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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Triple Negative Breast Cancer |
| Drug: | Trodelvy (sacituzumab govitecan-hziy) (Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Title:
Everest Medicines Announces Approval of Trodelvy® in China for Second-Line Metastatic Triple-Negative Breast Cancer
Published date:
06/10/2022
Excerpt:
Everest Medicines...announced today that China’s National Medical Products Administration (NMPA) has approved Trodelvy®(sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Source:
Title:
Trodelvy® (sacituzumab govitecan) Granted European Commission Marketing Authorization for Treatment of Metastatic Triple-Negative Breast Cancer in Second Line
Published date:
11/23/2021
Excerpt:
Gilead Sciences, Inc...today announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan), a first-in-class Trop-2-directed antibody-drug conjugate, as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease
Source:
Title:
Gilead Marks Fifth Approval for Trodelvy® in Metastatic Triple-Negative Breast Cancer Under Project Orbis Initiative with Health Canada Authorization
Published date:
09/27/2021
Excerpt:
Gilead Sciences, Inc....announced that Health Canada has approved Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior therapies, at least one of them for metastatic disease
Source:
Published date:
04/07/2021
Excerpt:
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Source:
Title:
NICE recommends Piqray and Trodelvy, maintaining 100% approvals of breast cancer drugs since 2018
Published date:
07/14/2022
Excerpt:
NICE has also recommended Trodelvy (also called sacituzumab govitecan and made by Gilead Sciences) for treating locally advanced or metastatic triple negative breast cancer which can’t be removed surgically.
Source:
Published date:
12/10/2021
Excerpt:
Recommendation 1.3….Patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease should be offered treatment with sacituzumab govitecan…
DOI:
10.1200/JCO.21.01374
Source:
Excerpt:
HER-2 negative...Other recommended regimens...sacituzumab govitecan-hziy (for TNBC)...
Source:
Title:
Sacituzumab govitecan as second-line treatment for metastatic triple-negative breast cancer-phase 3 ASCENT study subanalysis
Published date:
06/09/2022
Excerpt:
SG prolonged progression-free survival (median 5.7 vs 1.5 months [HR, 0.41; 95% CI, 0.22-0.76]) and overall survival (median 10.9 vs 4.9 months [HR, 0.51; 95% CI, 0.28-0.91]) vs TPC... In this second-line setting, as with later-line therapy, SG improved survival over conventional chemotherapy for patients with mTNBC.
DOI:
10.1038/s41523-022-00439-5
Source:
Title:
Sacituzumab Govitecan Receives Positive CHMP Opinion as 2L Treatment for Adult Patients With Metastatic Triple-Negative Breast Cancer
Published date:
10/15/2021
Excerpt:
Gilead Sciences..the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for sacituzumab govitecan as monotherapy indicated for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC)...The positive opinion is supported by results from the Phase 3 ASCENT study, where sacituzumab govitecan showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death and improved median progression-free survival (PFS)...
Trial ID:
Source:
Title:
Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
Published date:
04/22/2021
Excerpt:
In this randomized, phase 3 trial, we evaluated sacituzumab govitecan...in patients with relapsed or refractory metastatic triple-negative breast cancer….The median progression-free survival was 5.6 months (95% confidence interval [CI], 4.3 to 6.3; 166 events) with sacituzumab govitecan...The median overall survival was 12.1 months (95% CI, 10.7 to 14.0) with sacituzumab govitecan...Progression-free and overall survival were significantly longer with sacituzumab govitecan...
DOI:
10.1056/NEJMoa2028485
Trial ID:
Source:
Title:
Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer
Published date:
11/17/2020
Excerpt:
...median PFS was 2.8 mo (95% CI, 1.5-3.9) for SG vs 1.6 mo (95% CI, 1.3-2.9) for TPC by central review,...Stable disease was achieved in 15 (47%) pts with SG vs 9 (31%) pts with TPC.
Trial ID:
Source:
Title:
LBA17 - ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC)
Published date:
09/14/2020
Excerpt:
In the ASCENT study (NCT02574455), pts with mTNBC... were randomized 1:1 to receive SG (10 mg/kg IV on d 1, 8 every 21 d) or single-agent TPC (capecitabine, eribulin, vinorelbine, or gemcitabine)...SG (n=235) compared with TPC (n=233) significantly improved mPFS (5.6 vs 1.7 mo; HR, 0.41; P<0.0001) and median OS (12.1 vs 6.7 mo; HR, 0.48; P<0.0001). ORR was 35% for SG vs 5% for TPC (P<0.0001). ASCENT is the first phase III study of an ADC with significant PFS and OS improvement over SOC chemotherapy in pretreated mTNBC, confirming the clinical activity and safety profile of SG monotherapy.
Trial ID:
