| lung cancer (metastatic) | superior to placebo in terms of PFS in PACIFIC, 2017 (maintenance patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PACIFIC, 2017 | vs placebo | PFS 0.52 [0.42; 0.65] median 16.8 mo vs. 5.6 mo Demonstrated | | | | ARCTIC PD-L1 negative, 2018 | vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| PACIFIC, 2017 | Durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) every 2 weeks for up to 12 months, administered 1 to 42 days after the patients had received chemoradiotherapy (n=473) vs. placebo (n=236) | patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy | double-blind Parallel groups Sample size: 473/236 Primary endpoint: PFS, OS FU duration: | | ARCTIC PD-L1 negative, 2018 | combination of MEDI4736 (durvalumab) plus tremelimumab (n=-9) vs. Standard of Care
(n=-9)
| patients with PD-L1 negative Locally Advanced or Metastatic Non Small Cell Lung Cancer who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC
| Sample size: -9/-9 Primary endpoint: Overall Survival , FU duration:
|
|
| urothelial carcinoma (advanced) | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| durvalumab phase 1/2 | vs nil | | | |
| Trial | Treatments | Patients | Method |
|---|
| durvalumab phase 1/2 | durvalumab at 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity (n=-9) vs. (n=-9) | patients with locally-advanced or metastatic urothelial carcinoma of the bladder who had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting | Single-arm study Sample size: -9/-9 Primary endpoint: FU duration: phase 1/2 |
|
