ARSI PR wars: Nubeqa (Bayer) vs Erleada (J & J) lawsuit

@jeffmarc yes..brainfog..I dont think I am any more foggy than before I started ADT...again, thank you for all your insights on PC and treatment..I mean this site and real life accounts of PC struggles and triumphs is invaluable...I am very fortunate to have stumbled on it in my early PC days of panic and fear.

As for Erleada vs Nubeqa..I think Johnson and Johnson has lost thousands of Erleada customers ( and Million$$$) and decided to fight back with a story of statisical data favoring Erleada. Again, for me, I couldnt tolerate the drug...Nubeqa seems to be working well for me and even works alone and covers castrate resistance PC metastis as well... ( I thinK?)

Hopefully in not too distant future, the drugs which can make our immune systems quickly target and eradicate cancer will be available in time for some of us old guys to not have to wake up each day to workout, jog and take PC medication with religious fervor

Yes, it's entirely possible that new RWAs will emerge to support Nubeqa's original claims (and some of the anecdotal evidence here in the forum).

But also, even if the next study flips the numbers and concludes that it's actually Darolutamide (Nubeqa) that causes fatigue in "only" 7.5% of patients while Apalutamide (Erleada) causes it in 7.9% of patients, how big a practical difference would that make? The biggest finding I took from that study wasn't that Apalutamide outperformed Darolutamide, but that there really wasn't much difference among the three -lutamides. The "blood-brain barrier" stuff was no doubt true during in-vitro lab testing — and it makes great marketing copy — but we're still waiting for real-world head-to-head scientific evidence supporting that hypothesis.

It may be that the placebo effect is in play here, too. Since oncologists sincerely believed that Nubeqa would have fewer congitive side-effects, they'd pass that belief onto their patients, and that alone might make some of them feel better as soon as they switch. 🤷

p.s. No implied criticism for switching. Obviously, if you start on any drug and you're not tolerating it well, it makes sense to switch to another if one's available.

@xahnegrey40 J&J consistently, and for decades, has manipulated and ‘massaged’ data from their own studies.
It wouldn’t surprise me if entire sections of data were added/omitted or simply rewritten.
Execs have perjured themselves on the witness stand and then gone on to win US presidential awards for merit.
Remember, “The business of America - is business”!
Phil

It would seem to me that going back to the clinical trials data would be more productive than consideration of the litigation details,

There’s so much clinical data out there available for us to review ourselves. Here’s juts a few:

@brianjarvis
Interesting how the last chart shows Darolutamide Is more effective than the other three drugs as far as overall survival is concerned for Castrate sensitive people.

@jeffmarc Though I would go by the clinical trial outcomes (rather than the legal arguments in court litigation), I also understand the difficulty in extrapolating those population outcomes to a specific patient’s outcome.

@brianjarvis AFAIK, there hasn't been a lot of head-to-head overall-survival comparison of the ARSIs (pulling numbers from different studies with different methodologies into the same table or website can be highly misleading), and there haven't been many real-world assessments comparing side-effects, either.

That's what's so interesting about the big retrospective study I shared earlier: it was limited to nmCRPC (probably because -lutamides other than Apalutamide hadn't been approved long enough for mCSPC to provide good samples), and while it found that Apalutamide produced the fewest de-novo central-nervous-system side-effects and Enzalutamide produced the most (with Darolutamide in the middle), they were all so close that it likely doesn't matter to patients, just to the marketing departments at Johnson & Johnson, Pfizer, and Bayer.

tl;dr All the -lutamides are good. Bayer's marketing may be feeding us 🐂💩 about Nubeqa's central-nervous system advantages over the others, while Johnson & Johnson's may be feeding us the same about Erleada's overall survival advantages. I suspect the only reason Pfizer's isn't joining in with Xtandi is that their U.S. Enzalutamide composition patent expires in 2027 anyway. 🤷

@northoftheborder My thinking is that if funding existed for a head-to-head comparison, that it might get done. Short of that, “pulling numbers from different studies…..” is all that we’ll have available.

As each 2nd generation androgen receptor pathway inhibitor therapy was developed, and side-effects, efficacy, etc, became more understood, the next ARPI was developed to reduce and (hopefully) resolve those known side/effects, then went through clinical trials, and eventually were FDA-approved over a number of years:
> Zytiga (abiraterone): 11/2012
> Xtandi (enzalutimide): 6/2013
> Erleada (apalutimide): 2/2018
> Nubeqa (darolutamide): 8/2022

Unfortunately, each new ARPI introduced its own side-effects, that now the choice of ARPIs - no different from the choice of surgery vs radiation for primary treatment - might primarily come down to which side/after-effect one wants to avoid.

Well, we did have the retrospective head-to-head RWA on side-effects that I linked to earlier in the thread, but yes, a full-scale, head-to-head phase 4 trial would cost a lot of money.

I expect we'll see Enzalutamide replace Abieraterone as the insurers' default/inexpensive option as soon as there are generics available, and Abiraterone will start to fall off oncologists' radars.

There's really little/no downside in moving from Abieraterone to a -lutamide, and the huge upside of no longer forcing patients to take a steroid (with its own, extr collection of nasty side-effects).

Im on nubeqa and thank the Lord i have lots of energy; I walk beyween.3 -7 miles generally about 2-3 x per week