RE:RE:RE:RE:RE:10 questions from RBC January 8This is common for all cancer trials.
When used as a clinical endpoint for clinical trials of cancer treatments, this often called the objective response rate (ORR). The FDA definition of ORR is "the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period."
Duration of response, or DoR, is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. Cancer drugs that demonstrate improved DoR can produce a durable, meaningful delay in disease progression, as opposed to a temporary response without any lasting
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the OS is one way to see how well a new treatment works. Also called overall survival.
SPCEO1 wrote: Since amny of us are not familiar with oncology, could yo give us a brief explanation of ORR, DOR and OS. Also, what is the toxicities issue?
I am also not sure what you meant when you were referring to the biopsy in NASH as a weakness. All NASH trials involve biopsies, so it is a weakness shared by all NASH companies.
qwerty22 wrote: I see cancer as data driven, it's hard to ignore ORR or DOR, they should speak loadly, I guess you could ignore them if you want to focus on corporate competence.
Here's a meta-analysis of mTNBC lots of numbers to pick out of that but my summary of the present tested drugs.
https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-019-1210-4#Tab1
10-20% ORR
4-6months DOR
12-18months OS
50-66% grade 3+ toxicities
This is what the drug needs to beat to look promising. Sutro is doing that but in Ovarian and the SP over the past 12-18 months looks great even with a drug related death.
I actually also see NASH as data driven and in that case very focused on the biopsy endpoints as the foundation for a program. I still think collectively we are under-estimating the importance of that weakness at least to the perception of the program.
scarlet1967 wrote: Most of questions are relevant but it seems there are so much pending doubts regarding company's ability to execute so even when they produce good results it won't be factored in by the market, I believe the problem is the failed IR and inability to convince the investors of course the recent deal wasn't helpful at all.
But if company can address these questions in a convincing manner going forward it will definitely help the valuation imo, therefore they need to have a serious discussions re changing their failed strategy.