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ASCENT phase III trial ended early

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strongtogether View Drop Down
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    Posted: Apr 10 2020 at 7:06am
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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post 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.




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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Post Options Post Options   Thanks (0) Thanks(0)   Quote strongtogether Quote  Post ReplyReply Direct Link To This Post 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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post 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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