Table 2.
Summary of clinical data for avelumab first-line maintenance treatment obtained outside of clinical trials
| Ambispective noninterventional study in France (AVENANCE)82 | Expanded access program in Italy (READY)83 | Retrospective multicenter study in the USA and Europe84 | |
|---|---|---|---|
| N | 593 | 464 | 108 |
| Median age | 73.1 years | 70.0 years | 69 years (at diagnosis) |
| ECOG PS | |||
| 0 | 31.8% | 69.6% | 55.4% |
| 1 | 53.3% | 30.4% | 41.3% |
| ≥2 | 14.9% | 0% | 3.3% |
| Creatinine clearance | Not reported | Not reported | |
| >60 ml/min | 59.8% | ||
| ≤60 ml/min | 40.2% | ||
| Primary tumor site | |||
| Lower urinary tract | 80.7% | 67.6% | 85.2% |
| Upper urinary tract | 19.3% | 32.4% | 14.8% |
| Tumor histology | |||
| Pure UC | 91.9% | 87.9% | 78.7% |
| Mixed UC | 5.4% | 10.3% | 21.3% |
| Other | 2.8% | 1.8% | 0% |
| Disease stage | Not reported | ||
| Metastatic | 91.4% | 89.6% | |
| Locally advanced | 8.6% | 10.4% | |
| First-line chemotherapy regimen | Not reported | ||
| Cisplatin + gemcitabine | 29.3% | 46.1% | |
| Carboplatin + gemcitabine | 60.9% | 51.9% | |
| Cisplatin/carboplatin switch + gemcitabine | 1.9% | 0% | |
| Dose-dense MVAC | 4.6% | 0.2% | |
| Other | 3.3% | 1.7% | |
| First-line chemotherapy regimen by platinum agent | Not reported | Not reported | |
| Cisplatin-based | 65.7% | ||
| Carboplatin-based | 34.3% | ||
| Cycles of chemotherapy received (1) | Not reported | ||
| <4 | 7.6% | 0% | |
| 4-6 | 88.6% | 99.6% | |
| >6 | 3.8% | 0.4% | |
| Cycles of chemotherapy received (2) | Not reported | ||
| ≤4 | 49.1% | 40.4% | |
| >4 | 50.9% | 59.6% | |
| Best response to first-line chemotherapy | |||
| CR | 20.3% | 11.0% | 16.7% |
| PR | 54.6% | 57.3% | 63.9% |
| SD | 22.9% | 31.7% | 19.4% |
| Other | 2.3% | 0% | 0% |
| Median interval from last chemotherapy dose to start of avelumab | Not reported | 8 weeks | 6 weeks |
| Median duration of avelumab first-line maintenance treatment | 5.8 months | 5.3 months | Not reported |
| Median follow-up | 15.2 months | 14.6 months | 8.8 months |
| OS | |||
| Median | 20.7 months | Not reached | Not reached |
| At 1 year | 65.4% | 69.2% | 72.5% |
| PFS | |||
| Median | 5.7 months | 8.1 months | 9.6 months |
| At 1 year | 35.2.% | 44.3% | Not reported |
Percentages of patients with different baseline characteristics are calculated using denominators of patients with available data.
CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; MVAC, methotrexate, vinblastine, doxorubicin (Adriamycin), and cisplatin; OS, overall survival; PR, partial response; PFS, progression-free survival; SD, stable disease; UC, urothelial carcinoma.