Clinical trial tyros--what do you think?

[dentaltwin]

Sometimes, I think data from a clinical trial can be massaged and polished into a bright shiny object that tells you little. This article, about use of ipilumimab (Yervoy--Bristol Myers Squibb) in mCRPC) seems like one of those instances. What do you think?

medpagetoday.com/hematology...

[Tall_Allen]

I wrote about the same trial (below) but had a different understanding about it. Media often try to spin research results to get a more sensational story.

prostatecancer.news/2016/08...

[dentaltwin in reply to Tall_Allen]

Sometimes it seems to me that BMY is trying desperately to make the case for Yervoy. The article is behind a paywall; evaluating a "piecewise hazard model" in any case is above my pay grade.

europeanurology.com/article...

[Tall_Allen in reply to dentaltwin]

I read the full text for my article - nothing worth mentioning beyond what I mentioned. The piecewise hazard model just said that the effect changed from negative to positive after 5 months of f/u.

[dentaltwin in reply to Tall_Allen]

Thanks!

[p3d1]

“Several molecular markers, such as tumor mutational burden and mismatch repair deficiency, have shown little correlation with response to immunotherapy.“

This is just wrong.

TMB has been FDA approved for Keytruda across multiple cancers regardless of location ( June 16th 2020).

The latest research would indicate that several biomarkers , MSI-H, dMMR, PL-L1, TMB hypermutated ( >10), TMB ultramutated (>100 )when combined with MSI-L ( POLE and POLD1), CHEK-1 and possibly HRR ( BRCA 1/2 etc) can strongly suggest immunotherapy.

If someone has a couple of these then that person should get access.

It is irresponsible that the trial should make a statement like that.

[dentaltwin in reply to p3d1]

In fairness, this article does not mention pembrolizumab (Keytruda); nevertheless, sweeping statements like the one you cite are not helpful--I agree.

[p3d1 in reply to dentaltwin]

It did not mention it by name but it dismissed all checkpoint inhibitors with an incorrect statement. It would make you doubt the people writing the report if they are so out of date with immunotherapy treatments. I do not think it was malicious but does appear careless. Thank you for bringing it to our attention.

[tango65]

This is a link to the full article:

sci-hub.st/https://doi.org/...

It seems a good study.

The authors never mentioned:

“Several molecular markers, such as tumor mutational burden and mismatch repair deficiency, have shown little correlation with response to immunotherapy".

The author of the article, Charles Bankhead (senior editor) did.

[dentaltwin in reply to tango65]

I re-read it; it is not clear if Bankhead is stating this himself, or whether the source of this nugget is Lawrence Fong (or somewhere else); in any case he shouldn't have thrown this statement out without clear attribution.

[p3d1]

Tango 65

That better explains the statement. It was difficult to accept that scientists would make such a comment.

It goes to the heart of Dentaltwin’s premise that some articles are massaged to increase the impact.

That is serious when it comes to peoples health.

[dentaltwin in reply to p3d1]

tango65 states that that comment is nowhere found in the source paper, so it may be Bankhead, or another source. Bankhead makes no disclosures of interest, but the study was clearly supported by Bristol Myers Squibb.

[j-o-h-n in reply to p3d1]

To p3d1,

Holy Chit..... don't tell that published data is massaged for publication. Next you'll tell me the tooth fairy wears dentures.....

Good Luck, Good Health and Good Humor.

j-o-h-n Sunday 10/04/2020 6:33 PM DST

[p3d1 in reply to j-o-h-n]

j-o-h-n,

Everyone knows they wear dentures.....

All the best

[dentaltwin in reply to p3d1]

Shhhhhh!!!

[j-o-h-n in reply to p3d1]

LOL .......Oh chit again..... they didn't c.c. me on the memo.....

Good Luck, Good Health and Good Humor.

j-o-h-n Monday 10/05/2020 5:52 PM DST