Home > Oncology > ASCO GU 2022 > Urothelial Carcinoma > First-line avelumab shows clinical activity in advanced urothelial carcinoma

First-line avelumab shows clinical activity in advanced urothelial carcinoma

Presented by
Dr Roberto Iacovelli, Catholic University of Rome, Italy
Conference
ASCO GU 2022
Trial
Phase 2, ARIES
Results from the phase 2 ARIES trial showed that avelumab was clinically active and safe in cisplatin-ineligible patients with advanced urothelial cancer.

About 50% of patients with advanced urothelial cancer are considered cisplatin-ineligible [1]. Avelumab is approved as maintenance therapy after platinum-based first-line therapy for patients with advanced urothelial cancer based on the phase 3 Javelin Bladder 100 study (NCT02603432), which showed significant overall survival (OS) improvement [2].

The phase 2 ARIES trial (NCT03891238) explored the activity of avelumab as first-line therapy in cisplatin-unfit patients with advanced urothelial cancer and positive PD-L1 expression. Enrolled were 198 patients with advanced urothelial cancer who were cisplatin-unfit. Of these participants, 71 were PD-L1-positive (CPS ≥5%) and treated with avelumab until progression, unacceptable toxicity, or withdrawal, whichever occurred first. The primary endpoint was 1-year OS. Dr Roberto Iacovelli (Catholic University of Rome, Italy) presented the results [3].

After a median follow-up of 9.0 months, 13 (19%) patients were still on treatment. The median OS was 10.0 months, and 40.8% of patients were alive at 1 year. Median OS in patients with CPS ≥10% (n=56) was 13.0 months, compared with 7.0 months for patients with CPS <10% (P=0.09; see Figure). Median PFS was 2.0 months, irrespective of CPS. The ORR for all patients was 22.5% (1 complete response, 15 partial responses). The clinical benefit rate was 43.6%.

Figure: Overall survival in ARIES [3]



Avelumab showed a favourable safety profile with 30 (42%) patients reporting a grade ≥3 adverse event.

Based on these results, Dr Iacovelli concluded that first-line avelumab is clinically active and safe in patients with advanced urothelial cancer who are unfit for cisplatin-based therapy.

  1. Cathomas R, et al. Hematol Oncol Clin North Am. 2015;2:329–340.
  2. Powles T, et al. N Engl J Med 2020;383:1218–1230.
  3. Iacovelli R, et al. First line avelumab in PD-L1+ve metastatic or locally advanced urothelial cancer (aUC) patients unfit for cisplatin (cis): The ARIES trial. Abstract 439, ASCO GU 2022, 17–19 February.

 

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