| Niraparib | ovarian cancer, in all type of patient (BRCA mutated or not) | vs placebo | progression or death (progression free survival PFS) by 62% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.38 [0.30 0.49] | p=0.04 | 0 | 406 | 2 | ENGOT-OV16/NOVA non-gBRCA, ENGOT-OV16/NOVA gBRCA, |
| Trial | Studied treatment | Control | Patients |
|---|
| ENGOT-OV16/NOVA non-gBRCA, | niraparib (300 mg) once daily | placebo | patients with platinum-sensitive, recurrent ovarian cancer | | ENGOT-OV16/NOVA gBRCA, 2017 | niraparib (300 mg) once daily as maintenance treatment | placebo
| patients with platinum-sensitive, recurrent ovarian cancer with germline BRCA mutation
|
| |
| Niraparib | ovarian cancer, in patients without BRCA mutation | vs placebo | progression or death (progression free survival PFS) by 55% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.45 [0.33 0.61] | p=0.04 | 0 | 203 | 1 | ENGOT-OV16/NOVA non-gBRCA, |
| Trial | Studied treatment | Control | Patients |
|---|
| ENGOT-OV16/NOVA non-gBRCA, | niraparib (300 mg) once daily | placebo | patients with platinum-sensitive, recurrent ovarian cancer |
| |
| Niraparib | ovarian cancer, in patients with BRCA mutation | vs placebo | progression or death (progression free survival PFS) by 73% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.27 [0.17 0.42] | p=0.04 | 0 | 203 | 1 | ENGOT-OV16/NOVA gBRCA, |
| Trial | Studied treatment | Control | Patients |
|---|
| ENGOT-OV16/NOVA gBRCA, 2017 | niraparib (300 mg) once daily as maintenance treatment | placebo
| patients with platinum-sensitive, recurrent ovarian cancer with germline BRCA mutation
|
| |
| Olaparib | advanced breast cancer (metastatic), in all type of patients | vs Physician s choice chemotherapy | progression or death (progression free survival PFS) by 42% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | 0.90 [0.63 1.29] | p=1.00 | 0 | 302 | 1 | OlympiAD, | | progression or death (progression free survival PFS) | 0.58 [0.43 0.79] | p=0.04 | 0 | 302 | 1 | OlympiAD, | | treatment discontinuation due to toxic effects | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| OlympiAD, 2017 | Olaparib (Olaparib tablet 300mg bd po) | Physicians choice chemotherapy (Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21) | women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation |
| |
| Olaparib | advanced breast cancer (metastatic), in BRCA-mutated | vs Physician s choice chemotherapy | progression or death (progression free survival PFS) by 42% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | 0.90 [0.63 1.29] | p=1.00 | 0 | 302 | 1 | OlympiAD, | | progression or death (progression free survival PFS) | 0.58 [0.43 0.79] | p=0.04 | 0 | 302 | 1 | OlympiAD, | | treatment discontinuation due to toxic effects | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| OlympiAD, 2017 | Olaparib (Olaparib tablet 300mg bd po) | Physicians choice chemotherapy (Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21) | women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation |
| |
| Olaparib | advanced breast cancer (metastatic), in HER 2 negative | vs Physician s choice chemotherapy | progression or death (progression free survival PFS) by 42% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | 0.90 [0.63 1.29] | p=1.00 | 0 | 302 | 1 | OlympiAD, | | progression or death (progression free survival PFS) | 0.58 [0.43 0.79] | p=0.04 | 0 | 302 | 1 | OlympiAD, | | treatment discontinuation due to toxic effects | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| OlympiAD, 2017 | Olaparib (Olaparib tablet 300mg bd po) | Physicians choice chemotherapy (Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21) | women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation |
| |
| Olaparib | ovarian cancer, in all type of patient (BRCA mutated or not) | vs placebo | progression or death (progression free survival PFS) by 68% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | 0.94 [0.63 1.40] | p=1.00 | 0 | 265 | 1 | Ledermann, | | progression or death (progression free survival PFS) | 0.32 [0.26 0.40] | p=0.04 | 0 | 560 | 2 | Ledermann, SOLO2/ENGOT-Ov21, |
| Trial | Studied treatment | Control | Patients |
|---|
| Ledermann, 2012 | olaparib, at a dose of 400 mg twice daily | placebo | patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer with or without BRCA1 or BRCA2 germline mutations, who had received two or more platinum-based regimens and had had a partial or complete response to their most recent platinum-based regimen | | SOLO2/ENGOT-Ov21, | olaparib 300 mg in two 150 mg tablets, twice daily | placebo | patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation |
| |
| Olaparib | ovarian cancer, in patients with BRCA mutation | vs placebo | progression or death (progression free survival PFS) by 70% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.30 [0.22 0.41] | p=0.04 | 0 | 295 | 1 | SOLO2/ENGOT-Ov21, |
| Trial | Studied treatment | Control | Patients |
|---|
| SOLO2/ENGOT-Ov21, | olaparib 300 mg in two 150 mg tablets, twice daily | placebo | patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation |
| |
