First-line avelumab shows clinical activity in advanced urothelial carcinoma

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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Posted on 8 April 202217 May 2024