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.
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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.