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ASCENT phase III trial ended early

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URL: http://forum.tnbcfoundation.org/forum_posts.asp?TID=13681
Printed Date: Mar 28 2024 at 4:07am
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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?




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





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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



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?



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%)."


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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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