Summary

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• Trodelvy (sacituzumab govitecan-hziy) is 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; for the treatment of adult 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; and for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
• This summary is based on the review of four systematic review(s)/meta-analysis(es). ^[1-4]
• Sacituzumab govitecan (SG) achieved a Complete Response (CR) rate of 4.9% (95% CI: 3.2-7.1), a Partial Response (PR) rate of 35.6% (95% CI: 31.5-39.9), and an Objective Response Rate (ORR) of 6.8% (95% CI: 5.9-7.8), with stable disease in 8.0% (95% CI: 6.7-9.4) of patients.
• SG demonstrated superior Progression-Free Survival (PFS) with a Hazard Ratio (HR) of 0.41 (95% CI: 0.32-0.52) compared to the physician's choice, and a HR of 0.55 (95% CI: 0.51-0.61) in triple-negative breast cancer (TNBC) randomized controlled trials (RCTs).
• SG also improved Overall Survival (OS) with a HR of 0.48 (95% CI: 0.39-0.60) compared to the physician's choice, and a HR of 0.59 (95% CI: 0.54-0.66) in TNBC RCTs, positioning it as the best advanced-line treatment in terms of PFS and OS in the specified populations.
• Adverse Events Associated with SG: Neutropenia, fatigue, anemia, and nausea were reported as adverse events in patients receiving sacituzumab govitecan.
• Grades 3 to 5 Adverse Reactions: Higher incidences of neutropenia and leukopenia, with lower incidences of fever, headache, hypertension, and rash were observed. Specific grade ≥3 adverse events included anemia (4%), rash (1%), diarrhea (2%), fatigue (1%), hypertension (2%), thrombocytopenia (9%), and elevated aminotransferases (3%).
• SG demonstrated superior effectiveness in progression-free survival (HR: 0.41, 95% CI: 0.32-0.52) and overall survival (HR: 0.48, 95% CI: 0.39-0.60) in metastatic triple-negative breast cancer (mTNBC) patients, particularly in relapsed/refractory mTNBC, compared to the physician's choice treatment. Comparable efficacy was observed for PARP-inhibitors in germline-BRCA1/2-mutant tumors and for immunotherapy combined with chemotherapy in PD-L1-positive mTNBC.