Labcorp Presents New Research Demonstrating Clinical Impact of Precision Diagnostics in Guiding Biomarker-targeted Therapies for Patients with Epithelial Ovarian Cancer

Rhea-AI Summary

Labcorp presents study results at SGO Annual Meeting on Women's Cancer emphasizing the value of biomarker testing in guiding targeted therapies for ovarian cancer patients. The studies highlight the importance of comprehensive genomic profiling in improving patient outcomes and access to effective treatments.

Positive

• Labcorp showcases the significance of biomarker testing in addressing testing gaps in clinical practice.
• Studies confirm the value of combining BRCA and HRD testing to determine PARP inhibitor therapy benefits for EOC patients.
• Research underscores the impact of comprehensive biomarker testing on advancing ovarian cancer treatment and patient care.
• Findings reveal the potential of FRα testing in guiding targeted therapy for platinum-resistant EOC patients.
• High expression of Folate-receptor Alpha (FRα) in primary EOC tumors may lead to improved overall survival with targeted therapy.

Negative

• None.

Insights

Medical Research Analyst

The recent research presented by Labcorp underscores the progressive nature of biomarker testing in the clinical management of epithelial ovarian cancer (EOC). The findings suggest that a comprehensive approach, incorporating both BRCA and Homologous Recombination Deficiency (HRD) testing, could refine the selection of patients for poly-ADP ribose polymerase (PARP) inhibitors therapy. This is notable since PARP inhibitors are a significant advancement in EOC treatment, particularly for those with specific genetic mutations.

From a research perspective, the data indicating that less than half of the patients underwent HRD testing raises concerns about the underutilization of available diagnostic tools. This gap in testing could result in suboptimal treatment decisions. The differentiation in treatment continuation rates among patients with various genetic profiles highlights the potential of personalized medicine in improving patient outcomes and possibly reducing healthcare costs by avoiding ineffective treatments.

Oncology Doctor

As an oncologist, the application of these study results could be transformative for patient care. The distinction between primary and metastatic tumor sites in relation to Folate-receptor Alpha (FRα) expression is particularly noteworthy. The actionable nature of FRα as a biomarker and its overexpression in a high percentage of EOC cases points to the importance of targeted therapies like Mirvetuximab soravtansine (MIRV). The potential for MIRV to improve survival in patients with platinum-resistant EOC is a significant development in the treatment landscape.

Ensuring that healthcare providers are adequately educated on the clinical utility of these comprehensive genomic approaches is important for integrating these findings into practice. The implications for patient prognoses are profound, as the correct application of these diagnostic tools can lead to more personalized and effective treatment regimens, which is the ultimate goal in oncology.

Healthcare Economist

The economic implications of these studies are multifaceted. Firstly, the integration of biomarker testing in clinical practice could lead to more efficient allocation of healthcare resources by matching patients to the most effective therapies. This personalized approach could reduce the financial burden of ineffective treatments and the associated side effects. Secondly, the underutilization of HRD testing reveals a potential area for cost savings and improved patient care. By increasing the adherence to testing guidelines, there could be a reduction in unnecessary treatment expenses.

Long-term, the adoption of comprehensive genomic profiling may lead to a shift in healthcare spending towards more targeted, precision medicine. This could potentially improve the cost-effectiveness of cancer care, but it requires investment in provider education and infrastructure to support widespread genomic testing. As precision medicine becomes more prevalent, it will be important to monitor its impact on overall healthcare costs and patient outcomes.

Outcomes point to value of biomarker testing in addressing testing gaps in clinical practice

BURLINGTON, N.C., March 16, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today presented the results from two studies at the 2024 SGO Annual Meeting on Women's Cancer. The studies demonstrate the value of biomarker testing in closing testing gaps and guiding targeted therapies for patients with epithelial ovarian cancer (EOC).

With the rapid rate at which cancer biomarkers are being identified and new targeted therapies become available, comprehensive testing approaches are becoming even more critical as corresponding treatment guidelines evolve. Labcorp researchers conducted two studies to generate further evidence of the value of comprehensive genomic profiling to drive guideline-compliant testing that enables increased patient access to targeted therapies for improved outcomes.

Combination of BRCA testing with HRD Testing Needed to Inform Benefit of PARP Inhibitor Therapy
In one such study, conducted in partnership with Illumina, a leader in next-generation sequencing technologies, 1,093 patients diagnosed with EOC were evaluated to assess real-world clinical practice patterns for ordering BRCA and Homologous Recombination Deficiency (HRD) testing. When combined, the results of BRCA and HRD testing can determine which patients are most likely to benefit from treatment with poly-ADP ribose polymerase (PARP) inhibitors. For patients who test negative for BRCA1 and BRCA2, testing for HRD can help determine the degree of benefit from a PARP inhibitor.¹

PARP inhibitors have transformed the standard of care, especially for women with germline or deleterious somatic mutations in BRCA1 or BRCA2.² However, at least 40% of patients do not respond to PARP inhibitors, and if treated with PARP inhibitors, may experience longer treatment durations and potentially serious side effects,³ as well as increased overall costs. Treatment guidelines for PARP inhibitors emphasize the importance of diagnostic testing and individualized patient assessments.¹

Within the study population, 84% of patients underwent evaluation for BRCA mutations or HRD testing; however, less than 50% of patients underwent HRD testing. Researchers then evaluated PARP inhibitor utilization and evaluated the time to treatment discontinuation (TTD) among patients with germline/somatic BRCA mutations, tumors with HRD, and those that were homologous recombination proficient (HRP). Patients with BRCA mutations⁴ or HRD[5] tend to do well on PARP inhibitors, so testing for each can help identify patients who may be most appropriate for PARP inhibitor maintenance.

Consistent with prior prospective clinical trials, researchers reported that the median TTD of first-line PARP inhibitor maintenance therapy was the longest for patients with germline or somatic BRCA mutations or HRD tumors. Among the study groups, 77% of the patients with a germline BRCA mutation, 65.1% of patients with a somatic BRCA mutation, and 42.7% of those with HRD and BRCA wild-type continued PARP inhibitor therapy at 18 months, compared to 29% of patients in the HRP/BRCA wild-type group.

"This research emphasizes the power of comprehensive biomarker testing in advancing the treatment of ovarian cancer. By closing critical diagnostic gaps through precision testing, we are not just improving patient care but also propelling science and healthcare forward," said Shakti Ramkissoon, M.D., Ph.D., vice president, head of oncology at Labcorp. "These findings affirm that access to advanced technology, in collaboration with partners with a shared commitment to the most current care models, is the cornerstone of developing innovative diagnostic tools. These new assays can offer more patients with access to effective, biomarker-guided therapies, ultimately leading to better prognoses and opening doors to new possibilities in gynecologic oncology."

The studies are among the growing body of evidence highlighting the value of biomarker testing for EOC, specifically in real-world settings. High-grade serous epithelial ovarian cancer (HGSOC) is the deadliest of all gynecological cancers, with 70% of patients having a cancer recurrence within two to three years and almost 50% dying from the disease after five years of diagnosis.

"This research highlights the need for additional healthcare provider education on comprehensive genomic approaches and the clinical utility of guideline-driven testing to improve patient care in ovarian cancer," said Pratheesh Sathyan, head of oncology for Americas region in medical affairs at Illumina.

High Folate-receptor Alpha (FOLR1/FRα) Expression Seen in Primary EOC Tumors
In another study, Labcorp researchers evaluated real-world testing practice patterns for Folate-receptor Alpha (FRα) on primary tumors versus metastatic tumors to guide targeted therapy for patients with platinum-resistant EOC. FRα is an actionable biomarker in ovarian cancer and is overexpressed in up to 90% of EOC patients.⁶  Patients with platinum-resistant EOC whose tumors highly express FRα may be eligible for treatment with Mirvetuximab soravtansine (MIRV), the only currently available targeted therapy that improves overall survival for patients with platinum-resistant EOC.

Researchers performed a retrospective analysis of tumor samples from 432 patients with EOC undergoing standard-of-care testing via the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (developed by Roche). Of the tumor samples analyzed, 291 were from metastatic tumors, and 133 were from primary tumors. Researchers reported that 36.2% of patients had tumors that highly expressed FRα. In a critical study finding, tumor samples from primary sites were associated with higher rates of FRα positivity than those from metastatic sites.

"This study demonstrates not only the important role that FOLR1 testing can play in developing treatment strategies, but how it can help guide clinicians on the appropriate tumor sites to test to acquire the best information for that treatment guidance," said Ramkissoon.

About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in over 100 countries, worked on over 84% of the new drugs approved by the FDA in 2023 and performed more than 600 million tests for patients around the world. Learn more about us at www.labcorp.com.

---

1 Antitumor efficacy of PARP inhibitors in homologous recombination deficient carcinomas

2 Poly(ADP-Ribose) Polymerase Inhibitors in the Management of Ovarian Cancer: ASCO Guideline Rapid Recommendation Update

3 PARP Inhibitors: Clinical Limitations and Recent Attempts to Overcome Them

4 Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

5 First-line PARP inhibition in ovarian cancer — standard of care for all?

6 Final SORAYA Analysis Supports Mirvetuximab Soravtansine in Ovarian Cancer

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-presents-new-research-demonstrating-clinical-impact-of-precision-diagnostics-in-guiding-biomarker-targeted-therapies-for-patients-with-epithelial-ovarian-cancer-302090805.html

SOURCE Laboratory Corporation of America Holdings

FAQ

How many patients were evaluated in the study conducted in partnership with Illumina?

1,093 patients diagnosed with EOC were evaluated in the study conducted in partnership with Illumina.

What percentage of patients do not respond to PARP inhibitors?

At least 40% of patients do not respond to PARP inhibitors.

What is the significance of testing for HRD in patients who test negative for BRCA1 and BRCA2?

Testing for HRD in patients negative for BRCA1 and BRCA2 can help determine the degree of benefit from a PARP inhibitor.

How many patients with germline BRCA mutations continued PARP inhibitor therapy at 18 months?

77% of patients with a germline BRCA mutation continued PARP inhibitor therapy at 18 months.

What percentage of patients with tumors highly expressing FRα may be eligible for treatment with Mirvetuximab soravtansine?

Patients with tumors highly expressing FRα may be eligible for treatment with Mirvetuximab soravtansine.