(Urothelial Cancer) Avelumab Plus Best Supportive Care: Is It Effective?

• June 19, 2020
• 2 min read

From May 29–31, 2020, Thomas Powles presented at the ASCO 2020 Virtual Scientific Program the efficacy and safety results of the JAVELIN Bladder 100 Phase 3 trial evaluating avelumab (Bavencio), an anti-PD-L1 antibody, plus best supportive care (BSC) as maintenance therapy in patients with locally advanced or metastatic urothelial carcinoma who had not progressed on platinum-based chemotherapy.

The JAVELIN Bladder 100 Phase 3 trial was an open-label, international, multi-center study. Eligible patients (N=700) with locally advanced or metastatic urothelial carcinoma who did not experience disease progression after platinum-containing chemotherapy were randomized 1:1 into two groups. The primary endpoint was overall survival (OS) in all patients and in PD-L1-positive patients. Secondary endpoints included progression-free survival (PFS) in PD-L1-positive patients, anti-tumor activity, safety, pharmacokinetics, immunogenicity, biomarkers, and patient-reported outcomes:

1. Avelumab group (avelumab 10 mg/kg every 2 weeks plus BSC; N=350)
2. BSC-only group (N=350)

Results:

The primary endpoint—median OS in all patients—was 21.4 months in the avelumab group versus 14.3 months in the BSC-only group, demonstrating a statistically significant improvement. In PD-L1-positive patients, the median OS was not reached in the avelumab group versus 17.1 months in the BSC group, also showing a significant benefit.

Safety:

The overall incidence of adverse events was 98.0% in the avelumab group versus 77.7% in the BSC group. Grade 3 or higher adverse events occurred in 47.4% versus 25.2% of patients. The most common Grade 3 or higher adverse events in the avelumab group were urinary tract infection (4.4%), anemia (3.8%), hematuria (1.7%), fatigue (1.7%), and back pain (1.2%).

Conclusion:

Based on the JAVELIN Bladder 100 trial results, Thomas Powles concluded that maintenance therapy with avelumab plus BSC significantly improved the primary endpoint of OS in patients with locally advanced or metastatic urothelial carcinoma who had not progressed on platinum-based chemotherapy. The safety profile was consistent with that observed in other known clinical trials, and patients demonstrated acceptable tolerability.

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Source: Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 Phase III interim analysis. (2020 ASCO Virtual Scientific Program, Abstract LBA1)

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