Darolutamide

[Finlay66]

I stumbled across this on what would appear to be positive news.

england.nhs.uk/2022/11/nhs-...

I wondered if anyone had experience of this drug including use in the UK?

[6357axbz]

seems promising

[Benkaymel]

Thanks, a positive move but AFAIK, it'll only be offered to newly diagnosed people. I hope I'm wrong!

[Finlay66 in reply to Benkaymel]

Yes you could be right. I have searched the internet in vain to find the conditions in the UK. Most articles are out of date. They may not be different to the terms Tall_ Allen has described below but I can but try.

[Tall_Allen]

That article is poorly written. Darolutamide is so far only used in metastatic patients in combination with chemotherapy and ADT (called "triplet therapy") in PCa patients who are newly diagnosed with metastases.

prostatecancer.news/2021/05...

[KocoPr in reply to Tall_Allen]

TA, do you mean in the UK? The reason i say this is i got daro along with Orgovyx and im CSPC, that has gone through RP, and EBRT. Im in USA.

[Tall_Allen in reply to KocoPr]

Triplet with darolutamide and docetaxel and ADT is approved in the US for newly diagnosed metastatic men, and the article seems to be about the UK following suit. Darolutamide is also approved for non-metastatic CRPC. If you got it for recurrent mHSPC, that is off-label. Sometimes insurance will approve off-label use when an MO makes a good case for it, in the US.

[KocoPr in reply to Tall_Allen]

Thanks TA, that must be my case then.

I do feel fortunate to have the team i do have.

[Survivor86 in reply to Tall_Allen]

Upon the recommendation of my Dana-Farber Cancer Institute MO, off-label use of darolutamide was approved by my insurance (Medicare and BC/BS) for metastatic hormone sensitive prostate cancer after SBRT to upper spine and right femur and taking Xtandi for six months but not tolerating side effects well. By this time my PSA was undetectable and testosterone in single digits. I continued on darolutamide (“Nubeqa”) for 18 months, PSA and T remained at these levels, a and have over the six months since I was given a holiday from both. If your circumstances are similar, its definitely worth discussing with your MO.

[TJS-1 in reply to Survivor86]

Same for me except taking Darolutamide as a monotherapy. So far (7 months) working exceptionally well w/undetectable PSA, T hovering around 700, no progression on PSMA PetCT, and no side effects like I had with ADT. Also had RRP and full pelvic IMRT 8 and 5 yrs ago respectively with intermittent ADT (Firmagon, Lupron Zytiga). Good thing BC/BS is covering this- full invoiced cost from Bayer $24k/mo!

[MateoBeach in reply to TJS-1]

very good to see that it works that well for you as monotherapy. I wondered about that. It should and is less vulnerable to antagonist to agonist switching mutations than bicalutamide.

Seems the FDA and insurance industry are oriented to limit who can get it rather than expanding use of a superior drug.

[Tall_Allen in reply to MateoBeach]

The FDA, with rare exception (e.g., Keytruda for cancer-agnostic MSI-hi/dMMR) is only allowed to approve what has been tested. Insurance is another matter. I'm not sure that darolutamide is superior.

[Gl448 in reply to TJS-1]

7 months without Lipton or the like?

Is this an “ADT HOLIDAY” or NUBEQA as monotherapy some new approved or off-label usage of that drug?

[TJS-1 in reply to Gl448]

I had difficulty with SE’s of first line ADT (Firmagon and Lupron, + Zytiga). We’re using Daro as monotherapy for now, with excellent results in all metrics (Yes, N=1. I’m not newly diagnosed and am HSMPCa. No trials supporting this yet, but insurance is obviously on board).

Watching PSA and blood panels very closely, with periodic Pylarify scans for progression. I’m a VERY physically active/QOL oriented guy, and this protocol has been far superior in every way to ADT and ADT backbone ”SOC” for me - so far, anyway . . . 🙂

[dagreer in reply to TJS-1]

I was wondering about your side effects? I am entering a trial with Darolutamide as a mono therapy. I am still hormone sensitive (theoretically) .

[TJS-1 in reply to dagreer]

For first 6mos had no discernible SEs from Nubeqa and stayed extremely active. By contrast on ADT (Lupron and Firmagon) had severe hot flashes, brain fog and noticeable loss of endurance and strength manifest at 3rd month in. By 6-9 months on ADT also experienced severe joint pain in extremities, weight gain, lost all body hair and a lot of muscle definition and strength. Depression started setting in and got progressively worse through the 1.5 year regimen.

By comparison on Nubeqa (now 9 months in) have experienced only some disappointing muscle/joint pains that are persisting; mostly at sites of prior injuries that never fully rehabbed and are like arthritis symptoms. Seems to be a function of hormonal manipulation from any of these hormone based treatments for me. Manageable with ibuprofen. Have been able to maintain most strength and muscle definition with frequent exercise, which is different and surprising, and no noticeable cognition or memory impairment. No weight gain either. PSA is holding at <.01

SEs I experienced common to both protocols are loss of body hair, loss of libido, and no body odor from sweating (a single silver lining 🙂); plus the joint pains seem milder with Nubeqa than the first line ADT. To be updated in a few months . . .🤞

[dagreer in reply to TJS-1]

Thanks. That sounds very promising...

[Teacherdude72 in reply to TJS-1]

$24K a month? last years medicare cost was $12K and the new medicare cost this year is $13-14K

[TJS-1 in reply to Teacherdude72]

Good to know - not eligible for Medicare yet. $24k is the current Bayer invoice; then my private insurance negotiated discount cost is $12,700 which they have been paying for 120 pills/300mg per month. I guess the $24k is for the uninsured? Was shocked to see these numbers on my Rx insurance summary.

[Ian99 in reply to Tall_Allen]

TA, do you know of any cases where this triplet treatment has been applied to mCRPC patients? It’s not covered in the Uk but may nevertheless be effective, which is why I ask.

[Tall_Allen in reply to Ian99]

IDK of any cases. But the PRESIDE trial showed that the triplet of docetaxel+enzalutamide+ADT was more effective than docetaxel+ADT in mCRPC even after enzalutamide failed previously.

prostatecancer.news/2022/10...

[Ian99 in reply to Tall_Allen]

Thanks for that. Encouraging results. Will discuss with oncologist.

[lcfcpolo]

I have to agree that this looks really promising. My guess is that Darolutamide may well in the future overtake Zytiga (Abiraterone) and Xtandi (Enzalutamide) as the most powerful hormone therapy.

Unfortunately we are dealing with the now. Like you, I have already started treatment. I'm thinking, is it worth asking your Oncologist if other treatments have failed, if Darolutamide can be prescribed. For sure it is currently for newly diagnosed patients but so what. Why not see if they can prescribe it compassionately. Some patients get Zytiga after Xtandi.

Thanks for posting this. This is an important development for treatment in the UK I think. Good luck.

[Blueribbon63]

As I understand, darolutamide has no effect on PSA but it is used to strengthen bones on advanced metastisized PC?

[Derf4223 in reply to Blueribbon63]

Do you really mean denosumab?

[Blueribbon63 in reply to Derf4223]

Yes, I am sorry, my bad

[Wife32]

If you’re not castrate resistant, this may be helpful info:

My husband’s doctor is using daralutamide along with adt and sometimes docetaxol in the United States. Below are 2 very recent publications relating to hormone sensitive use….may be good to discuss with your doctors if it is available. There are also a number of citations in the NEJ article for further information. The results appear to be positive, with little additional side effects over adt alone.

Erleada (apalutamide) is another drug that works well in hormone sensitive patients along with adt according to the latest studies.

Nubeqa for hormone sensitive cancer regardless of volume used in newly diagnosed or recurrent disease:

onclive.com/view/darolutami...

New England Journal of Medicine:

jamanetwork.com/journals/ja...

Our doctors here have been encouraged by the newer drugs and therapies, and are especially interested in the sequencing and combo use for different stages of disease. There is a lot going on in research!

Best of luck to you

[j-o-h-n]

Doc has me off casodex last month and I begin Nubequa (Darolutamide) in two days.....If it works my wife is giving me a party, if it doesn't she's giving me a funeral...............

Good Luck, Good Health and Good Humor.

j-o-h-n Monday 03/06/2023 7:29 PM EST

[Gl448 in reply to j-o-h-n]

John, you’re saying NUBEQA and no other treatments?

Is dropping the casodex an “ADT HOLIDAY” or a long term plan to stay off it in lieu of NUBEQA as a single drug therapy?

[j-o-h-n in reply to Gl448]

Sorry if I caused any questions....since I believe I will still be on the quarterly Lupron as well as the new addition of daily Darolutamide, NUBEQA.....

Now you know why I was married twice........

Good Luck, Good Health and Good Humor.

j-o-h-n Tuesday 03/07/2023 2:01 PM EST

[Gl448 in reply to j-o-h-n]

LOL about married twice.

Thanks John...it's so easy to misunderstand the wording of some posts.

Cheers!

[GeorgeGlass in reply to j-o-h-n]

Keep us posted on how it goes with the nubeqa, John. I just started on it ten days ago, and I am not feeling very good with the side effects. Maybe it is due to the 5mg of crestor, but I doubt it, because that is a low dose.

[j-o-h-n in reply to GeorgeGlass]

Of course I will..... just remember to ask me from time to time, my memory is gone except for humor. I'm taking (2 days so far) 300mg 2X in the AM and 2X in the PM (each time with food). Hopefully your side effects are just a temporary blip.

Regards as always.

Good Luck, Good Health and Good Humor.

j-o-h-n Friday 03/10/2023 11:52 PM EST

[j-o-h-n in reply to GeorgeGlass]

Of course I will...... but please remember to ask me from time to time....I'm forgetting everything except for humor.......Hopefully your reaction so far is just a minor blip...

Regards,

Good Luck, Good Health and Good Humor.

j-o-h-n Friday 03/10/2023 11:41 PM EST

[Teacherdude72]

Darolutamide, NUBEQA started as a medication to be used with ADT for non-mets pca with great success extending survival before mets. In the past year or two was approved for patients with mets with other treatments (not sure of these). I have been on Lupron and Nubeqa for 22 months with great success.

[j-o-h-n in reply to Teacherdude72]

Good Luck, Good Health and Good Humor.

j-o-h-n Friday 03/10/2023 11:58 PM EST

A happy apple for the Teacher.

A happy apple for the Teacher.

[GeorgeGlass in reply to Teacherdude72]

did you consider switching from lupron to orgovyx? Just curious.