Another promising androgen blocker in clinical trials: Darolutamide (ODM-201)

Another second line androgen blocker, Darolutamide is in phase III clinical trials. It's showing quite a bit of promise so far. It may prove to be more effective than other AR blockers currently being used and tested.

This is certainly one worth keeping an eye on.

Here's a quote from an article:

"One advantage is that darolutamide has been found to block the activity of all tested/well-known mutant ARs in prostate cancer, including the recently identified clinically-relevant F876L mutation that produces resistance to enzalutamide and apalutamide.

Here's a link:

ncbi.nlm.nih.gov/pubmed/284...

[Dan59]

Good to know they are working on new and better androgen blockers. I checked the trials 339 locations, unfortunately I would be excluded from this trial, Lets hope it gets fast tracked.

Exclusion Criteria:

•Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201; other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization.

clinicaltrials.gov/ct2/show...

[Hidden in reply to Dan59]

Wow, that's a pretty exhaustive list of exclusions. I wonder if they are expecting to use this as Primary ADT.

[Dan59 in reply to Hidden]

It seems I must have it wrong as why would they exclude all these therapies, when this is supposed to work when the others have failed.

[Hidden in reply to Dan59]

You correctly quoted the exclusion criteria for the ARASENS trial. I think there is another trial going on as well.

It looks like they want to start with patients that have had no treatment for PCa, then use the current Standard of Care plus Darolutamide.

[pjoshea13 in reply to Dan59]

The strategy often used with a new drug is to test on CRPC cases, because (a) accrual is not a problem, (b) there are fewer ethical considerations & (c) the FDA will fast track anything with even modest benefit in CRPC cases.

But that's a foot in the market ploy. The ultimate target is new ADT cases.

A bit aggressive though, for a trial to combine with Taxotere in new ADT cases, IMO.

Calls itself a "Phase III Study", but "The purpose of the study is to assess the efficacy and safety" of the combo. "Safety"? Isn't that Phase I?

I wonder what accrual is like?

-Patrick

[Hidden in reply to pjoshea13]

Agree, looks like they are going for the "early use" concept, similar to STAMPEDE and LATITUDE and hoping to achieve a similar result. I also think it's a bit ambitious. Wish they had started with CRPC patients.

[Hidden in reply to pjoshea13]

It's a new trial, they just started enrolling patients in Nov, 2016. They are expecting 1300 patients and the trial is expected to be completed in 2022. Hoping to be around then, but who knows.

[wifeofvet in reply to Hidden]

2022 ???

can't wait that long. already flunked everything else. PSA RISING LIKE LIGHTNING.

[wifeofvet in reply to wifeofvet]

it's gotta be approved before that. they've already entered into production and marketing partnerships.

[Bobkar in reply to wifeofvet]

I’m wondering if the patients on the trial will automatically get the drug when trial is over, even the ones that were on the placebo.

[Grandpa4 in reply to pjoshea13]

safety is the priority in phase 1 trials but assessing safety is always an objective of every trial.

[Hidden]

There's another trial called ARAMIS. The first exclusion on the list is: "History of metastatic disease at any time or presence of detectable metastases."

Guess most of us here can forget about that one.

[wifeofvet]

onclive.com/publications/on...

[rococo]

Another new and improved antiandrogen coming down the pike. These drugs are more specific blocking testosterone from the pc rather than the whole body. Wonder if combining the old ones flutamide etc.with the new sequencing and rechallenging for chronic controll .

[Dan59]

Gregg, thanks for posting, This sounds real good. I am looking for hope tonight.

Dan

[wifeofvet]

apalutamide was approved by the fda on feb 16th....yet another one.

[Hidden in reply to wifeofvet]

It looks like it's an improvement over Xtandi (enzalutamide) when it comes to crossing the blood-brain barrier. I think it's about 1/4 of enzalutamide so the risk of seizures is less. As far as I know, it has not been approved for metastatic castrate resistant prostate cancer.

[wifeofvet in reply to Hidden]

my husband passed away just 2 weeks before apalutamide was approved. his oncologists had no problem with him being put on apalutamide despite extensive bone mets. organ mets, no...but, bone mets, yes. unfortunately, he died two weeks too soon.

[jkholmes in reply to wifeofvet]

Sorry for your loss. God Bless

[wifeofvet in reply to jkholmes]

thank you

[Dan59 in reply to wifeofvet]

May God Bless You wife of vet, and may he rest in Peace. I am glad you are still in the forum.

[Hidden in reply to wifeofvet]

Very sorry to hear. I know you were trying to get Darolutmide a while back. They need to move faster with these drugs, the whole approval process seems so slow.

[wifeofvet in reply to Hidden]

actually, i tried to get darolutamide under the ''right to try'' rules before it was approved and two researchers independently replied that it was NOT for cases as advanced as his. they said, essentially, that it was only for early stage cancer.