ASCENT phase III trial ended early
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Topic: ASCENT phase III trial ended early
Posted By: strongtogether
Subject: ASCENT phase III trial ended early
Date Posted: Apr 10 2020 at 7:06am
https://www.biospace.com/article/immunomedics-breast-cancer-trial-early-because-it-works-so-well/%20" rel="nofollow - https://www.biospace.com/article/immunomedics-breast-cancer-trial-early-because-it-works-so-well/
So I understand that this was a trial on metastatic tnbc patients. What exactly does this result mean? Does the medicine (sacituzumab govitecan) get patients to remission?
What are the implications for patients who have local tnbc?
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Replies:
Posted By: 123Donna
Date Posted: Apr 13 2020 at 8:21am
The ASCENT trial acts as a confirmatory dataset to the results seen in the phase I/II trial, which were published in the New England Journal of Medicine.2
In the heavily pretreated population, sacituzumab govitecan achieved durable objective responses.
Out of 108 patients, the response rate was 33.3%, which included
complete responses in 2.8% of patients, per local assessment. Partial
responses were achieved in 30.6% of patients, per investigator
assessment. Additionally, there was a 37.0% rate of stable disease and
25.9% of patients had progressive disease. The clinical benefit rate
observed was 45.4%, which included stable disease for at least 6 months.
Among the 39 patients who responded to treatment, the median time to
response was 2.0 months (range, 1.6-13.5) and there was a 7.7-month
median duration of response ([DOR]; 95% CI, 4.9-10.8). Data were also
assessed by blinded independent review, which showed a similar response
rate of 34.3% (95% CI, 25.4%-44.0%) and median DOR of 9.1 months (95%
CI, 4.6-11.3). According to local assessment, sacituzumab govitecan had a
59.7% estimated probability of eliciting response at 6 months. The
estimated probability that patients would respond to treatment at 12
months was 27.0%.
By the data cutoff date, long-term responses over 12 months (range, 12.7-30.4) were seen in 6 patients.
https://www.targetedonc.com/news/compelling-sacituzumab-govitecan-data-in-mtnbc-add-to-fda-approval-hopes" rel="nofollow - https://www.targetedonc.com/news/compelling-sacituzumab-govitecan-data-in-mtnbc-add-to-fda-approval-hopes
------------- DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09) 11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
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Posted By: strongtogether
Date Posted: Apr 14 2020 at 7:49am
What does that all mean in effect, Donna? Is this a drug used for metastatic cancer only, or is there any application for it to be used for local cancer in some way?
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Posted By: 123Donna
Date Posted: Apr 14 2020 at 11:55am
This is just my two cents. With the study being halted early due to
promising results may mean that it could get FDA approval sooner, than
later, as a treatment choice for metastatic TNBC.
It may not make it to
the standard of care for non-metastatic patients. There could be a study looking at using this drug in the neoadjuvant setting to see if it helps achieve pCR better than standard chemo. This drug is not without side effects: "In terms of safety, the most common any-grade adverse events (AEs) were
nausea (67%), neutropenia (64%), diarrhea (62%), fatigue (55%), and
anemia (50%)."
------------- DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09) 11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15
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