Clinical Trial Results Support Genetic Testing of All Patients with Prostate Cancer

Rhea-AI Summary

Invitae (NVTA) announced findings from its PROCLAIM trial, published in European Urology Oncology, showing that 49% of prostate cancer patients with clinically actionable pathogenic/likely pathogenic germline variants could be missing out on genetics-informed care due to restrictive criteria for genetic testing.

– Research published in European Urology Oncology shows restrictive genetic testing criteria miss a significant number of prostate cancer patients with potentially actionable inherited variants –

– Offering germline testing to all prostate cancer patients could improve access to critical genetic information, particularly for historically underrepresented groups –

SAN FRANCISCO, Aug. 15, 2023 /PRNewswire/ -- Invitae (NYSE: NVTA), a leading medical genetics company, today announced findings from its PROCLAIM trial, published in European Urology Oncology, showing that almost half of prostate cancer patients with clinically actionable pathogenic/likely pathogenic germline variants (PGVs) could be missing out on genetics-informed care due to restrictive criteria for genetic testing.

In this prospective, observational study, nearly 1,000 men with prostate cancer unselected for family history of cancer, age at diagnosis or stage of disease, underwent germline genetic testing of 84 cancer predisposition genes under the care of urologists across the U.S., primarily  in community clinics. In this study, 51% of patients with prostate cancer met National Comprehensive Cancer Network (NCCN) guidelines and 49% did not. The diagnostic yield of germline genetic testing between these two patient groups was compared.

"Real world evidence suggests that less than 15% of prostate cancer patients who could benefit from genetics-informed care undergo genetic testing, in part due to complicated and prohibitive testing guidelines," said Neal Shore, M.D., F.A.C.S., from the Carolina Urologic Research Center in Myrtle Beach, South Carolina, and the principal investigator of the study. "We found no statistically significant difference in the diagnostic yield of PGVs between those who met NCCN guidelines and those who did not, suggesting there are a significant number of patients with PGVs, many of which are targets for precision therapies, who are being missed when adhering to current NCCN guidelines for genetic testing." 

Among nearly 1,000 patients (median age at diagnosis was 65 years), 65% had low-or intermediate-risk disease. A total of 77 PGVs in 17 genes were identified in 7.7% of the cohort. No significant difference was found in the prevalence of PGVs (8.8%) among the 51% of patients who met 2019 NCCN prostate criteria versus the remaining 49% who did not (6.6%), indicating that these criteria would miss 41.9% of patients with PGVs.

The data show nearly 80% of men with PGVs had potentially clinically actionable variants, including those in genes with eligibility for approved precision therapies or clinical treatment trials. When stratified by self-reported ethnicity, non-white (predominantly Black) men who were out-of-criteria had a higher number of PGVs than those who were in-criteria, suggesting current criteria disproportionately disadvantage historically underrepresented populations from obtaining critical genetic information. This disparity is particularly disturbing given Black men with prostate cancer are known to present with more aggressive disease.

"According to the American Cancer Society, prostate cancer is the second most common cancer in American men. Considering how common this diagnosis is, it's critical that individuals are offered the proper screenings and access to necessary preventive measures to assess their risk and detect cancer as early as possible," said W. Michael Korn, M.D., chief medical officer for oncology at Invitae. "Through this study, we are seeing how genetic testing can play a vital role in understanding a prostate cancer diagnosis, as it can inform different types of treatment that might work best for a patient's individual needs."

The findings support broadening the current guidelines and offering germline genetic testing to all patients with prostate cancer. This could change the standard of medical care for these patients, expanding access to precision therapies, clinical trial treatments and enhanced screening.

About Invitae 
Invitae (NYSE: NVTA) is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae's genetics experts apply a rigorous approach to data and research, serving as the foundation of their mission to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people.

To learn more, visit invitae.com and follow for updates on Twitter, Instagram, Facebook and LinkedIn @Invitae.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's beliefs regarding its clinical trial results; the company's beliefs that the results demonstrate the utility of expanding germline genetic testing guidelines; and the company's beliefs regarding the benefits of offering germline genetic testing to all prostate cancer patients, including that it could change the standard of care for these patients. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's ability to grow its business in a cost-efficient manner; the company's history of losses; the company's ability to maintain important customer relationships; the company's ability to compete; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the applicability of clinical results to actual outcomes; risks associated with litigation; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2023. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Invitae PR contact: 
Amanda McQuery
pr@invitae.com
(628) 213-3283

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SOURCE Invitae Corporation

FAQ

What did Invitae announce?

Invitae (NVTA) announced findings from its PROCLAIM trial, published in European Urology Oncology, showing that 49% of prostate cancer patients with clinically actionable pathogenic/likely pathogenic germline variants could be missing out on genetics-informed care due to restrictive criteria for genetic testing.

What is the significance of the findings from the PROCLAIM trial?

The findings from the PROCLAIM trial indicate that almost half of prostate cancer patients with clinically actionable pathogenic/likely pathogenic germline variants could be missing out on genetics-informed care due to restrictive criteria for genetic testing.

What was the aim of the PROCLAIM trial?

The PROCLAIM trial aimed to show that restrictive genetic testing criteria miss a significant number of prostate cancer patients with potentially actionable inherited variants.

What percentage of prostate cancer patients could benefit from genetics-informed care?

Less than 15% of prostate cancer patients who could benefit from genetics-informed care undergo genetic testing.

What was the diagnostic yield of germline genetic testing in the PROCLAIM trial?

The diagnostic yield of germline genetic testing between patients who met NCCN guidelines and those who did not was compared, with no statistically significant difference in the diagnostic yield of pathogenic/likely pathogenic germline variants.

What was the prevalence of pathogenic/likely pathogenic germline variants among prostate cancer patients?

The PROCLAIM trial identified 77 pathogenic/likely pathogenic germline variants in 17 genes in 7.7% of the cohort of nearly 1,000 patients.

What was the significance of the findings related to self-reported ethnicity?

The findings suggest that current criteria disproportionately disadvantage historically underrepresented populations from obtaining critical genetic information, particularly non-white (predominantly Black) men who were out-of-criteria.

What is the implication of the disparity in obtaining critical genetic information?

The disparity is particularly disturbing given Black men with prostate cancer are known to present with more aggressive disease.