Trial results for the AUREA study (NCT04602078) investigating atezolizumab in combination with split-dose gemcitabine plus cisplatin for locally advanced or metastatic urothelial carcinoma were posted on ClinicalTrials.gov on 2025-04-24. The study reported an overall response rate (ORR) of 48.5% and a median overall survival (OS) of 12.9 months.
Background
The AUREA trial (NCT04602078) aimed to evaluate the preliminary efficacy of atezolizumab plus split-dose gemcitabine and cisplatin (GC) for the first-line setting in patients with histologically confirmed advanced (locally advanced and metastatic) urothelial cancer.
Trial design
The AUREA study (NCT04602078) was a Phase 2, multicenter, non-randomized, single-arm, open-label trial that enrolled 82 participants. The study investigated atezolizumab 1200 mg/m2 in combination with gemcitabine 1000 mg/m2 and cisplatin 70 mg/m2 in patients with locally advanced or metastatic urothelial carcinoma. The trial's primary objective was to evaluate the overall response rate (ORR) assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST).
Key results
The trial results for the AUREA single-arm study reported the following outcomes:
- The Overall Response Rate (ORR) was 48.5%.
- The median Duration of Response (DoR) was 9.2 months.
- The median Time to Response (TtR) was 2.1 months.
- The Clinical Benefit Rate (CBR) was 66.7%.
- The median Overall Survival (OS) was 12.9 months.
- The median Progression-Free Survival (PFS) was 6.9 months.
- The 6 Months Progression-Free Survival (PFS) rate was 67.6%.
Regarding safety, 66 participants experienced adverse events, and 62 participants experienced treatment-related adverse events. Subgroup analyses comparing patients with PD-L1 positive versus PD-L1 negative status showed a p-value of 0.444 using the Log Rank method and a p-value of 0.414 using the Chi-squared method.
What this means
The results from the AUREA trial provide preliminary efficacy data for atezolizumab in combination with split-dose gemcitabine and cisplatin as a first-line treatment for locally advanced or metastatic urothelial carcinoma. The observed overall response rate of 48.5% and median overall survival of 12.9 months suggest potential clinical activity for this regimen in the studied patient population. These findings contribute to the understanding of combination therapies in advanced urothelial cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04602078, titled "Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma," were posted on 2025-04-24 on clinicaltrials.gov.