Clinical trials of olaparib - TrialResults-center.org

pathology

Benefit (demonstrated or suggested) and harm

advanced breast cancer (metastatic)

superior to Physician s choice chemotherapy in terms of PFS in OlympiAD, 2017

Trial	control	p<0.05	harm	NS
OlympiAD, 2017	vs Physician s choice chemotherapy	PFS 0.58 [0.43; 0.79] Demonstrated		OS 0.90 [0.63; 1.29]

Trial

Treatments

Patients

Method

OlympiAD, 2017

Olaparib (Olaparib tablet 300mg bd po) (n=205)

vs.

Physician's 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) (n=97)

women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation

open label

Sample size: 205/97

Primary endpoint: Progression Free Survival

FU duration: 14.5 months

ovarian cancer

All results are NS for efficacy

meta-analysis

Trial	control	p<0.05	harm	NS
Ledermann, 2012	vs placebo	PFS 0.35 [0.25; 0.49] median 8.4 mo vs. 4.8 mo		OS 0.94 [0.63; 1.40]
SOLO2/ENGOT-Ov21	vs placebo	PFS 0.30 [0.22; 0.41] median 19.1 months vs. 5.5 months

Trial

Treatments

Patients

Method

Ledermann, 2012

olaparib, at a dose of 400 mg twice daily (n=136)

vs.

placebo (n=129)

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

double-blind

Sample size: 136/129

Primary endpoint:

FU duration:

phase 2

SOLO2/ENGOT-Ov21

olaparib 300 mg in two 150 mg tablets, twice daily (n=196)

vs.

placebo (n=99)

patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation

double-blind

Sample size: 196/99

Primary endpoint: investigator-assessed progression-free survival

FU duration:

Olaparib poly ADP-ribose polymerase (PARP) inhibitor Description Results

Group by...

Olaparib poly ADP-ribose polymerase (PARP) inhibitor
Description Results