How effective is Trodelvy?

Trodelvy (sacituzumab govitecan-hziy) is a targeted chemotherapy drug that may be used to treat the following cancers that have spread (metastasized) or cannot be removed by surgery:

• triple-negative breast cancer (negative for estrogen and progesterone hormone receptors and HER2 [TNBC]) who have received at least 2 prior treatments, including at least one for metastatic disease.
• hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who have previously received endocrine therapy and at least 2 additional treatments for metastatic disease
• bladder cancer and cancers of the urinary tract who have received a platinum containing chemotherapy medicine and an immunotherapy medicine.

Treatment with Trodelvy aims to increase the length of time a patient lives, and also how long they live without their cancer progressing. For most of these cancers, few other treatments are available.

How effective is Trodelvy for triple-negative breast cancer?

In patients with TNBC, whose cancer had not spread to the brain, treatment with Trodelvy resulted in significantly longer progression-free survival (5.6 vs. 1.7 months) and overall survival (12.1 vs. 6.7 months) compared with patients treated with the physician’s choice of single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine), according to the results of the phase III ASCENT trial.

More of the patients in the ASCENT trial treated with Trodelvy also successfully responded to treatment compared with patients who received single-agent chemotherapy (35 vs. 5 percent). In a separate study called IMMU-132-01, which enrolled 108 patients with TNBC who had received between 2 and 10 previous treatments, 33.3 percent of patients responded to treatment with Trodelvy. Median progression-free survival and overall survival in these patients was 5.5 and 13 months, respectively.

How effective is Trodelvy for pre-treated HR+/HER2- metastatic breast cancer?

A statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months was reported for Trodelvy vs. single-agent chemotherapy (treatment of physician’s choice; TPC) (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02) in the TROPiCS-02 study. Trodelvy also demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.66; 95% CI: 0.53-0.83; p=0.0003). Three times as many people treated with Trodelvy were progression-free at one year versus those treated with chemotherapy (21% versus 7%). Secondary endpoint measures, including objective response rate and time to deterioration (TTD), were also significantly improved by Trodelvy.

Trodelvy is now recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN).

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How effective is Trodelvy for urothelial cancer?

In patients with locally advanced, unresectable (unable to be removed by surgery), or metastatic (has spread) urothelial carcinoma - whose cancer has worsened while on platinum-based combination therapy and checkpoint inhibitors - treatment with Trodelvy resulted in median progression-free survival and overall survival times of 5.4 months and 10.9 months, respectively, according to the results of the TROPHY-U-01 trial. A median overall survival time of 7-8 months is usual in these patients.

A total of 27 percent of the 113 patients enrolled in cohort 1 of the TROPHY-U-01 trial also successfully responded to treatment (objective response rate). The expected response rate in these patients without Trodelvy is about 10 percent.

Does Trodelvy shrink tumors?

Trodelvy may shrink the size of your tumors. Of the 27 percent of patients who responded to treatment in the TROPHY-U-01 trial conducted in patients with urothelial cancer, about 5 percent had their tumors completely disappear (complete response), and about 22 percent had a partial response that saw their tumors decrease in size by at least 30 percent.

In the ASCENT trial conducted on patients with TNBC, about 4 percent had their tumors completely disappear (complete response) and about 31 percent had a partial response.

In addition to the patients who benefit from the tumor-shrinking effects of Trodelvy, other patients also derive a clinical benefit from taking this drug because it keeps their disease stable - meaning that their tumors stay about the same size for some time instead of getting worse.

Trodelvy has been approved by the US Food and Drug Administration (FDA) to treat:

• TNBC that has spread or is locally advanced and unable to be removed with surgery in people who have been treated with two or more other therapies, including at least one for treating metastatic disease
• 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
• Urothelial cancer that has spread or is locally advanced, in people who have already received treatment with platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor.