Gilead Updates on Phase 3 TROPiCS-04 Study

Gilead Sciences, Inc. (Nasdaq: GILD), headquartered in Foster City, California, revealed the results of the Phase 3 TROPiCS-04 study, which assessed Trodelvy® (sacituzumab govitecan-hziy; SG) compared to single-agent chemotherapy in patients with locally advanced or metastatic urothelial cancer (mUC) who had previously undergone platinum-based chemotherapy and anti-PD-(L)1 therapy.

The study's primary endpoint, overall survival (OS), was not met. However, Trodelvy showed a numerical improvement in OS and positive trends in certain pre-specified subgroups and secondary endpoints like progression-free survival (PFS) and overall response rate (ORR). These subgroup analyses were not formally statistically verified. The data will be presented in a forthcoming medical meeting.

The study noted a higher incidence of deaths due to adverse events in patients treated with Trodelvy compared to chemotherapy, primarily due to early treatment-related neutropenic complications, including infections. Gilead plans to investigate these findings further and emphasize the importance of granulocyte-colony stimulating factor (G-CSF) to prevent neutropenic complications. Trodelvy carries a Boxed Warning for severe neutropenia.

The safety profile of Trodelvy, particularly for approved breast cancer indications, remains consistent and well-tolerated, as demonstrated in over 40,000 patients treated across various clinical trials. Gilead will continue data analysis and discuss future steps with the FDA. In the U.S., Trodelvy is approved for patients with locally advanced or metastatic urothelial cancer who have previously received platinum-based chemotherapy and anti-PD-(L)1 therapy. This approval is based on tumor response rates and duration, with continued approval contingent on verification of clinical benefit in confirmatory trials, including TROPiCS-04.

Metastatic urothelial cancer is a particularly aggressive disease, predominantly affecting older individuals with additional health challenges. Despite advances, survival rates are dismal, with only 8% of patients surviving beyond five years post-diagnosis. These study results underscore the difficulties in treating mUC after prior therapies, highlighting the urgent need for new treatment options to improve long-term outcomes.

Gilead expressed gratitude to the patients, families, investigators, and advocates who contributed to the research. The company remains dedicated to advancing care for the bladder cancer community. Trodelvy, the first approved Trop-2-directed antibody-drug conjugate (ADC), has shown significant survival benefits in two types of metastatic breast cancers and is currently being investigated in over 20 clinical trials.

In addition to mUC, Trodelvy is approved in nearly 50 countries for treating adult patients with advanced or metastatic triple-negative breast cancer (TNBC) and hormone receptor (HR)-positive, HER2-negative metastatic breast cancer. Trodelvy is also being explored for potential use in other cancers where Trop-2 is highly expressed, including non-small cell lung cancer (NSCLC), head and neck cancers, gynecological cancers, and gastrointestinal cancers.

U.S. safety information for Trodelvy includes warnings for severe neutropenia and diarrhea, advising withholding treatment if certain conditions are met and outlining supportive measures for managing adverse reactions. Serious hypersensitivity and infusion-related reactions have also been reported. Patients with reduced UGT1A1 activity may face increased risks of adverse reactions, and the drug can cause fetal toxicity. Common adverse reactions include decreased blood cell counts, gastrointestinal issues, and fatigue. Trodelvy interacts with UGT1A1 inhibitors and inducers, potentially altering the drug's effectiveness and safety.

Gilead Sciences continues to innovate in the biopharmaceutical sector, focusing on treatments for life-threatening diseases. The company operates globally and is committed to improving health outcomes through groundbreaking treatments.