Secondary endpoints included PFS by homologous recombination repair deficiency....the median PFS was 9.2 months (95% confidence interval [CI]: 7.6–10.9 months), with 152 PFS events (54.5% maturity). The Table presents PFS outcomes by key subgroups.

The PFS benefit in pts with a tBRCAm and in HRD-positive pts was substantial.

Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo….The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous recombination deficiency (HRD), including tumors that had BRCA mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab.

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.

...Duration of Response, for Those Subjects With a Confirmed Response of CR or PR`CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response`Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event`Progression Free Survival`Time to Any Progression`Overall Survival`HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)...

...Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard 1st line platinum based chemotherapy treatment.`...

...Time to First Subsequent Therapy or Death (TFST)`Time to Treatment Discontinuation or Death (TDT)`PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status`Chemotherapy-free Interval (CT-FI)`Overall Survival (OS)`Percentage of Patients With Any Improvement From Baseline in Trial Outcome Index (TOI) Score at Any Point During the Treatment Period`Percentage of Patients With a 10-Point Deterioration From Baseline in TOI Score at Any Point During the Treatment Period...

...- Has documented HRD status based on available test results...

This is an open-label, multicenter pilot study evaluating the efficacy and safety of olaparib alone (cohort 1) or in combination with pembrolizumab (cohort 2) as neoadjuvant therapy in patients with HRD-positive stage III-IV ovarian cancer….Neoadjuvant olaparib monotherapy showed efficacy and tolerability in patients with HRD-positive advanced ovarian cancer.

A significant PFS benefit was seen in HRD-positive patients compared with HRD-negative ones (P = 0.0017) or in the first-line maintenance treated population (P = 0.0068).

Of 272 enrolled pts, 271 received olaparib...Consistent with the primary analysis, the 18-mo OS rate was highest in the BRCAm cohorts (similar OS in g and sBRCAm); among pts without a BRCAm, 18-mo OS was highest in the HRD +ve cohort.

A total of 181 pts were enrolled in ORZORA (BRCAm n = 145 [s n = 55; g n = 87; n = 3 s vs g status unknown]; HRRm n = 33; unassigned n = 3) . Pt characteristics were similar between s and g cohorts: ≥3 prior lines of chemotherapy (38% vs 48%, respectively); partial response to prior platinum (45% vs 49%); tumor BRCA1-mutated (65% vs 64%)....Results highlight that PSROC pts beyond those with a gBRCAm can benefit from maintenance olaparib.

As observed in the maintenance setting, similar efficacy was seen in the gBRCAm and sBRCAm cohorts. For non-BRCAm pts, longer median PFS and higher ORR were observed in the HRD+ve cohort.