| pathology | Demonstrated benefit and harm | k | | | |
|---|
| lung cancer (metastatic) | versus standard of care No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| POPLAR Phase 2 atezolizumab, 2016 | atezolizumab vs docetaxel | | | overall survival 0.73 [0.53; 1.00] median 12.6 mo vs. 9.7 mo | | OAK, 2016 | atezolizumab vs docetaxel | overall survival 0.73 [0.62; 0.86] median 13.8 mo vs. 9.6 mo | | PFS 0.95 [0.82; 1.10] | | IMpower150 (WT), 2018 | atezolizumab + bevacizumab vs bevacizumab (on top platinum-based CT) | PFS 0.62 [0.52; 0.74] median 8.3 mo vs. 6.8 mo | | ORR 1.01 [0.99; 1.02] | | IMpower150 (Teff), 2018 | atezolizumab + bevacizumab vs bevacizumab (on top platinum-based CT) | PFS 0.51 [0.38; 0.68] median 11.3 mo vs. 6.8 mo | | ORR 1.00 [0.97; 1.03] |
| Trial | Treatments | Patients | Method |
|---|
| POPLAR Phase 2 atezolizumab, 2016 | Atezolizumab (n=144) vs. docetaxel 75 mg/m(2) once every 3 weeks (n=143) | patients with locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Th | open label Parallel groups Sample size: 144/143 Primary endpoint: OS FU duration: phase 2 | | OAK, 2016 | atelozumab (n=425) vs. docetaxel (n=425) | Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy | open label Parallel groups Sample size: 425/425 Primary endpoint: OS FU duration: minimum 19 months | | IMpower150 (WT), 2018 | atezo + bev + C + P; (n=356) vs. bev + C + P (n=336) 3 arms : atezo 1200 mgþC AUC 6þP 200 mg/m2 (Arm A)
or atezo
þbev 15 mg/kg þC þ P (Arm B)
versus bev þ C þP (Arm C) IV q3w for 4 or 6 cycles per
investigator (INV) discretion,
then maintenance atezo, atezo þ bev or bev, respectively. | wild type chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer (EGFR et ALK negative) | open label Parallel groups Sample size: 356/336 Primary endpoint: PFS, OS FU duration: | | IMpower150 (Teff), 2018 | atezo + bev + C + P
(n=155) vs. bev + C + P
(n=129) 3 arms : atezo 1200 mgþC AUC 6þP 200 mg/m2 (Arm A)
or atezo
þbev 15 mg/kg þC þ P (Arm B)
versus bev þ C þP (Arm C) IV q3w for 4 or 6 cycles per
investigator (INV) discretion,
then maintenance atezo, atezo þ bev or bev, respectively.
| chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer and expression of a tumour T-effector gene signature (Teff) and EGFR et ALK negative (wild type)
| open label Parallel groups Sample size: 155/129 Primary endpoint: PFS, OS FU duration:
|
|
| urothelial carcinoma (advanced) | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IMvigor210 | atezolizumab vs nil | | | |
| Trial | Treatments | Patients | Method |
|---|
| IMvigor210 | Atezolizumab (n=-9) vs. single arm study (n=-9) | Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen | Single-arm study Sample size: -9/-9 Primary endpoint: FU duration: phase 2 |
|
| urothelial carcinoma (advanced) | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IMvigor211 (IC2/3) | atezolizumab vs chemotherapy | grade 3-4 treatment-related adverse events 0.46 [0.38; 0.58] | | OS 0.87 [0.63; 1.21] median 11.1 months vs. 10.6 months ORR 1.07 [0.66; 1.73] |
| Trial | Treatments | Patients | Method |
|---|
| IMvigor211 (IC2/3) | atezolizumab (n=467) vs. chemotherapy (n=464) | patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen IC2/3 patients as planned as step 1 of the hierarchical testing | open label Parallel groups Sample size: 467/464 Primary endpoint: OS FU duration: sequential testing of IC2/3 population in first then IC1/2/3 population; and finaly all-comers population |
|
| urothelial carcinoma (advanced) | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IMVIGOR-130 (monotherapy) | atezolizumab vs control | | | |
| Trial | Treatments | Patients | Method |
|---|
| IMVIGOR-130 (monotherapy) | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin (n=-9) vs. Placebo+Gemcitabine+Carboplatin/Cisplatin (n=-9) 3rd arm with Atezolizumab Monotherapy | Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma | open-design Sample size: -9/-9 Primary endpoint: FU duration: |
|
