Gilead's Trop-2 Antibody-Drug Conjugate Trodelvy Receives Second FDA Approval for Metastatic Urothelial Cancer

Today, Gilead Sciences announced that the U.S. FDA has granted accelerated approval for an expanded indication of Trodelvy (sacituzumab govitecan-hziy), its Trop-2-targeting antibody-drug conjugate, for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. This marks the second FDA approval for Trodelvy this year; last week, it received full FDA approval for the treatment of triple-negative breast cancer.

In 2020, approximately 580,000 people worldwide were diagnosed with bladder cancer. Urothelial carcinoma accounts for 90% of all bladder cancers and can also occur in the renal pelvis, ureters, and urethra. After failing initial platinum-based chemotherapy, 80% of patients with advanced disease do not respond to treatment with PD-1 or PD-L1 inhibitors.

Trop-2 is highly expressed in various human epithelial cancers, including breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer. Trop-2 overexpression plays a critical role in tumor growth. Furthermore, in several cancers such as breast cancer, high Trop-2 expression has been associated with more aggressive disease and poor prognosis.

Trodelvy is an antibody-drug conjugate (ADC) that links a Trop-2-targeting antibody to SN-38, the active metabolite of the chemotherapy drug irinotecan. It delivers SN-38 into cancer cells by binding to the Trop-2 protein. Notably, Everest Medicines holds the development rights for this innovative ADC in the Greater China region. It has been approved in China to conduct Phase III clinical trials for the treatment of metastatic triple-negative breast cancer and advanced urothelial carcinoma in patients who have received at least two prior lines of therapy.

This accelerated approval is based on the results of a single-arm Phase 2 clinical trial. Among 112 patients evaluable for efficacy, 27.7% achieved an objective response, including a complete response rate of 5.4%. The median duration of response was 7.2 months (95% CI: 4.7–8.6).

Note: The original text has been abridged.

References:

[1] U.S. FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer. Retrieved April 13, 2021, from https://www.businesswire.com/news/home/20210413006168/en

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