high grade serous adenocarcinoma of ovary

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 . SOURCE Laboratory Corporation of America Holdings

Demonstrating Caris' impact on precision medicine, research results to be presented include the first study to report an association between clinical outcomes and molecular sub-types of uterine carcinosarcoma IRVING, Texas, March 13, 2024 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, announced today that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present three studies across multiple gynecological tumor types at the 2024 SGO Annual Meeting on Women's Cancer, March 16-18, 2024, in San Diego. The findings demonstrate the power of Caris' comprehensive multi-modal database, generated by examining every gene, to enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment. Continue Reading "We are proud to return and present an array of precision oncology research at this year's SGO Annual Meeting. The findings represent important observations in various gynecological malignancies, including the effect of molecular subtype on survival in uterine carcinosarcoma, identification of potential prognostic biomarkers in ovarian cancer, and an exploration of the frequency and outcomes of endometrial tumors with alterations in multiple molecular classifiers," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "We are confident that Caris' powerful comprehensive molecular profiling, matched clinical outcomes data and in-depth collaborative efforts within our POA member institutions will lead to novel insights into cancer biology, new targeted therapies and ultimately improved outcomes for all patients with gynecological cancers." The findings demonstrate the power of Caris' comprehensive multi-modal database, generated by examining every gene Post this Survival outcomes according to molecular classification of uterine carcinosarcoma Walking Poster Session | Walking Poster Group 5: Cancer Care Delivery March 17: 8:15 – 8:45 AM PST Uterine carcinosarcoma (UCS) is an aggressive cancer with a poor prognosis, yet there are limited studies evaluating its molecular subtypes and their association with survival outcomes. In this new study, more than 4,000 UCS and endometrioid endometrial cancer (EEC) tumors were evaluated using next-generation sequencing (NGS) to determine if UCS molecular subtype governs survival. This is the first study to report survival outcomes according to molecular classification in UCS compared to an EEC cohort. Frequency and outcomes of co-mutations according to ProMisE classifiers in endometrial cancer Poster Session I March 17: 1:15 – 1:45 PM PST The Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE) criteria classify four molecular subtypes of endometrial tumors (ET). However, there is limited understanding of how the presence of alterations in multiple classifiers affects ET prognosis. Whole exome sequencing of over 5,100 ETs revealed that some ETs have overlapping molecular subtypes. Molecular characterization of squamous cell ovarian cancers for identification of therapeutic targets Poster Session I March 17: 1:15 – 1:45 PM PST Not all ovarian cancers have the same prognosis; ovarian squamous cell carcinoma (OSCC), for example, is associated with a worse prognosis than high-grade serous ovarian cancer (HGSOC). Through NGS of DNA and RNA from ovarian tumors (OSCC, HGSOC, and Brenner's tumors), this study sought to identify prognostic factors and molecular markers associated with OSCC. High tumor mutational burden (TMB) and lack of ER, PR expression were found to be molecular characteristics of OSCC, along with other distinct patterns of molecular and immune markers. Further characterization of OSCC may lead to the identification of therapeutic targets. Poster and abstract summaries highlighting the Caris research presented at SGO 2024 will be available onsite at Caris' booth (#601). The full abstracts will be available on the Caris website beginning on March 16. The POA includes 91 cancer centers, academic institutions, research consortia and healthcare systems, including 43 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients. About Caris Life Sciences Caris Life Sciences® (Caris) is the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multi-modal database and computing capability needed to analyze and unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides an unmatched platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media Contact: Lisa Burgner [email protected] 214.294.5606 SOURCE Caris Life Sciences

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, announced an update on the status and outlook of its clinical pipeline programs. Mendus reports completion of the long-term follow up of the MERECA trial studying the intratumoral immune primer ilixadencel in metastatic renal cell carcinoma (mRCC). The long-term follow up data confirmed the observations previously reported, with no significant survival difference between the ilixadencel plus sunitinib treatment arm versus the sunitinib-only control arm of the trial. The final results of the MERECA trial confirm the decision not to pursue mRCC as a possible indication for ilixadencel. Mendus continues to explore the clinical development of ilixadencel in soft tissue sarcomas (STS) in the first half of 2024, versus earlier guidance of starting a trial before 2023YE. “The data from the MERECA trial do not support continued development in renal cell carcinoma. However, ilixadencel remains a promising product candidate for difficult-to-treat solid tumors, such as soft tissue sarcomas”, said Erik Manting, CEO of Mendus. Mendus also confirms that the Phase 1 ALISON trial with its cancer maintenance therapy vididencel in ovarian cancer is now fully recruited (17 patients). Mendus had earlier reported initial positive interim data from the ALISON trial, based on the induction of immune responses against tumor antigens previously shown to be relevant for ovarian cancer and confirming a strong safety profile for vididencel in this indication. Mendus expects further read outs of the trial in 2024, including a survival analysis in 2024H2. Mendus recently announced positive data from the Phase 2 ADVANCE II trial with its lead product vididencel in acute myeloid leukemia (AML). The data presented on December 11, 2023 at the American Society of Hematology Annual Meeting (ASH 2023), demonstrated durable clinical remissions in AML patients diagnosed with measurable residual disease (MRD). “The data with our lead product vididencel recently reported at ASH demonstrated durable clinical benefit in AML, an indication with very high unmet medical need. Mendus therefore remains focused on the regulatory path and increasing the development efforts for vididencel in AML”, Erik Manting added. As a next step in the development of vididencel in AML, Mendus has announced a collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG) to study vididencel in combination with the current standard of care in AML maintenance treatment, oral azacitidine, in a 2-stage, control-arm trial including up to 140 patients. Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/ The completed Phase 2 MERECA trial (NCT02432846) was an international, multicenter, open-label, randomized, controlled study evaluating the safety and efficacy of ilixadencel in metastatic renal cell carcinoma (mRCC). A total of 86 metastatic mRCC patients were treated, of which 56 were given ilixadencel as an intratumor administration, followed by surgery to remove the kidney tumor and standard treatment with sunitinib, and 30 patients were treated with sunitinib only. Results from the MERECA trial published earlier demonstrated that the primary endpoint of 18 months survival showed no significant differences between the ilixadencel arm and control group. Median OS was 35.6 months for the ilixadencel arm, as compared to 25.3 months in the control group1. At completion of the long-term follow-up period of 5 years post-treatment of last patient enrolled, there was no significant survival difference between the two treatment arms, with 32.1% of patients alive in the ilixadencel arm, as compared to 26.7% in the control arm. The MERECA trial data do not support the development of ilixadencel in mRCC. The Phase 1 ALISON trial (NCT04739527) is a single-center, open-label study evaluating safety and efficacy of vididencel (DCP-001) in high-grade serous ovarian cancer (HGSOC) patients. The ALISON trial evaluates the use of vididencel as a maintenance immunotherapy, aimed to prolong disease-free survival following primary treatment comprising debulking surgery and chemotherapy. The primary endpoint of the trial is the number of patients with vididencel-induced antigen-specific T cells responses in peripheral blood after treatment. Key secondary endpoints include safety and tolerability after repeated vididencel dosing, as well as recurrence free survival (RFS) and overall survival (OS) during a 2-year follow-up period. Patient enrolment (17) has been completed and further analysis of vididencel-induced immune responses, safety and potential survival benefit will continue in 2024. The Phase 2 ADVANCE II trial (NCT03697707) is an international, multicenter, open-label study evaluating safety and efficacy of vididencel (DCP-001) in acute myeloid leukaemia (AML). Patients were in remission following chemotherapy, but diagnosed with persistent measurable residual disease (MRD). Patients received four biweekly doses of vididencel, followed by additional booster administrations at weeks 14 and 18. Blood and tissue samples were collected for assessments of MRD and immune response monitoring. The active study phase comprising a 70-week follow-up period from the start of vididencel treatment was completed and patients are now in long-term follow up. As per the most recent read-out November 24, 2023, the median follow-up for the entire study population was 31.6 months. Median RFS stood at 30.4 months and median OS was not reached, with 14/20 patients still alive and 11 still in remission at the cut-off date. The RFS at 2 years was 56%, and the estimated 2-year and 3-year OS stood at 74.9% and 64.7%, respectively. Reduction in MRD and induction of immune responses was associated with RFS and OS benefit, confirming the vididencel mechanism of action as an immunotherapy which improves immunity against residual cancer cells. Vididencel treatment was generally well-tolerated and safe, with drug-related adverse events limited to injection-site reactions and no reported drug-related serious adverse events. The positive ADVANCE II data support the continued development of vididencel in AML. The content above comes from the network. if any infringement, please contact us to modify.