Gilead Sciences has reported positive results from a phase 2 trial of its Trop-2 directed antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) in urothelial cancer (UC), the most common type of bladder cancer.
An estimated 83,000 Americans will be diagnosed with bladder cancer in 2023 and almost 90% of those diagnoses will be for UC.
Around 30% of cases are considered advanced or metastatic and, despite advances in treating metastatic UC (mUC), long-term survival remains low.
Longer-term follow-up results across the three cohorts included in Gilead’s ongoing TROPHY-U-01 provide increasing evidence supporting the potential benefit of treating mUC with Trodelvy across hard-to-treat patient populations.
In cohort one, which assessed mUC patients whose cancer had progressed after platinum-based chemotherapy and checkpoint inhibitor therapy (CPI), Trodelvy was associated with a 10.9 months median overall survival, as well as a 28% overall response rate.
An 8.2 months median duration of response and 5.4 months median progression-free survival was also observed in the group.
Cohort two, which included platinum-ineligible patients with mUC who progressed after CPI therapy, demonstrated a median overall survival of 13.5 months, a 32% overall response rate, a 5.6 months median duration of response and 5.6 months median progression-free survival.
Similar results were seen across cohort three, which observed patients with rapidly progressing mUC who progressed after platinum-based therapy, including a 12.8 months of median overall survival and a 41% overall response rate.
Bill Grossman, senior vice president and therapeutic area head at Gilead Oncology, said: “The TROPHY-U-01 data shows consistent benefit of Trodelvy across multiple types of mUC, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce.”
The drug has already received accelerated approval for patients with locally advanced or mUC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.
“Trodelvy has the potential to become a cornerstone treatment in mUC, and we are excited about the expected results from the ongoing phase 3 TROPiCS-04 study that may serve to convert our US accelerated approval to full approval for Trodelvy,” Grossman added.
The drug is currently approved in over 40 countries to treat certain patients with breast cancer, and is being developed for potential investigational use in a range of tumour types where Trop-2 is highly expressed, including metastatic lung cancers, head and neck cancer and endometrial cancer.