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Just started immunotherapy trial (neoadjuvant Xaluritamig)
Hello. I haven’t seen any posts in forums about Xaluritamig clinical trial participants so figured I’d share in case there are folks out there who may be considering or who are/were in it to share their experience.
My story: 53yrs. Diagnosed in January after having elevated PSA (~7) found due to suspected Prostatitis. CT clear at the time. PSA went down to ~6, so seemed OK. But a year later, it only went down .2 or so. DRE was suspect, so MRI done. PI-RADS 5. Biopsy was Gleason 9 (4+5 w/ cribriform and PNI). PSMA-PET was somewhat equivocable for rib metasticies, but otherwise prostate contained. Got connected to multidisciplinary prostate cancer team at Fred Hutch in Seattle for a second opinion. They felt that the tiny rib legions were likely from prior injuries and were indifferent about surgery vs. radiation, but all felt a clinical trial would be best due to the high risk of future recurrence (50-80% in 10 years was shared). Two studies were available given my risk profile and both ended in RP. It was a tough decision, but Xaluritamig seemed to have very promising resulting in late stage cancer and using in advance of surgery is similarly promising. The drug is also called Amgen 509 and the study is Amgen NEO. It’s an immunotherapy that targets STEAP-1 cells by training T-Cells to fight it - forgive any layman’s mistakes but details are online.
The study combines Xaluritamig with ADT (Orgovyx), the later of which I’ve been on for a month. Beside poor sleep, zero libido, mild hot flashes (annoying but not sweat drenching), and a bit more easy to tire when exercising, no other ADT symptoms to speak of which is awesome. I realize that those things all sound objectively terrible in almost any other context.
Today was my first infusion of the immunotherapy, which starts with a tiny dose, increasing each week for two more weeks for Cycle 1, then two more treatments in Cycle 2, then RALP about 2 weeks later (ADT stops then). Nice thing about the study is it pays for a post-treatment MRI, so if 3 months of ADT plus the Xal shrinks things a lot, it will help with surgical plans.
3 hours post-infusion I have no side effects from it, but certainly will expect flu-like symptoms at some point, maybe not until next week though. I have a veritable pharmacy of meds to manage potential symptoms. They give steroids (dexamethasone) to calm the immune system and preemptive Tylenol. Then I have drugs for muscle pain, diarrhea, and nausea as needed. Joining a trial has added a ton of visits, tests, and blood draws to what could have been a straightforward treatment plan. My MyChart periodically explodes with test results and appointments check-ins (6 appts today and around 8 or 9 tests). I took two special trips to Seattle to enroll and will take a total of 6 more in-person plus roughly biannual visits for 3 years. Luckily Amgen pays for travel expenses up to a very reasonable amount, and that includes my wife.
So, all in all, it feels really good to finally be in this part of the study and be feeling well enough to write this while waiting for the Day 1 observation period to be over.
Curious if anyone else is in this trial and happy to share more as this progresses if folks are interested.
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Just stopping by to thank you for sharing information about this interesting trial and to wish you 100% success 👍🍀 !!!
How exciting : ))). Imagine if this proves to be real cure for PC ! Oh how wonderful it would be ...
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3 ReactionsCongratulations on getting into the trial, and I hope you have positive results from the treatments! I hadn't heard about Xaluritamig and am glad to hear there are immunotherapys under investigation - thank you for sharing.
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2 ReactionsRay here. Thankyou for the input. I appreciate you taking the time to write.
This may be helpful for a number of folks unaware of this trial.
Best to you and your wife.
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1 ReactionOne of the guys who was at the ancan.org Advanced prostate cancer meeting last night, said that he was in that trial, but they were not gonna give them the drug they were going to give him Cabazitaxel and he would not get the steap1 drug. He’s already had 10 sessions of chemo with docetaxel, And he’s had Pluvicto He was worried that he didn’t want another chemo drug.
Well, there are almost always two sides to these trials.
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2 ReactionsHey, sounds promising wish you and your family the best. Yes very interested in your treatment. Thanks for taking the time to let everyone know. God Bless
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1 ReactionWish you the best.
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1 ReactionInteresting study and kudos to you for enrolling in it. I think it’s a win/win for you because even if the immunotherapy drug doesn’t work - which they really won’t know for a few years at least - the Orgovyx will halt your cancer in it’s tracks and probably shrink the gland down quite a bit.
Surgery will definitely be more precise on a more well defined gland and the marginal areas will be able to be examined in better detail.
And of course, if your T cells DO learn to respond to PCa cells, you will hopefully never suffer BCR🤞🤞. Best,
Phil
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2 ReactionsWe’re considering the phase 3 study of this drug. How did it go for you? Are you still on it?
@charly55 Short story is that it all went pretty much as planned, but was more like a chemo experience than I had hoped.
I had 5 total infusions and got my RALP two weeks after the last one. The first two infusions were low doses and I had basically no side effects. I was wondering if my immune system was reacting at all. That question was solved after my first full dose when I spiked a fever the evening of the infusion. Careful what you wish for and all that. Fever was nothing crazy - 101, but above the threshold to call the nurse hotline, so it was off to the ED for me since they take cytokine release syndrome very seriously. All tests were fine and fever resolved pretty quickly with some additional dexamethasone (steroid and immune suppressant), but they wanted me to stay another night. Not the end of the world but these are the same challenges with the drug in its first trial and its no fun to get even more IVs, tests, etc. I thought I'd be in the clear after 4th infusion, thinking my body was getting used to it, but 3 days after the infusion, I got a another fever. Same story as before ED in the evening plus another night for monitoring. Last infusion didn't need ED, but they kept me taking dexamethasone for the infusion, which is an optional thing because it offsets the effectiveness of the immunotherapy.
So besides the risk of hospitalization, I got quite a bit of fatigue and lost a ton of fitness, although it's hard to say how much was the Orgovyx vs the study drug. And it was hard to sleep. That was probably due to the dexamethasone which, I ended up calling my "meth" since it seemed to amp me up. The dex also spiked my blood sugars a lot which was mostly OK but might be a concern for diabetics. I also got anemia, but not to the point where they wanted to treat it. PSA went from around 7 to .2, but again, most likely from ADT mostly. So, all that said, Xaluritamig wasn't the easiest but I knew the main risks due to seeing the first Phase 1 trial results, and the negative impacts all seem to be transient.
The study included a post-infusion MRI prior to RALP and that showed markedly smaller tumors - to the point where I went from PI-RADS 5 to not even qualifying for that scale. Caveat is that I was also on ADT starting a month before the Xaluritamig and it is known to have that effect. But, margins and nodes were all clear, which is great for my gleason 9, PNI, and ECE. Post-surgical biopsy showed confirmed PNI and Gleason 4 with cribriform and Stage T3a. My original biopsy showed some Gleason 5 too, but doc said after ADT, everything looks like gleason 5, so they don't call anything 5.
Now 6 weeks out from surgery, first PSA was <0.1 and bodily functions are recovering nicely. I did the study in hopes of preventing BCR years down the road, so the jury is out for me. I think massive success for Xaluritamig would have been for the prostate to show no viable cancer, but that would have been pretty much magic with a solid tumor and a couple months of treatment. What I do know is that my immune system reacted strongly. What I hope is that I never get BCR, but like many here, will have to watch and wait.
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8 Reactions@zerostarhobby so you are part of a study that used this PRE surgery, right?
Any particular factor in your pathology call for this, rather than just Orgovyx alone?
I wonder if Joe Biden has been given this seeing how he is now metastatic castrate resistant…
Good luck going
Forward..,
Phil