European Commission Approves Pfizer/Merck’s Bavencio (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

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On January 25, Pfizer and Merck jointly announced that the European Commission had approved the anti-PD-L1 therapy Bavencio (avelumab) for first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress after platinum-containing chemotherapy.

Bladder cancer is the tenth most common cancer worldwide, and urothelial carcinoma (UC) is the most prevalent type of bladder cancer, accounting for approximately 90% of all cases. Metastatic UC is difficult to treat, with a 5-year survival rate of only 5%.

Notably, Bavencio is the only immunotherapy that significantly improves overall survival in the first-line treatment setting for advanced or metastatic bladder cancer. This approval will provide a new standard of care for first-line maintenance therapy for patients in Europe, helping to extend their lives.

Bavencio was first approved in the United States in June 2020 as first-line maintenance treatment for adult patients with advanced urothelial carcinoma (UC). Currently, Bavencio has been approved for this indication in 38 countries. It is under review in an additional 13 countries, including Japan, with approval expected in the first half of 2021.

The approval of this indication is based on data from the pivotal JAVELIN Bladder 100 clinical trial (NCT02603432). This was a multicenter, multinational, randomized, open-label, parallel-controlled Phase 3 study conducted in 700 patients with locally advanced or metastatic urothelial carcinoma (UC) who had not experienced disease progression following platinum-based induction chemotherapy. The study evaluated the efficacy and safety of Bavencio plus best supportive care (BSC) versus BSC alone as first-line maintenance therapy. The primary endpoints were overall survival (OS) in two key populations: all randomized patients and patients with PD-L1-positive tumors.

The results showed that at the prespecified interim analysis (data cutoff date: October 21, 2019), the study had met its primary endpoint: in both primary populations, the combination regimen of Bavencio plus best supportive care (BSC) demonstrated a statistically significant improvement in overall survival (OS) compared to BSC alone.

The specific data are as follows: (1) Among all randomized patients, the median OS was 21.4 months (95% CI: 18.9–26.1) in the Bavencio + BSC treatment group and 14.3 months (95% CI: 12.9–17.8) in the BSC treatment group; the risk of death was reduced by 31% in the Bavencio + BSC treatment group compared with the BSC treatment group (HR = 0.69; 95% CI: 0.56–0.86). (2) In the population of patients with PD-L1-positive tumors, the median OS was not reached (95% CI: 20.3 months to NE) in the Bavencio + BSC treatment group and was 17.1 months (95% CI: 13.5–23.7) in the BSC treatment group; the risk of death was reduced by 44% in the Bavencio + BSC treatment group compared with the BSC treatment group (HR = 0.56; 95% CI: 0.40–0.79).

Based on these data, the first-line maintenance regimen with Bavencio has been added to the recently updated ESMO Clinical Practice Guidelines for Bladder Cancer.

Furthermore, the latest OS results as of January 19, 2020, also demonstrated a significant prolongation of OS in the Bavencio + BSC treatment group compared with the BSC treatment group among all randomized patients (HR=0.70; 95% CI: 0.56-0.86; two-sided p=0.0008). The specific data were as follows: the median OS was 22.1 months (95% CI: 19.0-26.1) in the Bavencio + BSC treatment group and 14.6 months (95% CI: 12.8-17.8) in the BSC treatment group.

Reference Source: European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma