– Oral Presentation Highlights Trodelvy Efficacy of 13.5 Months Overall Survival in Patients with Platinum-Ineligible Metastatic UC After Checkpoint Inhibitor Therapy –
– Trodelvy Demonstrated 12.8 Months Overall Survival in Patients with Metastatic UC Whose Disease Progressed Rapidly Following Platinum-Based Chemotherapy –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced new and updated positive results from three cohorts of the Phase 2 TROPHY-U-01 study of Trodelvy® (sacituzumab govitecan-hziy) for the treatment of metastatic urothelial cancer (mUC). These data demonstrate that Trodelvy produced both rapid and durable responses for patients across a range of hard-to-treat types of mUC including platinum-ineligible and rapidly progressing, post-platinum mUC. These findings will be featured in both an oral session (abstract #520) and in poster presentations (abstract #518, #526) during the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) Annual Meeting February 16-18.
“The TROPHY-U-01 data show consistent benefit of Trodelvy across multiple types of metastatic urothelial cancer, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “Trodelvy has the potential to become a cornerstone treatment in metastatic urothelial cancer, and we are excited about the expected results from the ongoing Phase 3 TROPiCS-04 study that may serve to convert our U.S. accelerated approval to full approval for Trodelvy to treat patients with locally advanced or metastatic urothelial cancer following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor.”
Longer-term follow-up across Cohorts 1, 2, and 3 of TROPHY-U-01 provides an increasing body of evidence supporting the potential benefit of treating mUC with Trodelvy across clinically relevant, hard-to-treat patient populations. Results are summarized below:
|
Cohort |
Inclusion Criteria |
Key Findings |
|
Cohort 1 n=113 |
Patients with mUC who progressed after platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy
Abstract 526 |
In new long-term follow-up results, Trodelvy continued to demonstrate efficacy:
|
|
Cohort 2 n=38
|
Platinum-ineligible patients with mUC who progressed after CPI therapy
Abstract 520 |
In this primary analysis, Trodelvy demonstrated:
|
|
Cohort 3 n=41 |
Patients with rapidly progressing mUC who progressed after platinum-based therapy
Abstract 518 |
In this primary analysis, Trodelvy plus pembrolizumab, demonstrated:
|
In April 2021, the U.S. FDA granted accelerated approval of Trodelvy for use in adult patients with locally advanced or mUC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. This approval is based on ORR and DOR established in Cohort 1.
Trodelvy has not been approved by any regulatory agency for the treatment of platinum-ineligible patients with mUC who progressed after prior CPI therapy, or in combination with pembrolizumab in patients with mUC who progressed after platinum-based therapy. Its safety and efficacy have not been established for these indications.
Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information.
