Looking up the drug, Trodelvy, suggested in the slanted and disturbing email to Holly, one can get a picture of the landscape for metastatic triple-negative breast cancer. The drug was apparently approved based on data from 108 people in a phase I/II study. The efficacy seems marginal but would be priceless to the few that it helped survive. The side effects are discouraging. If this is the best available, trying a Leronlimab in a trial with its powerful MOA and good response in initial patients is a rational option, imo. I hope Leronlimab proves to be a godsend.
https://www.breastcancer.org/research-news/fd...tatic-tnbc
The FDA’s approval of Trodelvy is based on results from a phase I/II study published on Feb. 21, 2019, in The New England Journal of Medicine. The study included 108 people diagnosed with metastatic triple-negative breast cancer that had been treated with at least two previous therapies for metastatic disease. The people were followed for about 9.7 months.
The results showed that:
three of the cancers completely responded to Trodelvy, meaning the cancers became undetectable
33 of the cancers partially responded to Trodelvy, meaning the cancers stopped growing or shrank
This means the response rate was 33.3%. Overall, half of the cancers responded to Trodelvy for longer than 7.7 months and half responded for shorter periods of time.
“In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic triple-negative breast cancer and moves the needle towards better outcomes for patients with metastatic breast cancer,” said Aditya Bardia, M.D., director of precision medicine at the Center for Breast Cancer at Massachusetts General Hospital Cancer Center and lead author of the study.
The phase III ASCENT study looking at Trodelvy was recently stopped because the results were so encouraging. Continued approval of Trodelvy is likely to be based on results from the ASCENT study.
Trodelvy side effects
In the phase I/II study, 85% of the people treated with Trodelvy had a severe (grade three or four) side effect. About 32% of the people in the study had serious side effects. Three people stopped treatment because of side effects.
https://www.breastcancer.org/research-news/fd...tatic-tnbc
The FDA’s approval of Trodelvy is based on results from a phase I/II study published on Feb. 21, 2019, in The New England Journal of Medicine. The study included 108 people diagnosed with metastatic triple-negative breast cancer that had been treated with at least two previous therapies for metastatic disease. The people were followed for about 9.7 months.
The results showed that:
three of the cancers completely responded to Trodelvy, meaning the cancers became undetectable
33 of the cancers partially responded to Trodelvy, meaning the cancers stopped growing or shrank
This means the response rate was 33.3%. Overall, half of the cancers responded to Trodelvy for longer than 7.7 months and half responded for shorter periods of time.
“In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic triple-negative breast cancer and moves the needle towards better outcomes for patients with metastatic breast cancer,” said Aditya Bardia, M.D., director of precision medicine at the Center for Breast Cancer at Massachusetts General Hospital Cancer Center and lead author of the study.
The phase III ASCENT study looking at Trodelvy was recently stopped because the results were so encouraging. Continued approval of Trodelvy is likely to be based on results from the ASCENT study.
Trodelvy side effects
In the phase I/II study, 85% of the people treated with Trodelvy had a severe (grade three or four) side effect. About 32% of the people in the study had serious side effects. Three people stopped treatment because of side effects.
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