Trodelvy (sacituzumab govitecan-hziy)

P2, N=145, Active, not recruiting, Laura Huppert, MD, BA | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Jan 2027 | Trial primary completion date: Jun 2026 --> Jan 2027

SG-induced SN and FN rates were similar to those reported in clinical trials, both in the HR + /HER- mBC and mTNBC groups. Due to small sample size, we did not identify any statistically significant risk factors of SG-associated SN. Our study provided insights into G-CSF use patterns and costs in real-world SG therapy.

P3, N=364, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Novel therapeutic approaches are emerging, including PRMT5 inhibitors in MTAP-deficient tumors, TROP-2-directed antibody-drug conjugates (e.g., sacituzumab govitecan), and chimeric antigen receptor (CAR) T-cell therapies targeting mesothelin. Bispecific agents such as bintrafusp alfa and ivonescimab, which co-target various pathways, offer innovative strategies. Despite these advances, TC remains a challenging malignancy with no standardized treatment algorithm. Collaborative efforts across institutions will be essential to accelerate progress and improve outcomes in this rare disease.

Comparative studies with a surrogate of sacituzumab govitecan were performed in TROP2-expressing tumor models...Novel anti-TROP2 ADCs offer a promising approach for assuring efficacy while potentially mitigating toxicity. Optimization of antibody binding properties may enable the development of safer and more effective TROP2-targeted therapeutics.

SG plus pembrolizumab and carboplatin had activity in mNSCLC. When combined with pembrolizumab and carboplatin, SG was tolerated at a dose of 7.5 mg/kg.

P1, N=169, Active, not recruiting, IDEAYA Biosciences | Recruiting --> Active, not recruiting

No significant association was found between TROP2 expression and other histological parameters.ConclusionLoss of ≥50% nuclear 5-hmC is a sensitive and specific marker for distinguishing mesothelioma from RMH. High TROP2 expression in tumors with high mitotic figures and higher nuclear and tumor grade suggests these patients may benefit from sacituzumab govitecan therapy.

This study defines a new mechanism of barrier-mediated immune exclusion in cancer controlled by TROP2-dependent tight junctions. This mechanism drives tumor progression but can be targeted via TROP2-directed therapy to activate antitumor immunity and enhance immunotherapy response.

By contrast, sacituzumab govitecan is a TROP-2-targeted ADC conjugated through a hydrolysable CL2A linker to SN-38, the active metabolite of irinotecan. Clinically, trastuzumab deruxtecan has shown substantial efficacy in both HER2-positive and HER2-low breast cancer, whereas sacituzumab govitecan has demonstrated efficacy across triple-negative and hormone receptor-positive/HER2-negative breast cancers. Collectively, these agents highlight how variations in target antigen, linker chemistry, and payload potency impact ADC activity, therapeutic index, and potential strategies for sequential treatment in advanced breast cancer.

P1/2, N=30, Not yet recruiting, Medica Scientia Innovation Research S.L.

P2, N=87, Not yet recruiting, National Cancer Institute (NCI)