Starting Orgovyx and Nubeqa. Your experience?

[KMY28]

Curious to know your side effects, what you did to deal with them, anything expected or unexpected, plusses and minuses? Thanks in advance.

[vintage42]

Did you do anything special to get the combination of Orgovyx and Nubeqa? Last winter I was not allowed to add Nubeqa to my Orgovyx unless I also took docetaxel, which I did not want. Your bio does not seem to meet the requirements for Nubeqa because you are metastatic and not taking docetaxel in triplet.

According to my MO and Nubeqa's website Nubeqa has presently only been authorized for (1) non-metastatic, castration resistant PCa and (2) for newly diagnosed with metastases in combination with docetaxel (triplet). Apparently that came out of the ARASENS trial.

However, my MO said that Nubeqa is expected to be allowed in doublet without docetaxel after the new ARANOTE trial ending this month, and I see that has now happened:

"In the Phase III ARANOTE trial... NUBEQA plus ADT now has demonstrated efficacy data in metastatic hormone-sensitive prostate cancer (mHSPC) both with and without docetaxel..." bayer.com/en/us/news-storie...

[KMY28 in reply to vintage42]

Hmm. I'll be very honest and say I did nothing other than have the consultation and go over all of my scans and results. Is this combo something you want for a particular reason, and is docetaxel something you don't want? I'd appreciate your thoughts on each as all three names are entirely new to me. I am, however, newly diagnosed with metastases but there was no mention of docetaxel yet. My plan, as far as I understand, is Orgovyx and Nubeqa for several weeks (6?) then a combination of brachy radiaion and beam radiation, followed by 3 to 4 sessions of chemo. Is that the docetaxel you're talking about? (BTW I'm sure people are reading this and rolling their eyes at my daftness, but I'm seriously only four weeks into my diagnosis and all of this is completely unfamiliar to me! I appreciate your patience)

[dhccpa in reply to KMY28]

Docetaxel is chemotherapy, not radiation.

[vintage42 in reply to KMY28]

So systemic treatment starts with hormone therapy (androgen deprivation therapy or ADT) of which the pill Orgovyx (relugolyx) is one example. It is often supplemented with so called second generation drugs called androgen receptor inhibitors (AR) of which Nubeqa is one example. This is called doublet therapy. For even better effect, a chemotherapy pill can be added, such as Taxotere (docetaxel), called triplet therapy.

I started Orgovyx and wanted to add Nubeqa because it did not cross the blood-brain barrier like the two other competing ARs, Erleada and Xtandi. But at 81, I did not want to add chemo which adds more side effects. I was denied Nubeqa in doublet, so I chose Zytiga (abiraterone), which must be taken with the steroid Prednisone.

If given the opportunity to change from Zytiga to Nubeqa in doublet therapy, I would take it. It looks like the ARANOTE trial will lead to approval of Nubeqa in doublet.

[vintage42 in reply to vintage42]

'"... chemotherapy pill can be added..."

Correction, the chemo drugs are IV infusions, not pills.

[KMY28 in reply to vintage42]

Got it. I now understand that Taxotere (docetaxel) is the chemo.

[dhccpa in reply to vintage42]

So Nubeqa IS now approved for metastatic patients? Did I read that correctly? Thanks

[vintage42 in reply to dhccpa]

No, a trial is not approval.

The ARAMIS trial showed the safety and efficacy of the triplet of Nubeqa + ADT + Chemo. So Nubeqa was approved by the FDA in that combination.

The ARANOTE trial has now shown the safety and efficacy of the doublet of Nubeqa + ADT. So I expect the FDA will soon approve that combination.

[dhccpa in reply to vintage42]

Got it thanks

[j-o-h-n]

Been on Nubeqa since April of 2023, so far NO side effects...... (I'm on Lupron also). Keep your chin up......

Good Luck, Good Health and Good Humor.

j-o-h-n

[85745]

I am on Orgovyx and Nubeqa for 8months now, No side effects other than very mild hot flashes now and then. No chemo or Radiation and was approved ( grant ). my psa has dropped from 45 to 0.5 had one test before the 45 that was 254. but next test showed the 45 before the 254 it was25.4 you can see the mistake in the decimal pt location.... maybe. So yes on the Orgo and Nubeqa so far.

[KMY28 in reply to 85745]

Thanks. Good to know 8 months with only mild side effects.

[ARIES29]

I am on Nubeqa 120mg day & Docetaxel injection every 3 months. The side effects so far for me are sleepless nights, constipation & these damn hot flushes all night. Reducing the Nubeqa to 900mg day helps & melatonin before bed allows me sleep in 2 hour shifts.

The joys of life! I live for my 11 y old daughter but as soon as the pain sets in ADIOS!