Bavencio (Avelumab) Demonstrates Sustained Overall Survival Benefit in Phase 3 Trial for First-Line Maintenance Treatment of Advanced Urothelial Carcinoma

Recently, EMD Serono, a subsidiary of Germany's Merck KGaA, announced that Bavencio (avelumab), a PD-L1 inhibitor co-developed with Pfizer, demonstrated positive long-term efficacy in a Phase 3 clinical trial for first-line maintenance treatment of urothelial carcinoma (UC). At a median follow-up time of 38 months, compared with best supportive care (BSC) alone, the combination of Bavencio as first-line maintenance therapy and BSC extended the median overall survival (OS) of patients with locally advanced or metastatic UC by 8.8 months.

Bladder cancer is the 10th most common cancer globally, with more than 500,000 new cases diagnosed in 2018 and approximately 200,000 deaths worldwide attributed to the disease. UC accounts for about 90% of all bladder cancers. It becomes more difficult to treat as the disease progresses. Platinum-based chemotherapy is currently the first-line standard treatment for advanced patients. However, most patients experience disease progression within 9 months of starting treatment. For patients with advanced UC, the five-year survival rate is only 6.4%.

Bavencio is a humanized anti-PD-L1 monoclonal antibody. Bavencio has been shown to stimulate adaptive and innate immune functions in preclinical models. Preclinical studies have shown that by blocking the interaction between PD-L1 and the PD-1 receptor, Bavencio can remove the inhibition of T-cell-mediated anti-tumor immune responses.

This Phase 3 trial showed consistent overall survival (OS) benefit in patients receiving Bavencio/BSC combination as first-line maintenance therapy compared to those receiving BSC alone, with a median follow-up of 38 months. The specific results in all patients are shown below:

• The median OS in the Bavencio/BSC group was 23.8 months (95% CI, 19.9 to 28.8), compared to 15.0 months (95% CI, 13.5 to 18.2) in the control group (HR=0.76; 95% CI, 0.631 to 0.915).
• In the Bavencio/BSC group, 43.7% of patients (95% CI, 38.2%-49.0%) were alive at 30 months, compared with 33.5% (95% CI, 28.4%-38.7%) in the control group.

In addition, in the population of tumor patients determined to be PD-L1 positive (n=358):

• The median OS in the Bavencio/BSC group was 30.9 months (95% CI, 24.0-39.8), compared to 18.5 months (95% CI, 14.1-24.2) in the control group (HR=0.69; 95% CI, 0.521-0.901).
• More than half (51.3%; 95% CI, 43.7%-58.4%) of the Bavencio/BSC group patients were alive at 30 months, compared with 38.5% (95% CI, 30.9%-46.1%) in the control group.

In terms of safety, Bavencio was consistent with previous studies, and no new safety signals were identified.

References:

[1] Long-Term Follow-Up Data Reinforce Continued Overall Survival Benefit of Bavencio® (avelumab) First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma. Retrieved February 18, 2022, from http://media.emdserono.com/2022-02-18-bavencio-bladder-100-follow-up-ASCOGU

(Original text has been abridged)

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