TEST:

Myriad myChoice® CDx Plus

P4, N=190, Active, not recruiting, Mario Negri Institute for Pharmacological Research | Recruiting --> Active, not recruiting

In summary, the results demonstrate substantial agreement and high accuracy of the NGS-based GS Focus HRD test compared to MyChoice® HRD Plus CDx. Our in-house assay is eligible for diagnostic test approval and market access as per Brazilian regulations.

Our study emphasizes the significant association between IDC-P and an elevated incidence of genetic alterations in Japanese mCSPC patients, emphasizing the need for early genetic testing to guide therapeutic decision-making.

The combination of these 3 criteria showed high specificity (0.99; 95% CI, 0.97-0.99) but low sensitivity (0.07; 95% CI, 0.04-0.10). The morphology of HGSOC correlates with HRD status and BRCA status but cannot substitute for molecular analysis in daily practice.

Liquid biopsy shows promise as a surrogate for tissue biopsy in determining HRR-gene alterations, genomic instability, and BRCA1 and RAD51C methylation statuses, albeit with some limitations.

HRD positive tumours were specifically of high-grade morphology: HGSC and carcinosarcoma. The correlation of molecular status with histological features is important in order to be able to select the cases in which analysis is required. The majority of HGSCs with SET features are HRD tumours independently of BRCA status.

Our data supports considering ascitic cytology samples suitable for HRD testing and BRCA1 and BRCA2 mutation analysis. Further studies are needed to validate the practice of using ascitic cytology as a diagnostic specimen for HRD testing when tissue is not accessible, as it could prove crucial to provide ovarian cancer patients with essential information in an early stage of the diagnostic process.

"Myriad Genetics, Inc...announced a collaboration with GSK aimed at improving access to homologous recombination deficiency (HRD) diagnostic testing for high-grade serous ovarian cancer (HGSOC) patients. A new sponsored testing program leveraging Myriad’s MyChoice HRD Plus and MyChoice CDx Plus Tests (collectively referred to as Myriad’s MyChoice Tests) is now available in Argentina, Brazil, Chile, Colombia, Egypt, Netherlands, Saudia Arabia, Singapore, and United Arab Emirates."

22 patients (48%) received PARPi (2 olaparib, 10 niraparib). Due to small sample, we did not find any statistical differences on PFS in the different subgroups. Contrary to expectations, we did observe a tendency of longer PFS in CRS1/2 versus CRS3 for BRCAmut and HRD tumors, indicating no added value for CRS in these situations. In contrast, a tendency of better PARPi response in the CRS3 versus CRS1/2 was noticed in HRP subgroup, suggesting that platinum sensitivity according to CRS could predict a better PARPi response in HRP population.

Eight centers have been activated and other 6 are waiting for the activation with 19 patients registered and 3 screening failures. The enrollment is continuing, according to protocol timeline (12 months for enrollment, 6 months for surgery and CT and 24 months for maintenance treatment).

Neoadjuvant combination treatment of olaparib and pembrolizumab showed promising efficacy and safety in patients with HRD-positive advanced ovarian cancer.

"Considering histological and sample conditions, success rates of up to 98% can be achieved. Our comprehensive evaluation contributes to further standardization of recommendations on HRD testing in ovarian cancer, which will have a large impact on personalized therapeutic strategies in this highly aggressive tumor type."