Pembrolizumab

Cisplatin-ineligible and have tumors that express PD-L1 (combined positive score [CPS] of at least 10).

Cisplatin- and carboplatin-ineligible.

Progression of disease after treatment with platinum-based chemotherapy.

An open-label, international, phase III, randomized controlled trial (NCT02256436) included patients whose disease had progressed after treatment with platinum-based chemotherapy. Patients received pembrolizumab (200 mg intravenously [IV] every 21 days) or second-line chemotherapy (investigator’s choice of paclitaxel, docetaxel, or vinflunine).[43]

An open-label, international, phase III, randomized controlled trial (NCT02256436) included patients whose disease had progressed after treatment with platinum-based chemotherapy. Patients received pembrolizumab (200 mg intravenously [IV] every 21 days) or second-line chemotherapy (investigator’s choice of paclitaxel, docetaxel, or vinflunine).[43]

The median OS was longer with pembrolizumab (10.3 months vs.7.4 months; HR, 0.73; 95% CI, 0.59–0.91).

An open-label, international, phase III, randomized controlled trial (NCT02256436) included patients whose disease had progressed after treatment with platinum-based chemotherapy. Patients received pembrolizumab (200 mg intravenously [IV] every 21 days) or second-line chemotherapy (investigator’s choice of paclitaxel, docetaxel, or vinflunine).[43]

In patients with a PD-L1 CPS of at least 10, median OS was 8.0 months with pembrolizumab compared with 5.2 months of chemotherapy (HR, 0.57; 95% CI, 0.37–0.88).

An open-label, international, phase III, randomized controlled trial (NCT02256436) included patients whose disease had progressed after treatment with platinum-based chemotherapy. Patients received pembrolizumab (200 mg intravenously [IV] every 21 days) or second-line chemotherapy (investigator’s choice of paclitaxel, docetaxel, or vinflunine).[43]

The PFS rate at 12 months was 16.8% (95% CI, 12.3%–22.0%) in the pembrolizumab arm and 6.2% (95% CI, 3.3%–10.2%) in the chemotherapy arm.

An open-label, international, phase III, randomized controlled trial (NCT02256436) included patients whose disease had progressed after treatment with platinum-based chemotherapy. Patients received pembrolizumab (200 mg intravenously [IV] every 21 days) or second-line chemotherapy (investigator’s choice of paclitaxel, docetaxel, or vinflunine).[43]

The objective response rate was 21.1% in the pembrolizumab arm and 11.4% in the chemotherapy arm. Among those who responded, the median duration of response was longer than 18 months with pembrolizumab compared with a response of 4.3 months with chemotherapy.

An open-label, international, phase III, randomized controlled trial (NCT02256436) included patients whose disease had progressed after treatment with platinum-based chemotherapy. Patients received pembrolizumab (200 mg intravenously [IV] every 21 days) or second-line chemotherapy (investigator’s choice of paclitaxel, docetaxel, or vinflunine).[43]

Pembrolizumab was associated with a lower rate of treatment-related adverse events than chemotherapy (60.9% vs. 90.2%) and a lower rate of high-grade adverse events (15.0% vs. 49.4%). The most common adverse events with pembrolizumab were pruritus, fatigue, nausea, diarrhea, and decreased appetite.[43][Level of evidence A1]

A single-arm phase II trial (NCT02335424) of pembrolizumab included 370 treatment-naïve, cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.[44]

A single-arm phase II trial (NCT02335424) of pembrolizumab included 370 treatment-naïve, cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.[44]

The overall response rate was 29%. In patients with a PD-L1 CPS of at least 10, the overall response rate was 51%.

A single-arm phase II trial (NCT02335424) of pembrolizumab included 370 treatment-naïve, cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.[44]

The median duration of response had not been reached. Eighty-two percent of responses lasted at least 6 months.

A single-arm phase II trial (NCT02335424) of pembrolizumab included 370 treatment-naïve, cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.[44]

Ten percent of patients had a serious treatment-related adverse event, and one patient died of treatment-related adverse events. The most common high-grade adverse events were fatigue (2%), elevated alkaline phosphatase (1%), colitis (1%), and muscle weakness (1%).[44][Level of evidence C3]