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Trodelvy approved by FDA for unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer


The Food and Drug Administration ( FDA ) has approved Trodelvy ( Sacituzumab govitecan-hziy; Sacituzumab govitecan ) for patients with unresectable locally advanced or metastatic hormone receptor ( HR )-positive, human epidermal growth factor receptor 2 ( HER2 )-negative ( IHC 0, IHC 1+ or IHC 2+/ISH- ) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Efficacy was evaluated in TROPiCS-02, a multicenter, open label, randomized study in 543 patients with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer whose disease progressed after the following in any setting: a CDK 4/6 inhibitor, endocrine therapy, and a taxane.
Patients received at least two prior chemotherapies in the metastatic setting ( one of which could be in the neoadjuvant or adjuvant setting if recurrence occurred within 12 months ).

Patients were randomized ( 1:1 ) to Sacituzumab govitecan, 10 mg/kg as an intravenous infusion, on Days 1 and 8 of a 21-day cycle ( n=272 ) or single agent chemotherapy ( n=271 ).
Single agent chemotherapy was determined by the investigator before randomization from one of the following choices: Eribulin ( n=130 ), Vinorelbine ( n=63 ), Gemcitabine ( n=56 ), or Capecitabine ( n=22 ).
Randomization was stratified by the following factors: prior chemotherapy regimens for metastatic disease ( 2 vs. 3-4 ), visceral metastasis ( Yes or No ), and endocrine therapy in the metastatic setting for at least 6 months ( Yes or No ).
Patients were treated until disease progression or unacceptable toxicity.

The primary efficacy outcome measure was progression-free survival ( PFS ) determined by blinded independent central review per RECIST v1.1.
A key secondary efficacy outcome measure was overall survival ( OS ).
Median PFS was 5.5 months ( 95% CI: 4.2, 7.0 ) in the Sacituzumab govitecan arm and 4 months ( 95% CI: 3.1, 4.4 ) in the single agent chemotherapy arm ( hazard ratio [ HR ] of 0.661 [ 95% CI: 0.529, 0.826 ]; p-value=0.0003 ).
Median overall survival was 14.4 months for those receiving Sacituzumab govitecan ( 95% CI: 13.0, 15.7 ) and 11.2 months ( 95% CI: 10.1, 12.7 ) for those receiving single agent chemotherapy ( HR of 0.789 [ 95% CI: 0.646, 0.964] ; p-value=0.0200 ).

The most common adverse events ( 25% or more ) in patients treated with Sacituzumab govitecan in TROPiCS-02 including laboratory abnormalities, were decreased leukocyte count ( 88% ), decreased neutrophil count ( 83% ), decreased hemoglobin ( 73% ), decreased lymphocyte count ( 65% ), diarrhea ( 62% ), fatigue ( 60% ), nausea ( 59% ), alopecia ( 48% ), increased glucose ( 37% ), constipation ( 34% ), and decreased albumin ( 32% ).

The recommended Sacituzumab govitecan dose is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles until disease progression of unacceptable toxicity. ( Xagena )

Source: FDA, 2023

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