Thymoma

MEDSIR together with Oncoclinicas & Co., leads independent clinical research at the largest European congress of medical oncology, with the presentation of 12 studies, marking a new scientific milestone for the company. The ABIGAIL study stands out for its innovative strategy, evaluating the combination of abemaciclib with endocrine therapy as an alternative treatment without chemotherapy in first-line HR+/HER2- advanced breast cancer with poor prognosis criteria. The PECATI study, focused on patients with advanced thymic tumors, a rare type of cancer, has demonstrated an 88% rate of progression-freedisease in the first 5 months. The company hosted MEDTalks, a satellite symposium dedicated to advancing brain metastasis research, addressing a critical unmet need in solid tumors such as lung, breast, and skin cancers. BARCELONA, Sept. 16, 2024 /PRNewswire/ -- MEDSIR, a leading company dedicated to promoting independent clinical research in oncology internationally and part of Oncoclinicas & Co, the largest hospital group dedicated to cancer treatment in Latin America, participated this year in the congress of the European Society for Medical Oncology (ESMO), held in Barcelona, presenting 12 new studies addressing different types of cancer. Continue Reading Dr. Juan de la Haba presenting ABIGAIL study at ESMO The studies presented by MEDSIR reflect its pivotal approach and commitment to innovation in personalized treatments, highlighting advances in prostate (ZZFIRST study), breast (ABIGAIL), thymic (PECATI) and lung (I3Lung.) cancers. Among these, the I3Lung study, funded by the European Union, integrates artificial intelligence models to optimize individualized treatments, reaffirming MEDSIR's commitment to cutting-edge research. These studies underscore the strong commitment to significantly expand therapeutic options for patients facing complex and difficult-to-treat cancers. Among the most relevant studies is ABIGAIL, in patients with HR+/HER2- advanced breast cancer and poor prognosis criteria. Its objective is to provide consistent evidence that the treatment strategy with abemaciclib (a CDK4/6 inhibitor) in combination with endocrine therapy as first-line treatment in advanced breast cancer is not inferior to paclitaxel (the standard chemotherapy commonly used in this type of patient) in terms of overall response rate and safety during the first 12 weeks. The aim of this study is to provide hope to patients by offering a chemotherapy-free treatment option. The overall response rate at 12 weeks was markedly better in the group treated with the combination of abemaciclib and endocrine therapy (59%) compared to the group receiving chemotherapy (40%). "The data from the ABIGAIL study are a crucial step forward for patients with HR+/HER2- advanced breast cancer. The possibility of offering a chemotherapy-free alternative not only improves quality of life, but also offers new perspectives for these patients with poor prognostic criteria. This study reinforces our commitment to finding more effective and less aggressive therapeutic solutions for those who need it most," adds Dr. Juan de la Haba, principal investigator of the study and oncologist at the Reina Sofia University Hospital in Córdoba (Spain). Another highlight of the congress was the oral presentation of the PECATI study, aimed at patients with thymic tumors, a rare disease that includes thymomas and thymic carcinomas. To date, there have been no standard treatments for metastatic thymic carcinomas beyond chemotherapy, and therapeutic advances in this field have been scarce due to the low prevalence of the disease. The study, an international initiative conducted in 10 hospitals in Spain, Italy and France, evaluated the efficacy of combining two drugs, lenvatinib and pembrolizumab (immunotherapy treatment), in patients with advanced and previously treated thymic tumors. The results were positive, as 88% of the patients had no disease progression during the first 5 months of treatment, and in more than half of the patients (62%) the disease had not progressed at 12 months after the start of treatment. These findings highlight the potential efficacy of this combination therapy and could be considered a future gold standard treatment for this pathology. "These results are truly promising. Thanks to research, we are opening up new therapeutic possibilities that make a difference in patients' lives. While research is essential to improve treatments in any type of cancer, it becomes even more relevant in rare tumors such as thymomas, where treatment options are more limited," says Dr. Jordi Remon, principal investigator of the study and medical oncologist at the Institut Gustave Roussy in Paris, France. These positive results not only reflect a significant advance in the treatment of patients with limited therapeutic options, but also consolidate the importance of innovation and the integration of new treatments in the optimization of therapeutic regimens. MEDSIR is thus positioned at the forefront of oncology research, pushing the frontier of scientific knowledge towards new therapeutic possibilities. Advancing research in the area of brain metastases In addition, the company led a symposium on brain metastasis (September 14th), which addressed the essential role of Investigator-Initiated Trials (IITs) and pharmaceutical industry-sponsored trials in revolutionizing our understanding and treatment strategies for one of the biggest challenges, brain metastasis. This remains a critical unmet need, particularly in solid tumors such as lung, breast, and skin cancers. As a tough challenge in oncology, brain metastasis requires innovative solutions and collaborative efforts. The event, named MEDTalks, featured chairs like Prof. Antonio Llombart, MEDSIR Senior Scientific Lead, and Prof. Mathias Preusser, Head of the Clinical Division of Oncology at the Medical University of Vienna. During a 360° overview of the biology, pathology, and development of brain metastases, along with recent advancements in systemic management, speakers focused on groundbreaking new drugs, such as Antibody-Drug Conjugates (ADCs) and radio-ligands, delving into the emerging field and potential of theranostics in oncology. About MEDSIR Established in 2012, MEDSIR is distinguished by its close collaboration with strategic partners to drive innovation in oncology research. Based in Spain and the United States, the company provides end-to-end management of clinical trials, spanning from study design to subsequent publication, relying on an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials. With the aim of promoting independent research globally, MEDSIR has established a strategic alliance with Oncoclinicas, the leading oncology group in Brazil with outstanding research potential in South America. For more information: About Oncoclinicas & Co. Oncoclínicas&Co. is the largest group dedicated to cancer treatment in Latin America, with a specialized and innovative model focused on the entire oncology care journey, combining operational efficiency, humanized care and specialization through a medical team composed of more than 2,700 medical specialists with emphasis in oncology. With the mission of democratizing oncology treatment, it offers a comprehensive system that integrates outpatient clinics with highly complex oncology centers. The company operates 145 units in 39 Brazilian cities, allowing high quality access in all regions where it operates, aligned with world reference standards. With a focus on technology, precision medicine and genomics, Oncoclinicas performed approximately 635,000 treatments in 2023. It is the exclusive partner in Brazil of the Dana-Farber Cancer Institute, affiliated with Harvard Medical School, one of the world's leading cancer research and treatment centers. The company also owns Boston Lighthouse Innovation, a bioinformatics company based in Cambridge, USA, and has a stake in MedSir, a company dedicated to the development and management of clinical trials for independent cancer research, based in Barcelona, Spain. Recently, Oncoclinicas expanded its operations to Saudi Arabia through a joint venture with the Al Faisaliah Group, bringing its mission of defeating cancer to a new continent and providing advanced cancer care on a global scale by combining oncology hyperspecialization with innovative treatment approaches. The company is part of the IDIVERSA index, launched by B3, which highlights companies committed to gender and racial diversity. For more information, visit: SOURCE MEDSIR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Before the start of the ESMO congress, MEDSIR has brought together scientists, researchers, pharmaceutical companies, and patient association representatives to analyse the key points that will drive innovation in breast and lung cancer research and treatment over the next decade. BARCELONA, Spain, Sept. 13, 2024 /PRNewswire/ -- In the framework of the European Society of Medical Oncology (ESMO) congress, held in Barcelona from September 13th to 17th, MEDSIR, a company that is part of Oncoclínicas & Co, dedicated to promoting independent clinical research in oncology internationally, hosted an informational breakfast with key players in cancer research to discuss the present and future of breast and lung cancer treatments. The discussion focused on crucial aspects and challenges for future research, including optimizing the recruitment process, the importance of early detection, access to the most innovative treatments, the promotion of disruptive, collaborative, and international research, and the incorporation of innovative technologies such as Artificial Intelligence. Continue Reading Dr. Antonio Llombart-Cussac speaking during the informational breakfast The event discussed the most recent advances in oncology research and treatment on both national and international levels, with a particular focus on rare cancers with limited therapeutic options. 'One of the main challenges we will face in the next 10 years is finding ways to integrate treatment innovations with advances in new technologies to offer new hope to patients. Besides new technologies, both proper prevention and early detection remain fundamental tools to stay ahead of the disease,' says Dr. Antonio Llombart-Cussac, MD, PhD, Senior Scientific Leader at MEDSIR and Head of the Medical Oncology Department at Arnau de Vilanova Hospital. The importance of international collaboration in research was emphasized by Dr. Carlos Gil Ferreira, Medical Director of Oncoclínicas & Co, the largest oncology treatment group in Latin America. He highlighted the collaboration with MEDSIR to "promote clinical research worldwide thanks to the expertise of our doctors and MEDSIR's ability to design clinical trials. The synergy between our teams has been fundamental in expanding access to innovative solutions and developing clinical studies that truly impact patient care". From the pharmaceutical industry perspective, Maria José Martínez, Medical Head of Solid Tumors at Novartis, stated: "For us, innovation lies in integrating the voices of patients, researchers, and the healthcare system itself into the development of new treatments, adapting to their reality, and ultimately addressing the major challenges in managing the disease". From the patient's perspective, the discussion explored unmet needs and the importance of reaching all patients, regardless of the complexity of their condition, to ensure their longevity and quality of life. Pilar Fernández Pascual, President of the Spanish Metastatic Breast Cancer Association, echoed this sentiment, saying, "Patients are in a hurry to live, and that means increasing resources for research, facilitating access to clinical trials, raising awareness of the disease, and shortening the time for approval of innovative drug funding to improve their quality of life". Alfonso Aguarón, spokesperson for Lung Cancer Europe (LuCE), added, "Artificial Intelligence provides the opportunity to develop more precise treatments thanks to its vast capacity for global data analysis, ensuring that patients live longer and better." Workshop on Artificial Intelligence in Cancer Research The application of Artificial Intelligence (AI) in research was another key topic of the session. The use of innovative technology is crucial in addressing current research challenges, such as the potential to develop personalized treatments for patients. It also serves as a tool not only to assist oncologists but also to provide more information to patients themselves. This was demonstrated by Arsela Prelaj, Medical Oncologist at the Istituto Nazionale dei Tumori in Milan, who presented the European I3LUNG project, which seeks to improve the treatment of patients with non-small cell lung cancer (NSCLC), a particularly aggressive form of lung cancer, through AI. "Technology has undoubtedly become a key ally for a comprehensive approach to the disease, facilitating collaboration between Artificial Intelligence and oncologists to achieve increasingly precise and early diagnoses." Attendees also participated in a practical session on how to apply AI in the interpretation of scientific studies. In addition to Dr. Prelaj, Gustavo Entrala, Senior Advisor at LLYC and expert in digital transformation, stated, "For the first time in history, we have technology that understands us and can help us in decision-making. These tools are increasingly of higher quality and reliability, allowing for the optimization of processes and resources in healthcare, such as detecting patterns in pathologies, clinical diagnosis, or the design and optimization of clinical trials." Quality scientific research: among the European Union's priorities Recently, Ursula Von der Leyen, President of the European Commission, presented her political guidelines for the next term (2024-2029) under the title "The Choice of Europe". The document outlines an agenda to address the multiple challenges facing the European Union, including the Biotechnology Law. Similar conclusions were drawn from the report "The Future of European Competitiveness"1, presented by Mario Draghi, former President of the European Central Bank (ECB), which highlights the need to increase investment in research and innovation and the potential role of AI in improving this research. This strategy is fully aligned with the goals and trajectory of MEDSIR, which has experienced exponential growth in just 13 years, with a vast network of more than 500 independent researchers worldwide and several trials with significant results for the treatment of various types of cancer, such as the recently published PHERGain study in the prestigious journal The Lancet. An increase in research investment is expected, focusing on strategic priorities, innovative fundamental research, and disruptive advancements.2 Cancer data Cancer remains one of the leading causes of morbidity and mortality worldwide and in Spain, where approximately 181 million new cases were diagnosed globally in 2020, with projections expected to reach 28 million annually by 2040. In Spain, REDECAN predicts 286,664 cases in 2024. This increase in Spain is due to population growth, aging, and risk factors such as tobacco, alcohol, obesity, and sedentary lifestyles. Among the most prevalent tumours, breast cancer is the most diagnosed globally since 2021, with 36,395 new cases expected in Spain by 2024, and lung cancer remains the leading cause of cancer death, with 18 million deaths in 2020. MEDSIR has been part of this study alongside other European partners. Moreover, at the ESMO congress, it will present 12 new studies focused on patients with limited therapeutic options, in collaboration with its partner Oncoclínicas & Co. Among the most notable are PECATI, focused on patients with thymic tumors (including thymomas and thymic carcinomas); ABIGAIL, aimed at patients with advanced HR+/HER2- breast cancer with poor prognosis characteristics; and ZZ-FIRST, for patients with metastatic hormone-sensitive prostate cancer who are not candidates for curative treatments. About MEDSIR Founded in 2012, MEDSIR stands out for its close collaboration with strategic partners to drive innovation in cancer research. With headquarters in Spain and the United States, the company manages clinical trials from study design to publication, with a vast global network of experts and integrated technology to streamline the process. The company provides support for proof-of-concept trials and a strategic approach that allows research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials. In pursuit of promoting independent global research, MEDSIR has established a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, with notable research potential in South America. For more information: About Oncoclínicas & Co. Oncoclínicas & Co. is the largest group dedicated to cancer treatment in Latin America, with a specialized and innovative model focused on the entire oncology care journey, combining operational efficiency, humanized care, and specialization through a medical team of more than 2,700 specialists with a focus on oncology. With a mission to democratize cancer treatment, it offers an integrated system that combines outpatient clinics with high-complexity oncology centres. The company operates 145 units in 39 Brazilian cities, providing high-quality access in all regions where it operates, aligned with global reference standards. With a focus on technology, precision medicine, and genomics, Oncoclínicas conducted approximately 635,000 treatments in 2023. It is the exclusive partner in Brazil of the Dana-Farber Cancer Institute, affiliated with Harvard Medical School, one of the leading cancer research and treatment centres in the world. The company also owns Boston Lighthouse Innovation, a bioinformatics company based in Cambridge, USA, and has a stake in MEDSIR, a company dedicated to the development and management of clinical trials for independent cancer research based in Barcelona, Spain. Recently, Oncoclínicas expanded its operations to Saudi Arabia through a joint venture with the Al Faisaliah Group, bringing its mission to conquer cancer to a new continent and providing advanced oncology care on a global scale by combining oncology hyper-specialization with innovative treatment approaches. The company is part of the IDIVERSA index launched by B3, which highlights companies committed to gender and racial diversity. For more information, visit: . 1 Comisión Europea. The future of European competitiveness: Report by Mario Draghi 2 ConSalud. Así es la nueva Ley de Biotecnología de la UE aplaudida por el sector farmacéutico. Link SOURCE MEDSIR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cartesian Therapeutics shared plans to raise $130 million. Cartesian Therapeutics has claimed a phase 2b win for its BCMA-directed CAR-T therapy in generalized myasthenia gravis (gMG). But the biotech’s victory came on a primary endpoint it changed in May and in a population that excluded the 25% of participants treated at community clinics. Investigators randomized 36 patients to receive Descartes-08 or placebo. Cartesian restricted its primary endpoint analysis to 26 people enrolled at academic medical centers who received at least one dose and completed at least one post-baseline assessment of MG Composite (MGC) score. The decision removed nine patients treated at community clinics from the primary analysis. Another subject dropped out. The biotech switched its primary endpoint from the MG-ADL symptom scale to MGC in May. Argnex, Johnson & Johnson and UCB looked at MG-ADL for the primary endpoints of their pivotal gMG studies.  In Cartesian’s primary efficacy population, 10 out of the 14 recipients of Descartes-08 had a five-point or greater improvement in MGC after three months. Three of the 12 participants on placebo had such an improvement. The difference in response rates, 71% versus 25%, was enough for the clinical trial to meet the MGC endpoint in the modified intent-to-treat efficacy population. The biotech said a three-point change in MGC is generally seen as clinically meaningful. Cartesian used the “more stringent endpoint of five points” based on the responses seen in an earlier study. The press release lacks details of how Descartes-08 compared to placebo using a three-point response threshold.  Cartesian did share results from a per-protocol population that included 31 patients. In that population, the MGC response rates in the Descartes-08 and placebo arms were 69% and 33%, respectively, resulting in a p-value of 0.048. The biotech assessed change from baseline in MG-ADL, the original primary objective, as a secondary endpoint. Recipients of Descartes-08 had a mean 5.6-point improvement on the MG-ADL symptom scale after three months. MG-ADL scores in the placebo arm kept pace with the treatment cohort over the first month but then reversed. The placebo improvement was less than two points after three months.  Cartesian reported a significant imbalance in the proportion of people with thymoma, a type of cancer associated with gMG. While 42% of people on placebo had thymoma, none of their counterparts in the Descartes-08 arm had the cancer. There were numeric imbalances on other variables, with more people on placebo having received complement inhibitors or FcRN drugs and had their thymus removed.  The readout is the first big milestone for Cartesian since it joined the Nasdaq through a reverse merger with Selecta Biosciences. Cartesian emerged from the deal with $110 million to test its belief that mRNA can make CAR-T viable in autoimmune disorders by reducing the toxicity associated with DNA cell therapies and by eliminating the need for preconditioning chemotherapy. Cartesian ended March with almost $105 million, a sum it said would support operations into the second half of 2026. The biotech shared plans to raise $130 million through a private investment in public equity alongside news of the phase 2b results.