Serous Cystadenocarcinoma

Phase 1 analysis from the PYNNACLE Phase 1/2 study showed promising efficacy of rezatapopt (PC14586) in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation featured in a late-breaking oral presentation at 2024 SGO Annual Meeting Of the 15 patients in the efficacy evaluable population, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile Rezatapopt is a first-in-class precision oncology investigational therapy in patients with advanced solid tumors with a TP53 Y220C mutation and KRAS wild-type which is being evaluated in a registrational Phase 2 study March 18, 2024 -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that a Phase 1 analysis reported promising anti-tumor activity of rezatapopt (PC14586) in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation. Rezatapopt is a first-in-class precision oncology small molecule investigational therapy that selectively targets the TP53 Y220C mutation in solid tumors. These data were featured today in a late-breaking oral presentation at the 2024 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer being held March 16-18, 2024 in San Diego, CA. The presentation entitled, “Phase 1 Analysis from the PYNNACLE Phase 1/2 Study PC14586 in the Subgroup of Patients with Advanced Ovarian Cancer Harboring a TP53 Y220C Mutation,” was delivered by Alison M. Schram, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center. “In this Phase 1 study, we observed promising efficacy of rezatapopt in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation. In addition, rezatapopt showed a favorable safety profile,” said Dr. Schram. “These data are encouraging given the significant unmet medical need for patients with advanced solid tumors, particularly in patients with ovarian cancer who are platinum resistant. Further study of rezatapopt as monotherapy in ovarian cancer is warranted.” Deepika Jalota, Pharm.D., Chief Development Officer of PMV Pharma added, “These Phase 1 PYNNACLE data presented at the SGO meeting showed that rezatapopt, a first-in-class precision oncology investigational therapy, continues to demonstrate clinical benefit in a patient population of high unmet need. Our registrational, tumor-agnostic PYNNACLE Phase 2 trial, which includes an ovarian cancer cohort, remains on track to initiate in the first quarter of this year. The trial will assess rezatapopt as monotherapy at the recommended Phase 2 dose of 2000 mg daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors.” Phase 1 data from the PYNNACLE trial (NCT04585750) demonstrated that rezatapopt has a favorable safety profile and induced responses in heavily pre-treated patients across multiple tumor types. This subgroup analysis investigated the efficacy of rezatapopt in patients with advanced ovarian cancer treated across the efficacious dose range (1150 mg daily to 1500 mg twice daily). As of September 5, 2023, the median age of patients with ovarian cancer (N=22) was 66 years (range 49 – 81 years) At baseline, 20 patients had high-grade serous ovarian cancer and two had endometrioid cancer Nineteen patients were platinum resistant and one was platinum refractory Two patients had a BRCA2 mutation Six patients were homologous recombination deficiency positive All patients were KRAS wild-type Median number of prior lines of systemic therapy was four (range 1 – 9) Efficacy The efficacy evaluable population consisted of 15 patients with measurable disease at baseline and ≥1 post-baseline tumor assessment. Seven patients achieved a confirmed partial response (PR), seven had stable disease (SD), and one had progressive disease Median duration of response was seven months Of the 15 patients with measurable serum CA-125 at baseline, six had a CA-125 response. Among these, five patients achieved radiographic PR and one had SD Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. The ongoing Phase 1/2 PYNNACLE study is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers will also be assessed. Phase 2 will be an expansion study with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750). PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. p53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit www.pmvpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Findings presented at SGO 2024 show 87% of respondents afraid of making long-term plans due to the possibility of a shorter life expectancy 84% say dealing with treatment side effects has negatively impacted their emotional well-being, and 94% worry about LGSOC returning despite treatment BOSTON--(BUSINESS WIRE)-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced new results from the first-ever global LGSOC Patient Impact Survey, developed with patient advocates and community medical leaders to better understand and address the complex needs and experiences of those living with low-grade serous ovarian cancer (LGSOC). The results reveal a significant negative impact of LGSOC on respondents’ mental and physical health, worry and anxiety about cancer recurrence, side effects from treatment, and disruption to aspects of daily life such as relationships, family, work, and finances. These findings will be presented as a poster presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, March 16-18 in San Diego, California. Key findings showed that most of those surveyed (87%) reported being afraid to make long-term plans due to concerns about the possibility of a shorter lifespan, and 60% reported a negative impact of LGSOC on their plans to start a family or have more children. Findings also highlight burdensome treatment concerns, with 94% of respondents worried that their LGSOC would return despite treatment and 84% reporting that a treatment side effect has negatively impacted their emotional well-being. Other impacts that were noted by survey respondents include, negative effects on their mental health (73%), physical health (80%), overall quality of life (73%), finances (54%) and primary relationships (46%). “For many people, a diagnosis of LGSOC brings a set of unique challenges. What is often not understood is that standard-of-care chemotherapies are minimally effective and often accompanied by severe side effects. Even if patients achieve remission, there is still a high risk of the disease recurring,” said Dr. David Gershenson, expert researcher in rare ovarian cancers, LGSOC Patient Impact Survey Advisory Committee member and senior study author. “These survey results reinforce what we’ve observed in clinical practice ― that this disease takes a high toll on mental health and quality of life and can disrupt relationships, family life and financial security. Our efforts must focus on identifying effective ways to help people cope with the worry, fear of recurrence and treatment-related side effects that they experience with LGSOC, alongside our work to develop treatments for this rare and challenging cancer.” LGSOC is a rare, highly recurrent, and fatal ovarian cancer characterized by persistent tumor growth that requires continuous treatment; 85% percent of people with LGSOC have their cancer come back after remission. It often affects younger women and can be diagnosed as early as the 20s and 30s, with a median age of diagnosis around 45. Widespread awareness and understanding of specific patient needs remain low. People with LGSOC have few available treatment options, and there is no FDA-approved treatment specifically for LGSOC. “Having navigated my own journey with LGSOC and connecting with so many others impacted by this disease, the findings of this survey reinforce the sad but very real truth: the burdens of LGSOC encompass every aspect of life after a diagnosis,” said Nicole Andrews, Board of Directors Chair, STAAR Ovarian Cancer Foundation and a member of the LGSOC Patient Impact Survey Advisory Committee. “These findings underscore the critical need for comprehensive support systems that address not only the medical challenges of LGSOC but also the emotional, social, and financial burdens placed on patients. The LGSOC journey is filled with uncertainty and isolation, and it is only through holistic support that we can ease this path and bolster hope for all those affected.” Impacts of LGSOC on Daily Life According to the survey, the impacts of LGSOC extend beyond health concerns, affecting many aspects of a person’s life, including their social and emotional well-being, employment and finances. 61% of respondents found it hard to relate to other women their age, and 56.5% didn’t feel they had anyone they could talk to about LGSOC. 46% of respondents said LGSOC has negatively impacted their romantic relationships (e.g., spouse, partner, dating), and 32% reported negative impacts on relationships with family and friends. 68% of respondents reported a negative impact on their jobs or careers, with 52% missing work to manage their cancer and 23% having to cut back on necessities to afford treatment. Biggest challenges reported by people with LGSOC were living with the uncertainty of cancer recurrence (68%), having limited treatment options (60%), and dealing with side effects from treatment (52%). The factors most closely associated* with a negative mental health impact were difficulty with treatment-related side effects (OR=5.0, 95% CI 1.46-17.0), constant worry about LGSOC (OR=4.03, 95% CI 1.53-10.62), financial challenges (OR=2.57, 95% CI 1.02-6.45), and having no one to talk to about their disease (OR=2.55, 95% CI 1.02-6.40). * Reported as an odds ratio (OR) About the LGSOC Patient Impact Survey The LGSOC Patient Impact Advisory Committee, which included the STAAR Ovarian Cancer Foundation (STAAR), Cure Our Ovarian Cancer, and the World Ovarian Cancer Coalition (Coalition), as well as community medical leaders, supported by Verastem Oncology, worked with The Harris Poll to conduct a survey on behalf of leaders in the medical and advocacy communities. They surveyed women ages 18+ who have been diagnosed with LGSOC across 10+ countries. The survey was conducted July 31st - August 29th, 2023, examining the particular challenges with diagnosis and disease management experienced by people living with LGSOC. A total of 186 women completed surveys. Initial findings from the survey were announced in November 2023. Women were recruited through patient advocacy group websites, emails, newsletters, and social media. Questions focused on perceived barriers to diagnosis and disease management, financial concerns, impact on mental and physical health, and key challenges and concerns. Raw data were not weighted and are therefore only representative of the individuals who completed the survey. The sampling precision of Harris online polls is measured by using a Bayesian credible interval. For this study, the sample data is accurate to within ± 7.1 percentage points using a 95% confidence level. This credible interval will be wider among subsets of the surveyed population of interest. All sample surveys and polls, whether or not they use probability sampling, are subject to other multiple sources of error which are most often not possible to quantify or estimate, including, but not limited to coverage error, error associated with nonresponse, error associated with question wording and response options, and post-survey weighting and adjustments. To view survey details, including methodology, audience demographics, additional data from this survey and more, click here. Visit for more information. For the purposes of this survey, the term LGSOC refers to people diagnosed with low-grade serous carcinoma of the ovary or peritoneum (the thin layer of tissue lining the abdomen). About Low-Grade Serous Ovarian Cancer (LGSOC) LGSOC is a highly recurrent, chemotherapy-resistant cancer, associated with slow tumor growth and high mortality rate. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC is most often diagnosed in women between the ages of 45-55 and affects a younger patient population with bimodal peaks at ages 20-30 and 50-60 years of age, and has a median survival of approximately ten years. The majority of patients experience severe pain and complications as the disease progresses. While chemotherapy is the standard of care for this disease, there are no treatments specifically approved by the U.S. Food and Drug Administration to treat LGSOC and limited other treatment options are available. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and FAK inhibition. For more information, please visit and follow us on LinkedIn. View source version on businesswire.com: Contacts For Media Inquiries: Julissa Viana Vice President, Corporate Communications and Investor Relations media@verastem.com Source: Verastem Oncology View this news release online at:

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