Endometrioid Carcinoma

PRESS RELEASE 18/03/2025, 07:00 CET Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting Mechelen, Belgium, 18 March 2025 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce research on the Idylla™ Platform from several renowned institutions at the upcoming United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting, taking place from 22-27 March in Boston, MA, US. Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla™ Platform across several different cancer types, including lung cancer1, thyroid cancer2, endometrial carcinoma3 and colorectal cancer4. Biocartis also continues to focus on melanoma, blood, brain and breast cancer. 1. From Discard to Discovery: Rapid KRAS and EGFR Mutation Detection in Lung Cancer Using Cytology Supernatants Institution: MD Anderson Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 20 Researchers evaluated the use of the Idylla™ ctKRAS and ctEGFR Mutation Assays on cytology supernatants from lung cancer patients. The study demonstrated high concordance with next-generation sequencing (NGS) results, reinforcing the Idylla™ assays as valuable tools for rapid testing of cytology supernatants that would otherwise be discarded. 2. Racing for Results: Ultra-Rapid BRAF Mutation Detection Through Fine Needle Aspiration (FNA) of Anaplastic Thyroid Carcinoma (ACT) and High-Grade Follicular Cell-Derived Thyroid Carcinoma (HGFCTC) Institution: Memorial Sloan Kettering Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 31 This study compared the turnaround time and performance of the Idylla™ BRAF Mutation Assay with immunohistochemistry (IHC) and NGS in aggressive thyroid malignancies. The results demonstrated that Idylla™ can provide a significantly faster and reliable assessment of BRAF status in fine needle aspiration samples. 3. Detailed Analysis of MSIsensor2 Signatures in Endometrial Endometrioid Carcinomas with Next Generation Sequencing Institution: University of California, San Francisco.To be presented: Monday 24 March, Stowell-Orbison – Informatics - Poster Board 306 This study utilized MSIsensor2 within an NGS pipeline to assess MSI status across 100 cases of endometrial endometrioid carcinoma (EEC). The research analyzed tumor purity, the impact of mismatch repair (MMR) driver gene mutations, and the correlation of MSI scores with molecular and clinicopathologic data. Orthogonal MSI testing was performed by fragment analysis or Idylla™. 4. Comparison of Two Automated Real-Time PCR Systems for Cytological Smears in NSCLC: IDYLLA™ and AmoyDx® Pan Lung Cancer Panel Institution: Clinica Universidad de Navarra.To be presented: Monday 24 March, Poster II – Cytopathology - Poster Board 44 This study compared the Idylla™ System with the AmoyDx® Pan Lung Cancer Panel for molecular testing on cytological smears in non-small cell lung cancer (NSCLC). Both systems showed high concordance with each other and with NGS results, when available. The Idylla™ System detected additional KRAS mutations not included in the AmoyDx® Panel, underscoring its broader detection capabilities. While NGS remained the gold standard, these automated systems offered faster turnaround times for targeted treatment decisions. 5. Evaluation of Microsatellite Instability Testing by the Rapid Idylla™ MSI Assay in Endometrial and Other CancersInstitution: Icahn School of Medicine at Mount Sinai.To be presented: Tuesday 25 March, Poster IV - General Surgical Pathology This study evaluated the performance of the Idylla™ MSI Assay in endometrial and other cancers, revealing strong sensitivity and specificity in colorectal cancer and highlighting variability in endometrial carcinoma (EC). Adjustments in threshold settings demonstrated improved concordance metrics in EC. 6. Assessment of (Rare) Endometrial Carcinoma with Double Molecular Classifiers Using Limited Panel Next Generation Sequencing (NGS): Evaluation of Surrogate Metrics for Tumor Mutation Burden (TMB) – A Proof of Concept StudyInstitution: Mayo Clinic.To be presented: Wednesday 26 March, Poster V - Gynecologic and Obstetric Pathology This study assessed a limited NGS panel and its ability to classify rare double-molecular-classifier cases in endometrial carcinoma. It incorporated Idylla™ as an orthogonal CLIA-validated MSI testing method, showcasing its role in resolving discrepancies in molecular classification. 7. Routine Implementation of the Idylla™ Fusion Assay: An Assessment of Performance Based on Prospective Reflex Testing of Non-Small Cell Lung Carcinoma in a Large Laboratory Setting Institution: Memorial Sloan Kettering Cancer Center.To be presented: Wednesday 26 March, Poster V - Pulmonary, Mediastinal, Pleural, and Peritoneal Pathology This study evaluated the routine use of the Idylla™ GeneFusion Assay for detecting fusions in ALK, ROS1, RET, and NTRK1/2/3, as well as MET exon 14 skipping in NSCLC. The Assay demonstrated high sensitivity and specificity, with a fast turnaround time compared to traditional testing methods. In addition, Biocartis will showcase the Idylla™ Platform and its innovations in molecular diagnostics at booth #548, where attendees can learn more about Idylla™’s ability to deliver actionable, molecular biomarker results in only 3 hours. W. Michael Korn, M.D., Chief Medical and Scientific Officer of Biocartis, commented: “The data presented at USCAP 2025 underscores the versatility and reliability of the Idylla™ Platform across a diverse range of oncology applications. These studies confirm the high concordance between Idylla™ and next-generation sequencing (NGS) in lung cancer, and Idylla™’s ability to detect microsatellite instability (MSI) reliably, demonstrating its clear value in delivering rapid, actionable molecular insights. The integration of Idylla™ into real-world laboratory settings, as highlighted in these independent investigator studies, reinforces its potential to streamline workflows and reduce turnaround times, ultimately improving patient management and outcomes.” ----- END ----- More information: www.biocartis.com info@biocartis.com Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, easy, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. ​Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain and blood cancer. More information: www.biocartis.com. Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers The data and conclusions provided in this external publication were derived externally by third parties and have not been validated in the development of the Idylla™ Assays or included in the products' current labelling by Biocartis NV. Biocartis NV products are designed to be used as described in the product-specific instructions. Idylla™ ctKRAS, ctEGFR & BRAF Mutation Assays and Idylla™ GeneFusion & MSI Assays are for Research Use Only (RUO), not for use in diagnostic procedures. Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © March 2025, Biocartis NV. All rights reserved. 1 Lung cancer remains one of the leading causes of cancer-related mortality, strongly linked to smoking and environmental exposures. Advances in biomarker testing have revolutionized treatment by enabling personalized approaches such as targeted therapies and immunotherapy. Depending on the stage of the disease, treatment may involve a combination of surgery, chemotherapy, radiation, or precision medicine.2 Thyroid Cancer develops in the thyroid gland, often detected as a painless lump in the neck. Prognosis is generally favorable, especially when caught early. Biomarker testing helps assess risk and guide treatment. Standard therapies include surgery, radioactive iodine, and thyroid hormone replacement. 3 Endometrial Cancer is a malignancy of the uterine lining, that most commonly affects postmenopausal women. Biomarker testing plays a crucial role in assessing prognosis and guiding treatment decisions. Management typically involves surgery, with additional therapies such as radiation or hormone treatment considered based on individual risk factors and molecular profiling.4 Colorectal Cancer is affecting the colon or rectum, often linked to lifestyle and genetic factors. Biomarker testing helps guide treatment decisions, particularly in targeted therapy and immunotherapy. Testing for these markers can identify patients who may benefit from specific therapies, such as anti-EGFR or immune checkpoint inhibitors.

THURSDAY, Feb. 20, 2025 -- Short-course vaginal cuff brachytherapy (VCB) is noninferior to standard regimens for short-term quality of life in people with early-stage endometrial cancer , according to a study published online Dec. 4 in JCO Oncology Advances . Gita Suneja, M.D., from the Huntsman Cancer Institute at University of Utah in Salt Lake City, and colleagues examined short-course adjuvant VCB (11 Gy × two fractions at the surface) versus standard regimens (7 Gy × three fractions at 0.5 cm depth; 6 Gy × five fractions at the vaginal surface; or 5 to 5.5 Gy × four fractions at 0.5 cm depth). The analysis included 108 patients (54 in each arm) who underwent hysterectomy and had pathologically confirmed endometrioid adenocarcinoma, serous sarcoma, clear cell sarcoma, or carcinosarcoma (stage I or II). The researchers found that Global Health Status, as measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core Module, with two fractions was noninferior to standard of care at one and 12 months. Using the EORTC Quality of Life Questionnaire-Endometrial Cancer Module, the change in mean patient-reported symptom score for patient-reported vaginal/sexual, urologic, and gastrointestinal symptoms from baseline to one and 12 months was not significantly different between arms. Short-term adverse events were reported in 37 percent of patients in the experimental arm and 57 percent of patients in the control arm. The vaginal control rate was 96 percent in both arms at 28-month median follow-up. "This approach, while maintaining short-term local control, holds promise in enhancing resource utilization, expanding access to care, and improving the overall treatment experience for individuals with endometrial cancer necessitating adjuvant VCB," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

nab-Sirolimus demonstrated significantly greater intratumoral drug concentration, stronger inhibition of mTOR targets and greater antitumor activity compared to IV and oral mTOR inhibitors in a xenograft model Data support further clinical exploration of nab-sirolimus as a single agent or in combination LOS ANGELES, May 23, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced new nonclinical data demonstrating the significantly higher intratumoral drug concentration, stronger inhibition of mTOR targets and greater antitumor activity of nab-sirolimus compared to intravenous and oral mTOR inhibitors in a xenograft model. These data will be available as an abstract and published in the Journal of Clinical Oncology supplement to coincide with the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, 2024. "Our goal at Aadi is to unlock the full power of mTOR inhibition by combining nanoparticle albumin bound (nab) technology with sirolimus to improve delivery, stability, solubility and targeting," said Loretta Itri, MD, Chief Medical Officer at Aadi. "With superior findings across key markers, these important nonclinical data add to our growing body of evidence that nab-sirolimus may overcome limitations of previous therapies, including both orally and intravenously delivered mTOR inhibitors, with the potential to play an important therapeutic role in difficult-to-treat cancers." Abstract details and highlights include: Title: Antitumor activity of nab-sirolimus versus mTOR inhibitors temsirolimus, sirolimus, and everolimus in A549 NSCLC xenografts Lead Author: Shihe Hou Abstract: Despite the broad importance of the mTORC1 pathway in cancer cell growth and survival, mTOR inhibitors (mTORis) temsirolimus, sirolimus and everolimus have limited clinical application in the cancer setting. In A549 xenografts, nab-sirolimus resulted in significantly greater suppression of tumor growth compared with IV temsirolimus and oral sirolimus and everolimus. Average intratumoral drug concentrations 24 hours after IV mTORi treatment were significantly higher with nab-sirolimus (420-539 ng/g) compared with temsirolimus (34.9 ng/g) and its active metabolite (13.2 ng/g); similarly, tumor uptake of nab-sirolimus greatly exceeded that of sirolimus and everolimus at steady-state. We believe these results support further clinical evaluation of nab-sirolimus as a single agent or in combination with other therapeutic agents. In addition, Aadi will present a trials-in-progress poster on its Phase 2 trial in advanced or recurrent endometrioid-type endometrial cancer (EEC), a difficult-to-treat mTOR-driven cancer. Endometrial cancer is the most common cancer of the female reproductive organs and one of the few cancers with increasing mortality. There are an estimated 10,000 cases of EEC diagnosed annually. Poster details and abstract highlights include: Title: A phase 2, open-label, single-arm, prospective, multicenter study of nab-sirolimus plus letrozole in advanced or recurrent endometrioid endometrial cancer Presenting Author: Lauren Dockery, MD, MS Session Title: Poster Session – Gynecologic Cancer Abstract Number: TPS5640 Date/Time: Monday, June 3rd, 9:00 am – 12:00 pm This is a Phase 2 open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus and letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma, exploring the potential for this combination to produce additive anti-tumor activity in patients with EEC. Dysregulation of mTOR signaling is implicated in the pathology of EEC, in which >80% harbor PTEN or PI3K/AKT/mTOR pathway alterations. Prior clinical studies with mTOR inhibitors and letrozole in endometrial cancer patients have yielded promising results. Alternative treatment options for patients with advanced or recurrent EEC remain necessary despite recent pivotal data demonstrating improved outcomes with immunotherapy plus chemotherapy. About Aadi Bioscience Aadi is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway, a key regulator of cell growth and cancer progression. To unlock the full potential of mTOR inhibition, Aadi uniquely combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus. Aadi received FDA approval and commercializes FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Aadi is exploring nab-sirolimus in PRECISION1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi is also exploring nab-sirolimus in two single-indication Phase 2 trials for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors (NETs), and advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole. More information on Aadi's development pipeline is available on the Aadi website at and connect with us on Twitter and LinkedIn. Forward-Looking Statements This press release contains certain forward-looking statements regarding the business of Aadi that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on Aadi's current beliefs and expectations and may include, but are not limited to, statements relating to: expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of nab-sirolimus; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to nab-sirolimus, including in EEC; and the sufficiency of Aadi's existing capital resources and the expected timeframe to fund Aadi's future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, those associated with the uncertainties associated with the clinical development and regulatory approval of nab-sirolimus in additional indications; the risk that non-clinical results may not be reproduced and do not necessarily predict clinical results; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing nab-sirolimus; and risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in Aadi's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including under the caption "Item 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at . All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: [email protected] SOURCE Aadi Bioscience