Remarkable Drug Trial Ends With All 18 Patients Cancer-Free: The results of the Phase II trial were published in the New England Journal of Medicine

Gizmodo via MSN ^ | 06/06/2022 | Ed Cara

[philippa]

Interesting, yes. Not conclusive. We’ve seen so many promising drugs over the years that haven’t planned out.

[philippa]

It’s a start, but too small to be conclusive. There needs to be a larger trial.

[LilFarmer]

I am leery of any drug ending in “mab” as many of them were developed using humanized mice (including this drug). List is here: https://en.wikipedia.org/wiki/List_of_therapeutic_monoclonal_antibodies

Some of these mice are humanized with fetal tissue/fetal stem cells and it is not always easy to find out which ones. Here are some:

https://www.fetalindustry.com/post/aborted-baby-organs-used-to-humanize-mice-for-covid-19-vaccine-and-therapeutic-testing

[LilFarmer]

Under “Ethical Statement”
Humanized NOG-EXL mice (highly immunodeficient NOG mice) expressing human GM-CSF and human IL-3, engrafted with CD34 human stem cells

http://www.anaptysbio.com/wp-content/uploads/Preclinical-characterization-of-dostarlimab.pdf

[JustOneStarfish]

By definition, a phase II trial is a small number of people.

Pre-clinical is animal studies/lab studies. Phase I is determining how large a dose is SAFE in humans (not effective, just SAFE). Phase II is determining if it is EFFECTIVE at levels below the phase 1 safety margins.

There doesn’t need to be “another trial.” This (or any other dug with similar profiles) just continues on through the next phase of testing. If it is shown to be effective in Phase II trials, it moves to Phase III. Phase III is expanding to a much larger group. They don’t just look at a few monkeys or petri dishes and then release this or any other drug on a huge number of people.

There is value and relevance in results of EVERY phase of testing, including failure levels. This drug shows a lot of promise on a small, well-controlled group of people.