OnCo
trialsTrialPositive

ASCENT

The trial that proved a TROP2 ADC could nearly double survival in heavily pretreated triple-negative breast cancer.

529 patients, ≥2 prior lines. PFS 5.6 vs 1.7 months; OS 12.1 vs 6.7 months (HR 0.48). Benefit regardless of TROP2 expression level, a finding that shaped the field's view that IHC selection is unnecessary for TROP2 ADCs.

Setting
Pretreated metastatic TNBC: sacituzumab govitecan vs chemotherapy
Phase
Phase 3
Sponsor
Gilead (Immunomedics)
Registry
Headline result
OS 12.1 vs 6.7 months, HR 0.48.
Reported
2020
Enrolled
529
Replication
Consistent with the single-arm IMMU-132-01 basket (ORR 33%) that led to accelerated approval, with TROPiCS-02 in HR+ disease, and with the first-line ASCENT-03/04 results; real-world series report similar PFS.

Outcomes

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In plain words
What these results mean for people, not percentages
529 people took part
Progression-free survival (patients without brain metastases)primarysurrogate endpoint
  • Median 5.6 vs 1.7 months with Sacituzumab govitecan compared with Chemotherapy (TPC); about 3.9 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 59 percent lower chance of the event at any given time (hazard ratio 0.41, likely range 0.32 to 0.52).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
  • Median 12.1 vs 6.7 months with Sacituzumab govitecan compared with Chemotherapy (TPC); about 5.4 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 52 percent lower chance of the event at any given time (hazard ratio 0.48, likely range 0.38 to 0.59).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Objective response rateresponse endpoint
  • 35 vs 5 out of 100 had their tumour shrink with Sacituzumab govitecan compared with Chemotherapy (TPC); 30 more per 100.
  • Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Be careful
  • These results apply to the people the trial enrolled: Pretreated metastatic TNBC: sacituzumab govitecan vs chemotherapy. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

529 participants enrolled.

Progression-free survival (patients without brain metastases)primary
HR 0.41 (0.32–0.52) · p <0.001
Sacituzumab govitecan
5.6 mo
Chemotherapy (TPC)
1.7 mo
Source
Overall survival
HR 0.48 (0.38–0.59) · p <0.001
Sacituzumab govitecan
12.1 mo
Chemotherapy (TPC)
6.7 mo
Source
Objective response rate
Sacituzumab govitecan35 of 100
Chemotherapy (TPC)5 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (patients without brain metastases)primarySacituzumab govitecan2355.6 months0.41 (0.32–0.52)<0.001link
Chemotherapy (TPC)2331.7 months
Overall survivalSacituzumab govitecan12.1 months0.48 (0.38–0.59)<0.001link
Chemotherapy (TPC)6.7 months
Objective response rateSacituzumab govitecan35%link
Chemotherapy (TPC)5%
Replication
Consistent with the single-arm IMMU-132-01 basket (ORR 33%) that led to accelerated approval, with TROPiCS-02 in HR+ disease, and with the first-line ASCENT-03/04 results; real-world series report similar PFS.

Key papers

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Connected

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Pages like this

not linked directly; found by shared links