RE:RE:Over $400k annually for… Another variable to consider is the treatment landscape for metastatic cervical cancer. The limited drugs approved may have lowered the bar on this one. It definitely looks like a mixed bag of results. It would be interesting to see the very earliest data releases on this program to see whether you could discern an approvable dataset at that time.
Another interesting number coming out of this trial is
"The median time to response was 1.4 months (range, 1.1-5.1), with activity generally observed within the first two treatment cycles."
Not so much for approval but for our wait for efficacy data now. This ADC shows a very fast measurable response at the start of treatment hopefully th1902 obliges in this way and helps with the wait time for an efficacy announcement.
Wino115 wrote:
Another ADC is good news, especially as the BLA was filed in Feb, Accellerated App granted in April, and now approved in Sep. All on phase 2 with 101 patients and an objective response of only 24% and durability of response of 8 months in cervical cancer, but with a high percentage of safety issues many of which are on the serious side (50% for hemoglobin and lymphocyte decrease and 40% peripheral neuropathy) .
So the ADC not internalizing a lot of the chemo clearly leads to issues with dosage, duration and treatment window. More numbers and a timeline to keep in mind. On that timeline, you could see TH1902 move pretty fast based on positive results.