eight hours because they need to monitor me before and after the infusion. A little nervous but mostly excited!
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Good Luck Susan- thinking of you! Nina
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Susan, wow, congratulations, please keep us informed. Saulius
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good luck Susan.
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Great news Susan. So happy for you. May you pave the way for the future!
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Well done Susan and the very best of luck
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Awesome Susan! Best Wishes!!!
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So wonderful to hear the great news Susan!
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Thanks to everyone for the support! Hopefully, ARX-788 will get approved!
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Fabulous news Susan. And they sure don't wait around!
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Good luck Susan! Please keep us up to date on how it goes. cheers, dee
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Very exciting, Susan, and may you will be one of the stats based on which ARX-788 approval gets granted!
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Dee, how long have you been on Tomivosertib? I saw a study for lung cancer where it was given together with immunotherapy for lung cancer patients who had progressed on immunotherapy, and 41% of those patients responded for at least six months, it sounds promising from both anti-cancer and immune system activities..
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So got my first ARX788 infusion this morning. Showed up at 7:15am for my 7:30am appointment. Apparently the pharmacy doesn't even open until 8am and then they have to unthaw the medicine so I had to wait three hours before starting the infusion. Premeds were Tylenol and Benadryl. Blood samples and vitals taken multiple times including six hours after the infusion started so I wasn't out of there until 3:20pm. Interestingly, at USC they have a special area just for trial infusions. So I had a room to myself with a bed and two nurses taking care of me. At first, I was kind of bummed that the rooms were very dated with low ceilings and no views out the window from the bed. I'm spoiled because the infusion center at UCSF has lots of windows and natural light. I think I was stressed out to be in a completely unknown setting because I felt like a grouchy baby inside.
I was told I didn't have to bring food because my meals would be delivered. That's nice. The breakfast was all white food, a bad white-flour bagel, a banana, yogurt (I don't eat dairy). Luckily, the nurse was able to snag me a small bowl of scrambled eggs. The grouchy baby in me was very hungry and needed protein. Lunch was actually pretty tasty and nutritious. The day went by quicker than I thought and the nurses were all very nice and skilled.
Post infusion, I'm a bit fatigued from sitting for so long but I generally feel like my normal fatigued self. Since eye toxicity is one of the side effects of this drug, I have to use eye drops every couple of hours. For the next 24 hours, I have to collect all of my urine in a plastic bottle and keep it cold.
They are also letting me go after my day 4 labs! I thought I had to stay down here for three weeks but they are waiving the day 8 and 15 labs. It's been tough living in a hotel room with my husband and dog. The hospital is in a food desert so we have to drive to get anything to eat. No grocery stores, no restaurants, just one Panda Express for the entire medical and residential complex! So weird.
The main thing is, I got the drug!
Hugs, Susan
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Susan- so happy for you! It is great that you get to go home on day 4! how often are the infusions?
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Susan, I hope they get their act together for future, but being in so many trials, I know they have many more hoops to just through. So happy that you got the drug, now it just needs to work!!
Cure-ious, I'm starting cycle 10 of tomi on Monday, so 40 weeks so far. fingers crossed for all of us! cheers, dee
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Nkb,
The infusions are once every four weeks. This syncs well with my monthly appointments with my Chinese Traditional Medicine doctor down here. We can also visit with the kiddos who both live in LA.
Dee,
Congrats on being on tomi for so long! Wishing you many more successful cycles going forward!
Hugs, Susan
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Susan, I'm just smiling at the picture of a SF foodie trying to deal with an older USC hospital with crap food!!!! Better pack lotsa snacks for next time...
Dee, I'm really getting excited for tomivosertib, can you tell what the side effects are, given how many are coming from the abraxane/chemo?
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Cure-ious,
B'cuz I was changed from paclitaxol to Abraxane, I can tell you most of the SE's from tomi. I developed a rash about cycle 2 or 3, so that's when my MO dose reduced me to 50%, one pill per day instead of two. Both of the drugs show SOB & I think they both contribute equally as I was off chemo for a month & the SOB improved somewhat but she has now put me on 2mg dexamethasone which is helping alot, sleep is affected by it but I am taking .5 of ativan.
So now that the SOB is being taken care of, the worst SE is from Abraxane & that it is the neuropathy in my feet. Because I have to travel so far for the trial it is very difficult for me to take ice socks with me as they just don't stay cold, tho I am going to try to take a large ice pack & just put my feet directly on that & see if it helps at all.
Some very minor other SE's are hand shaking which is from tomi, a bit of nausea on chemo day & the next from chemo. These are both very minor.
I hope the trial works out as (fingers crossed) it seems to be working for me at the moment. cheers, dee
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Cure-ious,
LOL! I can honestly say that I was more stressed about the bad breakfast than I was about starting the new drug.
Hugs, Susan
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too funny Susan! I love how our priorities change. Good thoughts for the trial to work well for you with minimal SE’s
Cheers dee
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