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Elacestrant (ORSERDU)

jsniffs
jsniffs Member Posts: 136

Starting this topic to share info about the new medication elacestrant.

Elacestrant (ORSERDU) was recently FDA approved for ER+/HER2- MBC for patients with the ESR1 mutation. Just before it was FDA approved, I was able to obtain the drug through an expanded access program (thanks to WeninWI for the info!). The expanded access program required a lot of sign-offs and steps. Hopefully, now that it has been FDA approved, elacestrant is easier to obtain.

I'm currently taking the 400 mg dose daily. I think this is actually the same as the prescribed "350 mg" dose. It is a large-ish bright blue tablet. Thus far, I've mainly had a minor altered taste in my mouth (although it seems to have lessened a bit) and possibly minor joint pain in my hands and feet. I was prepared for more significant nausea and not wanting to eat, but I've had the opposite effect. I have been eating more to try to mask the weird taste, but food tastes fine.

I'd love to hear from others who have taken or who might be starting elacestrant.

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Comments

  • jsniffs
    jsniffs Member Posts: 136

    Interesting article on the history of elacestrant: https://www.newsobserver.com/news/local/article272...

    Regarding the quote, "as Wardell likes to think of it: "three out of 10 grandmothers that got to go to graduation."

    Sheesh! They may need to expand their thinking of who they may be helping. I'm a 43 year old mother of a 6 year old. So glad they stuck with this.

  • nkb
    nkb Member Posts: 1,561

    Good luck with this drug! I am very interested in how you do with it. Are you taking it with another drug like a CDK4/6 inhibitor or by itself?

    I don't have an ESR1 mutation, but, am very interested in an oral SERD or PROTAC since I may be resistant to AIs-

  • jsniffs
    jsniffs Member Posts: 136

    Thanks nkb! I'm taking it by itself as my main treatment (also on Lupron and Xgeva).

  • weninwi
    weninwi Member Posts: 747

    jsniffs,

    Do you take Lupron for MBC? I read that it is used to treat endometriosis and prostrate cancer.

    I read the article that you posted. Interesting background info on the development of Elacestrant. Curious there is no mention of the Menarini Pharmaceutical Group, but really not so important to patients. Nkb asks an interesting question....if Elacestrant was ordered alone or with a CDK4/6 inhibitor. It will be interesting to see how it gets prescribed for more patients with the ESR1 mutation. I had another second opinion visit with my Mayo doctor (who I really like) and she said she does not yet have any patients who need Elacestrant (ORSERDU). She added that lipids need to be monitored while on the drug. When will you know more about how the drug is working for you?

    Wendy

  • jsniffs
    jsniffs Member Posts: 136

    Hi Wendy - Yes, the Lupron is related to MBC. I take Lupron for ovarian suppression since I'm pre-menopausal, and my ER/PR receptor percentages are generally >90%.

    It is interesting to see what will happen with Elacestrant and other meds. My MO wanted to stick with it as a monotherapy since that is what the study did. I had a 2nd opinion MO who seemed fine with possibly adding a CDK4/6 since it has a similar mechanism as Fulvestrant. For now, I'm just going to do a monotherapy. Other clinical trials are in the works for various combos of Elacestrant with other, what I like to call, "turbo boosters." :)

    Yes, lipids do need to be monitored. I also had to do an ECG, although I'm not sure if that is standard or just something I am doing because I received the drug through the expanded access program. I have labs in a couple of weeks, so those may show some indication that things are working, although it may be too soon. I'm guessing, I will have a better idea during month 2-3. I also have skin mets that could possibly show something. Tests say those mets have lost their ER/PR receptors completely, which seems quite suspicious. I got the feeling that both MOs seemed to think that was questionable. I mean, how do you go from almost 100% to 0% (absolutely nothing) both in ER and PR? Seems weird. Therefore, before trying to do any local treatment, we may monitor to see if the skin mets are helped by Elacestrant after all.

  • tarheelmichelle
    tarheelmichelle Member Posts: 248

    Is anyone taking elacestrant who doesn't have the mutation? My MO and I have been waiting for approval for years, and I only recently saw the mutation requirement. I didn't have the mutation in 2021 but my oncologist insists that could change so we are testing again. I've read that this particular mutation is associated with worse survival, so haha,I'm not sure if I really want it to appear.

  • weninwi
    weninwi Member Posts: 747

    Upcoming conference of interest:

    CURE Educated Patient Breast Cancer Summit - Saturday, March 3, 2023 - Miami Beach, Florida

    https://event.curetoday.com/event/21791689-6969-4b...

    It's free - you can attend either in person or virtually. To register for virtual attendance scroll down the main page a bit until you see the Register for Virtual. Looks like an interesting agenda, and what caught my eye was the Keynote Presentation 10:05 am - 10:30 am ET and the last item on the agenda - Fireside Chat and Q & A session 4:00pm - 5:00pm ET....."A new era in the treatment of MBC: targeting ESR1 mutations".

    Wendy

  • jsniffs
    jsniffs Member Posts: 136

    Thanks Wendy for sharing info about what you did for an itchy scalp. I have dropped shampoo use to every so often (maybe once a week), and I mostly just use the apple cider vinegar rinse every few days. For now, that seems to make things manageable.

    Here is my one month update on Elacestrant:

    • Complete blood counts and comprehensive metabolic panel look the best they have in a while - pretty much all normal
    • Alkaline phosphatase (often a bone mets marker for me) dropped about 20 points back into normal range
    • CA.27.29 looks like it might be stabilizing (?), not a significant change from 2 months ago (was 88, now 91)
    • Lipids have changed - I had a 20 point increase in overall cholesterol, although the individual components seem to still be in a normal range
    • EKGs and Echo - normal
    • Side effects - minor to almost non-existent nausea (seems to get better every day), itchy scalp at night, possibly some fatigue (hard to tell as my sleep isn't always as long as I'd like, but Elacestrant doesn't seem to cause middle-of-the-night crazy insomnia like I've had in the past)




  • malebreastc
    malebreastc Member Posts: 87

    is this a replacement of Fulvestrant ?

  • weninwi
    weninwi Member Posts: 747

    malebreastc,

    Elacestrant is a SERD (Oral Selective Estrogen Receptor Degrader) and was given FDA approval only for patients with the ESR1 mutation. The ESR1 mutation makes the tumor unresponsive or resistant to hormone therapy (my simplistic understanding). I believe in the clinical trial (Emerald Trial), those patients with the ESR1 mutation did better than those without the mutation, thus the FDA decision. I understand Fulvestrant to be in the hormone category, so I would say "yes" to your question. There are other oral SERDS being studied, Lasofoxifene being one, that would also replace Fulvestrant, at least as understand it.

  • jsniffs
    jsniffs Member Posts: 136

    malebreastc - I believe this could be a replacement for Fulvestrant, especially for those with the ESR1 mutation. It will be interesting to see how the use of this drug evolves. Since Elacestrant wasn't available until recently, I had already used Fulvestrant. Therefore, I'm using Elacestrant as a third line treatment. There is not a ton of data to back this up, but I did fit the criteria for the expanded access program from the company (I do have the ESR1 mutation). Therefore, I'm willing to give it a try.

  • malebreastc
    malebreastc Member Posts: 87

    Thanks for the response, I don’t have the ESR1 mutation so might have to continue Fulvestrant till it works, the hassle is the monthly inj

  • bookgal
    bookgal Member Posts: 20

    I'm not on this drug yet but was tested for ESR1. Just got back my Guardant results and it does show a ESR1 mutation. Did you have this test done? Do you know if you have to have a certain % of the ESR1 mutation to be eligible or for it to be effective. I have not heard back yet from my Drs office (that could take a while) and am interested in what others are doing,

  • weninwi
    weninwi Member Posts: 747

    bookgal,

    I had a STRATA genomic test that showed ESR1 mutation at 30%. Neither my primary MO nor my second opinion Mayo MO have said anything about needing to have a certain qualifying % for treatment with Elacestrant. The FDA has determined that Elacestrant is only authorized for persons with the ESR1 mutation.

    Oral SERDs like Elacestrant was a focus of CURE's Educated Patient summit held Mar 3 in Miami. I attended virtually and do not remember hearing anything about needing a certain qualifying % of the ESR1 mutation to be eligible for Elacestrant treatment.

    The summit will be posted at https://www.curetoday.com/summits-on-demand for viewing, but I just checked and it is not up yet. The opening keynote presentation was: "A new era in the treatment of MBC: targeting ESR1 mutations". The entire summit was very good and covered much more than just ESR1 mutations and oral SERDs like Elacestrant.

    I've read that after treatment with Elacestrant the ESR1 mutation can disappear, but I do not know how true this is. If it is accurate, it might suggest that hormone treatments would be back on the table for treatment options.

  • jsniffs
    jsniffs Member Posts: 136

    Hi bookgal - I'm not aware of a particular threshold for ESR1 either. Note, Elacestrant seemed to be at least somewhat effective for both people with and without the ESR1 mutation. I would not be surprised to see the eligibility for Elacestrant expand as more study data become available (especially if and when it is taken with other meds). For reference, my % was almost 60% for the ESR1 mutation. I used the Foundation One test (because I did the test before the FDA released the approval for the Guardant test).

  • bookgal
    bookgal Member Posts: 20

    jsniffs and weninwi - Thank you both and so much for your response. I have heard nothing from my oncology team yet. I suppose I will have to contact them again to ask. My mutation percentages were all less than 10%, So I thought that perhaps that meant the treatments/trials would not be an option for me. Good to hear it's still a possibility.


    Weninwi- Thank you for the info about the webinar. I believe I followed a link you had posted some time ago to a different webinar/topic (sorry, I can't remember which it was right now) but I learned quite a bit. I appreciate you sharing them. I will remember to take a look to see when it is posted. Thank you :)

  • weninwi
    weninwi Member Posts: 747

    I've wondered if treatment with Elacestrant can result in the disappearance of the ESR1 mutation. I decided to pose the question on the website of the Menarini pharmaceutical company that developed the drug. This is the answer I got:

    "Thank you for your inquiry and interest in Elacestrant."

    "In response to your question" - Have studies on Elacestrant shown that for patients with the ESR1 mutation, the ESR1 mutation disappears or is no longer found (based on testing) after taking Elacestrant?

    "Elacestrant blocks the estrogen receptor as well as the ESR1-mutated estrogen receptor and leads to its degradation, or a breakdown. To date, monitoring the disappearance of the ESR1-mutated estrogen receptor has not been conducted, therefore, there is no data."

    _______________BSN, RN.......Executive Director Patient Advocacy and Professional Relations

  • weninwi
    weninwi Member Posts: 747
    edited March 2023

    The Cure Educated Patient Breast Cancer Summits-on-Demand for the Mar 4, 2023 summit held in Miami is now up for viewing: https://www.curetoday.com/summits-on-demand

    Unfortunately the Keynote presentation that focused on Elacestrant is not included. I emailed Cure to ask if could be posted.

    I've been confused about different median progression free survival (PFS) numbers for patients with the ESR1 mutation from the Emerald study. In some instances I read 3.8 months for the Elacestrant arm vs 1.9 months in the fulvestrant or aromatase inhibitor arm. But I just listened to a discussion between Hope Rugo MD and Joyce O'Shaughnessy MD where they say the Emerald study showed the longer a patient has been on a CDK4/6 inhibitor prior to Elacestrant the better their PFS.....if "more than 12 months on CDK4/6, they were up to 8.6 months median PFS verse endocrine therapy, so nice improvement".

    https://www.medpagetoday.com/meetingcoverage/sabcs...


  • nkb
    nkb Member Posts: 1,561
    edited March 2023

    Weniwi- I heard that statistic also re previous CDK4/6 users

  • gigil
    gigil Member Posts: 896
    edited March 2023

    I read that also regarding previous CDK4/6 users. My question is when does one get tested for these mutations? No oncologist I have seen even suggests thst sort of testing and it seems it would be so helpful in choosing a direction for trestment

  • weninwi
    weninwi Member Posts: 747
    edited March 2023

    gigil,

    I'm not sure about the timing of when to get tested for mutations, but from my reading there are two methods for testing. 1.) a liquid biopsy which is a blood test. It has advantages (ease of getting a sample) and limitations (something to do with the quality of the information provided) and it's a newer test so not every cancer center offers it. I think there is info on liquid biopsy on this site under the "Learn" tab. The other method is 2.) a solid tissue biopsy, like from liver or bone. From my reading it's considered the gold standard, but the tumor has to be big enough to get a sample and in a location that can be reached, and the procedure carries risk. I think your question is a good one to pose to your MO. If you ask, let us know what you're told.

  • jsniffs
    jsniffs Member Posts: 136
    edited March 2023

    Hi gigil - Generally, tumor genetic testing is done when it might make a difference in treatment. For first line treatment, tumor genetic testing is not often done. However, when you get to 2nd, and especially 3rd lines of treatment, tumor genetics may drive your treatment plan. One thing to note, the ESR1 mutation is usually driven by the use of aromatase inhibitors. It would be rare to have the ESR1 mutation from the start.

  • jsniffs
    jsniffs Member Posts: 136
    edited March 2023

    cure-ious - Thanks for chiming in with extra detail. Do you know which studies have shown the ESR1 mutation to become undetectable with SERD treatment? I think weninwi had contacted Menarini (manufacturer of Elacestrant), and they didn't have any data on this. I would love to know, as getting rid of the ESR1 mutation might open up more options again. :) Thanks!

  • saltylibrarian
    saltylibrarian Member Posts: 1
    edited April 2023

    hi all, I just leaned about disease progression to my liver. Prior was bone Mets only. Ibrance for a year, Verzenio for 16 months. Ers1 mutation found and I’m likely starting today or tomorrow. I meet with my Oncologist today and meds arrived Monday (two days ago). I will be sharing here because I hope it will be helpful to others in their journeys. Im hoping to get longer than 3-6 months out of this drug but we truly never know what our outcomes will be with this disease. I also joined the Facebook group specific to this drug. Let’s hope for us all!

  • jsniffs
    jsniffs Member Posts: 136
    edited April 2023

    Thank you saltylibrarian for joining us and being willing to share. Sorry to hear about the progression. Best of luck with starting Elacestrant/ORSERDU. I've found it pretty tolerable. I haven't been on Verzenio, but I've found Elacestrant way better than Ibrance (especially in terms of fatigue). Are you going to be taking it with anything else?

  • ddil
    ddil Member Posts: 92
    edited April 2023

    HI All,

    I discovered the ESR1 late December 2022. Started Kisquali and Faslodex in January. Minor progression to T9 had radiation. My markers keep climbing my 15-3 is now 154. I just did the Guardant360dx and will more than likely switch to Orserdu. I’m stressing a bit since I was only diagnosed 1/2022 and went through Ibrance and Letrozole, and now Kisquali and faslodex. I was told that the ESR1 can go away per Mayo, not just from the meds but in general it can go away or comeback once gone.

    I was thankful to find out quickly about this mutation. Also, testing for mutations before medication switch to me seems to be more accurate in determining the right meds.

    Have any of you found a med that lasted awhile for your ESR1

  • weninwi
    weninwi Member Posts: 747
    edited April 2023

    saltylibrarian and ddil,

    According to Hope Rugo MD (and Joyce O'Shaughnessy MD), the Emerald study showed the longer a patient has been on a CDK4/6 inhibitor prior to Elacestrant the better their PFS.....if "more than 12 months on CDK4/6, they were up to 8.6 months median PFS verse endocrine therapy, so nice improvement". https://www.medpagetoday.com/meetingcoverage/sabcs...

    Please, keep us posted on how you do on the drug. I'm still on Xeloda, but expect Elacestrant will be in my future.


  • emac877
    emac877 Member Posts: 652
    edited April 2023

    I read through this thread after a discussion today with my MO. He is looking into this drug as an option for me as I have had a horrible time with Fulvestrant injections. I'm not sure I will qualify though. I don't know if I have the ESR1 mutation and I have been on Verzenio/Fulvestsrant for 3 years without progression. It sounds like I may not meet the FDA specifications for Elacestrant. Has anyone here been prescribed Elacestrant without meeting one of those two qualifications?

  • weninwi
    weninwi Member Posts: 747
    edited April 2023

    emac877,

    As I understand it, approximately 20-40% of patients who have received an aromatize inhibitor (AI) develop the ESR1 mutation. I do not know if other treatments may also contribute to this mutation. If you have ever been on an AI I would definitely suggest asking for a genomic test. I found this regarding the test: "The FDA has approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for patients with advanced or metastatic breast cancer harboring ESR1 mutations who may derive benefit from treatment with elacestrant (Orserdu)."

  • emac877
    emac877 Member Posts: 652
    edited April 2023

    Thank you. I will ask my MO about genetic testing. I have primarily been on Fulvestrant and Verzenio as my first line treatment and only briefly tried exemestane.