Outcomes for trials involving the targeting of the PD-1/PD-L1 axis
| Clinical trial identification/reference | Clinical setting | Treatment setting | Outcome(s) |
|---|---|---|---|
| NCT02632409/Bajorin et al. [29] | Patients with muscle-invasive urothelial carcinoma who had undergone radical surgery. | 240 mg nivolumab or placebo was administered every 2 weeks for up to 1 year. Neoadjuvant cisplatin-based chemotherapy before trial entry was allowed. | Patients showed a median disease-free survival of 10.8 and 20.8 months when treated with placebo and nivolumab, respectively. Patients who were alive and free from recurrence outside the urothelial tract at 6 months were found to be 77.0% with nivolumab and 62.7% with placebo. |
| NCT02256436/Bellmunt et al. [30] | Patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy. | Patients were administered a dose of 200 mg pembrolizumab every 3 weeks or the investigator’s choice of chemotherapy with paclitaxel, docetaxel, or vinflunine. | The median overall survival in the total population was 10.3 months in the pembrolizumab group, as compared to 7.4 months in the chemotherapy group. |
| NCT04223856/Powles et al. [31] | Patients with unresectable locally advanced or metastatic urothelial carcinoma. | Patients were administered 3-week cycles of enfortumab vedotin (at a dose of 1.25 mg per kilogram of body weight intravenously on days 1 and 8) and pembrolizumab (at a dose of 200 mg intravenously on day 1) or gemcitabine and either cisplatin or carboplatin (determined on the basis of eligibility to receive cisplatin). | Progression-free survival was longer in the enfortumab vedotin-pembrolizumab group than in the chemotherapy group at a median of 12.5 months versus 6.3 months, respectively. Overall survival was longer in the enfortumab vedotin-pembrolizumab group than in the chemotherapy group at a median of 31.5 months versus 16.1 months, respectively. |
| NCT02387996/Sharma et al. [32] | Patients with metastatic or surgically unresectable locally advanced urothelial carcinoma. | Patients received nivolumab 3 mg/kg intravenously every 2 weeks until disease progression and clinical deterioration, unacceptable toxicity, or other protocol-defined reasons. | Overall survival was found to be a median 7.0 months. |
| NCT03891238/Iacovelli et al. [33] | Patients with metastatic urothelial carcinoma who were ineligible for cisplatin-based chemotherapy that were screened centrally for PD-L1 expression and only those with a tumour proportion score ≥ 5%. | Patients received 10 mg/kg avelumab intravenously every 2 weeks until disease progression, intolerable toxicity, or a decision to withdraw by the clinician/patient. | The median overall survival was 10.0 months and 43% of patients were alive at 1 year. |
| NCT02603432/Powles et al. [34] | Patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of gemcitabine plus cisplatin or carboplatin) to receive best supportive care with or without maintenance avelumab. | Patients received either maintenance therapy with avelumab at a dose of 10 mg per kilogram of body weight, administered intravenously every 2 weeks plus best supportive care or best supportive care alone. | Overall survival at 1 year was 71.3% in the avelumab group and 58.4% in the control group. Median overall survival was 21.4 months in the avelumab group and 14.3 months in the control group. |
| NCT04624399/Castellano et al. [35] | Patients were in disease stages prior to cystectomy in non-urothelial muscle-invasive bladder cancer | Patients received 2 cycles of atezolizumab 1200 mg once every three weeks prior to cystectomy. | The pathological complete response rate in pT2 or above patients was 38% (8/21), and 35% (8/23) including pT1 patients. |
PD-1/PD-L1: programmed cell death protein 1/programmed death ligand 1
