Roberto Iacovelli, MD, PhD, medical oncologist, the Fondazione Policlinico Gemelli IRCCS, Rome, Italy, discusses the patient eligibility criteria of the phase 2 ARIES trial (NCT03891238) in urothelial cancer.

The ARIES trial evaluated first-line avelumab (Bavencio) in patients with metastatic and locally advanced urothelial cancer who were PD-L1 positive and unfit for cisplatin-based chemotherapy.

The ideal patient for the trial had to be cisplatin ineligible and have a low creatinine clearance, Iacovelli says. Other criteria included rapid progression within 6 months from the end of adjuvant or neoadjuvant cisplatin-based chemotherapy, Iacovelli adds. A patient’s ECOG performance status needed to be 2 or less, and patients were permitted to have measurable or unmeasurable disease, Iacovelli says.

PD-L1 expression set the ARIES trial apart from other studies in metastatic and locally advanced urothelial cancer. Prior to enrollment, patients were specifically screened for PD-L1 expression on tumor cells, and only patients with a PD-L1 expression greater than 5% were eligible, Iacovelli concludes.

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Roberto Iacovelli, MD, PhD, discusses the patient eligibility criteria of the phase 2 ARIES trial in urothelial cancer.


Dr. Iacovelli on Eligibility Criteria of the ARIES Trial in Urothelial Cancer

Roberto Iacovelli, MD, PhD, medical oncologist, the Fondazione Policlinico Gemelli IRCCS, Rome, Italy, discusses the potential next steps of the phase 2 ARIES trial (NCT03891238) in urothelial cancer.

Patients who are ineligible for cisplatin represent an important portion of patients with urotherlial cancer, Iacovelli says. Results from ARIES are in line with previous studies examining immune checkpoint inhibitors in this patient population and demonstrate that immunotherapy may potentially play a role for these patients, Iacovelli explains.

Though some patients received only a few cycles of treatment, fast progression was observed on therapy, so careful selection of patients must be conducted, Iacovelli continues, adding that PD-L1 expression is not a good factor for patient selection. Otherclinical characteristics that should be implemented to maximize efficacy for patients, Iacovelli concludes.

Roberto Iacovelli, MD, PhD, discusses the potential next steps of the phase 2 ARIES trial in urothelial cancer.


Dr. Iacovelli on Next Steps of the ARIES Trial in Urothelial Cancer

Roberto Iacovelli, MD, PhD, medical oncologist, the Fondazione Policlinico Gemelli IRCCS, Rome, Italy, discusses the rationale of the phase 2 ARIES trial (NCT03891238) in urothelial cancer.

Cisplatin-based chemotherapy remains the most recommended option for most patients with advanced urothelial cancer, Iacovelli says. However, about half of patients are ineligible to receive cisplatin-based chemotherapy, Iacovelli explains. Additionally, a subgroup of patients is ineligible for all forms of chemotherapy, Iacovelli adds.

The ARIES trial focused on the specific group of patients ineligible for cisplatin-based chemotherapy, Iacovelli continues. The goal of this study was to test the activity and safety of avelumab (Bavencio) in this patient population, Iacovelli concludes.

Roberto Iacovelli, MD, PhD, discusses the rationale of the phase 2 ARIES trial in urothelial cancer.

Dr. Iacovelli on the Rationale of the ARIES Trial in Urothelial Cancer

Roberto Iacovelli, MD, PhD, medical oncologist, the Fondazione Policlinico Gemelli IRCCS, Rome, Italy, discusses efficacy findings from the phase 2 ARIES trial (NCT03891238) in urothelial cancer.

At a median follow-up of 9 months, data from the trial demonstrated a median overall survival (OS) of 10 months in all patients who received avelumab, and the estimated 1-year OS rate was 44.9%, Iacovelli says. Moreover, the median progression-free survival was 2 months.

Notably, avelumab generated an overall response rate of 22.5%. Specifically, 1 patient had a complete response, 21.1% of patients achieved a partial response, and 21.1% of patients had stable disease. These data confirmed the activity of avelumab in this patient population, Iacovelli concludes.

Roberto Iacovelli, MD, PhD, discusses efficacy findings from the phase 2 ARIES trial in urothelial cancer.


Roberto Iacovelli, MD, PhD

Articles

Dr. Iacovelli on Eligibility Criteria of the ARIES Trial in Urothelial Cancer

Dr. Iacovelli on Next Steps of the ARIES Trial in Urothelial Cancer

Dr. Iacovelli on the Rationale of the ARIES Trial in Urothelial Cancer

Dr. Iacovelli on Efficacy Findings From the ARIES Trial in Urothelial Cancer