I checked out the Tecentriq trial in which ( I guess ) leron would have been given concurrently to patients who applied to the leron trial.
From the Esmo poster
"7 patients were treated with leronlimab *in combination* with atezolizumab/Tencentriq, Pembro, nivolumab."
n=4= atezolizumab/Tencentriq
So Im assuming, but may be wrong, that all the patients given tecentriq were due to a situation similar to the lady in the article. They were admitted to the tecentriq trial, then applied to get in the Leron compassionate use trial.
I think what im wondering is how much the 4 patients given leron positively enhanced the overall trial results?
Maybe not much and maybe it doesnt matter. but tencentriq received accelerated approval which was then withdrawn from tnbc.
Could Leron have been completely/partially responsible for the accelerated approval?
Here are a couple response rates/stats from the tencentriq trial if someone can better break them down than me. If anyone cares.
https://clinicaltrials.gov/study/NCT03371017?tab=results
**Note- Where is that 68 months figure coming from. Sounds familiar.
Original number patients in Tencentriq + Chemo subset. n=297
"DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions
-Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
n=61
6.60 (4.63 to 8.02)
-18-month survival rate was defined as the percentage of participants alive 18 months after randomization.
n=188
27.05(20.39 to 33.71)
-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed objective response (OR). OR was defined as either a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions
n=154
39.6 (31.83 to 47.80)
-C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions
n=40
7.43(5.55 to 12.98)
From the Esmo poster
"7 patients were treated with leronlimab *in combination* with atezolizumab/Tencentriq, Pembro, nivolumab."
n=4= atezolizumab/Tencentriq
So Im assuming, but may be wrong, that all the patients given tecentriq were due to a situation similar to the lady in the article. They were admitted to the tecentriq trial, then applied to get in the Leron compassionate use trial.
I think what im wondering is how much the 4 patients given leron positively enhanced the overall trial results?
Maybe not much and maybe it doesnt matter. but tencentriq received accelerated approval which was then withdrawn from tnbc.
Could Leron have been completely/partially responsible for the accelerated approval?
Here are a couple response rates/stats from the tencentriq trial if someone can better break them down than me. If anyone cares.
https://clinicaltrials.gov/study/NCT03371017?tab=results
**Note- Where is that 68 months figure coming from. Sounds familiar.
Original number patients in Tencentriq + Chemo subset. n=297
"DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions
-Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
n=61
6.60 (4.63 to 8.02)
-18-month survival rate was defined as the percentage of participants alive 18 months after randomization.
n=188
27.05(20.39 to 33.71)
-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed objective response (OR). OR was defined as either a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions
n=154
39.6 (31.83 to 47.80)
-C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions
n=40
7.43(5.55 to 12.98)
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