Avelumab

A phase III study (NCT02603432) evaluated maintenance avelumab (10 mg/kg IV every 14 days) in patients with metastatic urothelial carcinoma who had not progressed during treatment with first-line chemotherapy with gemcitabine combined with either cisplatin or carboplatin. After four to six cycles of chemotherapy, 700 patients were randomly assigned to receive either best supportive care (control arm) or best supportive care plus maintenance avelumab (avelumab arm).[62][Level of evidence A1]

A phase III study (NCT02603432) evaluated maintenance avelumab (10 mg/kg IV every 14 days) in patients with metastatic urothelial carcinoma who had not progressed during treatment with first-line chemotherapy with gemcitabine combined with either cisplatin or carboplatin. After four to six cycles of chemotherapy, 700 patients were randomly assigned to receive either best supportive care (control arm) or best supportive care plus maintenance avelumab (avelumab arm).[62][Level of evidence A1]

The 1-year OS rate was 71.3% in the avelumab arm compared with 58.4% in the control arm (HR, 0.69; 95% CI, 0.56–0.86).

A phase III study (NCT02603432) evaluated maintenance avelumab (10 mg/kg IV every 14 days) in patients with metastatic urothelial carcinoma who had not progressed during treatment with first-line chemotherapy with gemcitabine combined with either cisplatin or carboplatin. After four to six cycles of chemotherapy, 700 patients were randomly assigned to receive either best supportive care (control arm) or best supportive care plus maintenance avelumab (avelumab arm).[62][Level of evidence A1]

The OS benefit was limited to patients whose tumors were PD-L1 positive. The OS in patients with PD-L1–negative tumors was not significantly different between the two arms.

A phase III study (NCT02603432) evaluated maintenance avelumab (10 mg/kg IV every 14 days) in patients with metastatic urothelial carcinoma who had not progressed during treatment with first-line chemotherapy with gemcitabine combined with either cisplatin or carboplatin. After four to six cycles of chemotherapy, 700 patients were randomly assigned to receive either best supportive care (control arm) or best supportive care plus maintenance avelumab (avelumab arm).[62][Level of evidence A1]

Patients with PD-L1–positive tumors had a 1-year OS rate of 79.1% in the avelumab arm and 60.4% in the control arm (HR, 0.56; 95% CI, 0.40–0.79).

A phase III study (NCT02603432) evaluated maintenance avelumab (10 mg/kg IV every 14 days) in patients with metastatic urothelial carcinoma who had not progressed during treatment with first-line chemotherapy with gemcitabine combined with either cisplatin or carboplatin. After four to six cycles of chemotherapy, 700 patients were randomly assigned to receive either best supportive care (control arm) or best supportive care plus maintenance avelumab (avelumab arm).[62][Level of evidence A1]

In the overall study population, the median PFS was 3.7 months for patients in the avelumab arm and 2.0 months for patients in the control arm (HR, 0.62; 95% CI, 0.52–0.75). In patients with PD-L1–positive tumors, the median PFS was 5.7 months with avelumab and 2.1 months with best supportive care alone (HR, 0.56; 95% CI, 0.43–0.73).

A phase III study (NCT02603432) evaluated maintenance avelumab (10 mg/kg IV every 14 days) in patients with metastatic urothelial carcinoma who had not progressed during treatment with first-line chemotherapy with gemcitabine combined with either cisplatin or carboplatin. After four to six cycles of chemotherapy, 700 patients were randomly assigned to receive either best supportive care (control arm) or best supportive care plus maintenance avelumab (avelumab arm).[62][Level of evidence A1]

Grade 3 or higher adverse events were reported for 47.4% of patients in the avelumab arm and 25.2% of patients in the control arm. Most adverse events with avelumab were immune related, and 9% of patients who received avelumab were treated with high-dose glucocorticoids for these events.

A study (NCT01772004) of avelumab (10 mg/kg IV every 14 days) included 249 patients with metastatic urothelial carcinoma who had progressed after treatment with platinum-based chemotherapy.[63,64][Level of evidence C3]

A study (NCT01772004) of avelumab (10 mg/kg IV every 14 days) included 249 patients with metastatic urothelial carcinoma who had progressed after treatment with platinum-based chemotherapy.[63,64][Level of evidence C3]

Among the 161 patients with at least 6 months of follow-up, the overall response rate was 17%, and response was ongoing in 23 of 28 responders with a median follow-up of 7.3 months. Six percent of the patients had a complete response.

A study (NCT01772004) of avelumab (10 mg/kg IV every 14 days) included 249 patients with metastatic urothelial carcinoma who had progressed after treatment with platinum-based chemotherapy.[63,64][Level of evidence C3]

The overall response rate was 25.0% in patients with PD-L1 expression of at least 5% and 14.7% for those with less than 5% PD-L1 positivity.

A study (NCT01772004) of avelumab (10 mg/kg IV every 14 days) included 249 patients with metastatic urothelial carcinoma who had progressed after treatment with platinum-based chemotherapy.[63,64][Level of evidence C3]

Median PFS was 6.3 weeks; 23% of the patients were progression free at 24 weeks.

A study (NCT01772004) of avelumab (10 mg/kg IV every 14 days) included 249 patients with metastatic urothelial carcinoma who had progressed after treatment with platinum-based chemotherapy.[63,64][Level of evidence C3]

A treatment-related adverse event was reported in 66.7% of patients, including 8.4% of patients with high-grade adverse events. There was one treatment-related death from pneumonitis. High-grade immune-related adverse events were reported in 2.4% of patients.