“Olaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation.”

“Nine (3%) patients in the overall study population, who were randomised on the basis of a locally identified BRCA1/2 mutation, did not go on to have their BRCA1/2 mutation confirmed as deleterious, or suspected deleterious, by the Myriad Genetics BRCA test as part of the trial. An analysis of progression-free survival that excluded these nine patients showed an HR in favour of olaparib that was highly consistent with the investigator-assessed primary endpoint. These data indicate that the progression-free survival improvement reported for patients receiving olaparib in our trial was not changed by the inclusion of patients who did not have Myriad confirmation of their BRCA1/2 mutation.”

Pujade-Lauraine E, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. The Lancet, 2017.

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Significant benefit for patients with a germline BRCA mutation and olaparib monotherapy than with standard therapy

“Among patients with HER2-negative metastatic breast cancer and a germline BRCA mutation, olaparib monotherapy provided a significant benefit over standard therapy; median progression-free survival was 2.8 months longer and the risk of disease progression or death was 42% lower with olaparib monotherapy than with standard therapy. (Funded by AstraZeneca; OlympiAD ClinicalTrials.gov number, NCT02000622.)”

Robson M, et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. NEJM 2017.

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Complementary diagnostic to Niraparib as maintenance treatment for patients with ovarian cancer

“Among patients with platinum-sensitive, recurrent ovarian cancer, the median duration of progression-free survival was significantly longer among those receiving niraparib than among those receiving placebo, regardless of the presence or absence of gBRCA mutations or HRD status, with moderate bone marrow toxicity. (Funded by Tesaro; ClinicalTrials.gov number, NCT01847274.)”

Mirza MR, et al. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. NEJM 2016.

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Postprogression PARP inhibitor treatment had a confounding influence on the interim OS analysis for BRCAm patients

“Maintenance treatment with the oral poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor olaparib (Lynparza) in Study 19 (study number, D0810C00019; ClinicalTrials.gov identifier, NCT00753545) significantly improved progression-free survival in comparison with a placebo for patients with platinum-sensitive, relapsed serous ovarian cancer with a BRCA1/2 mutation (BRCAm), but an interim analysis revealed no statistically significant overall survival (OS) benefit. However, 23% of the patients receiving the placebo switched to a PARP inhibitor after progression. To investigate whether this had a confounding effect on OS, this article reports an exploratory post hoc analysis that excluded all patients from sites where 1 or more placebo patients received postprogression PARP inhibitor treatment.”

Matulonis UA, et al. Olaparib Maintenance Therapy in Patients With Platinum-Sensitive, Relapsed Serous Ovarian Cancer and a BRCA Mutation: Overall Survival Adjusted for Postprogression Poly (Adenosine Diphosphate Ribose) Polymerase Inhibitor Therapy. Cancer 2016.

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