In a remarkable convergence of clinical innovation and translational research, the Sylvester Comprehensive Cancer Center is poised to make a substantial impact at the upcoming ASCO 2025 meeting, the foremost annual conference of the American Society of Clinical Oncology. Scheduled to take place from May 30 to June 3 in Chicago, this event will showcase more than 60 presentations featuring Sylvester’s physician-scientists and researchers. Their investigative efforts span multiple oncology disciplines, highlighting cutting-edge therapeutic strategies, novel drug developments, and advances in supportive care for cancer patients.
Among the anticipated highlights is the randomized, multi-center ADVANCE clinical trial examining the efficacy of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without the addition of daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM). This trial aims to elucidate whether the incorporation of daratumumab can augment the anti-myeloma response and improve progression-free survival. Dr. C. Ola Landgren serves as first and presenting author, leveraging his extensive expertise in hematologic malignancies to advance therapeutic outcomes.
Another pioneering study involves a virtual reality (VR) intervention designed to ameliorate the distress experienced by patients undergoing hematopoietic stem cell transplantation (HSCT). This pilot randomized clinical trial, with Lara Traeger, Ph.D., as a co-author, investigates the psychosocial benefits of immersive VR environments to reduce anxiety and improve overall patient well-being during the rigors of transplantation. Such supportive care innovations underscore the growing emphasis on quality of life alongside traditional oncologic endpoints.
In the realm of chemotherapy-induced thrombocytopenia (CIT), a debilitating side effect that precipitates bleeding risks and treatment delays, a global, phase III randomized controlled trial examines the thrombopoietic agent romiplostim in colorectal, gastroesophageal, and pancreatic cancers. Co-authored by Dr. Gerald Soff, this large-scale study evaluates romiplostim’s capacity to restore platelet counts and maintain chemotherapy dose intensity, addressing a critical unmet need in managing CIT.
Targeted therapies are also prominently featured, including a combination cohort exploring casdatifan plus cabozantinib in clear cell renal cell carcinoma. This phase 1 ARC-20 expansion study is a testament to the evolving landscape of targeted kinase inhibitors and hypoxia-inducible factor (HIF) pathway modulation. Dr. Jaime Merchan’s involvement signals a robust effort to refine precision oncology approaches in a notoriously treatment-resistant cancer subtype.
For patients grappling with advanced uterine leiomyosarcoma post-chemotherapy, the Alliance A092104 randomized phase 2/3 trial compares olaparib plus temozolomide against investigator’s choice of therapy. Dr. Gina D’Amato co-authors this study, which interrogates the synergistic mechanisms of PARP inhibition alongside alkylating agents, potentially heralding new salvage regimens in a malignancy with historically dismal prognosis.
The innovative immunotherapeutic sphere is represented in a phase II randomized study evaluating neoadjuvant pembrolizumab, a PD-1 inhibitor, alone or in combination with vidutolimod, a toll-like receptor 9 (TLR9) agonist, for high-risk resectable melanoma. This ECOG-ACRIN EA6194 trial includes Dr. Jose Lutzky as a co-author, offering novel insights into the priming of innate immunity to potentiate checkpoint blockade efficacy. The designation as a late-breaking abstract underscores its anticipated clinical significance.
Digital health technologies are gaining traction as adjuncts in cancer care delivery, exemplified by a randomized controlled trial assessing a psychosocial digital application for caregivers of HSCT patients. Co-authored by Dr. Lara Traeger, this intervention targets caregiver burden and mental health, integrating behavioral science with oncology support services to improve the caregiver-patient dyad’s resilience.
Further advancing cellular immunotherapy, a phase 1 clinical update details the administration of IMA203, an autologous T cell receptor-engineered T cell (TCR-T) product targeting PRAME, in PD-1 refractory metastatic melanoma patients. Dr. Leonel Hernandez-Aya’s co-authorship highlights progress in adoptive cell therapies addressing the immunoresistant tumor microenvironment, potentially heralding durable remissions in refractory melanoma.
In leiomyosarcoma, Dr. Jonathan Trent contributes to a randomized phase III trial investigating catequentinib hydrochloride (AL3818), a multi-targeted receptor tyrosine kinase inhibitor, versus placebo. This study aims to delineate the drug’s efficacy in metastatic or advanced disease, potentially expanding the therapeutic armamentarium for this aggressive sarcoma subtype.
Addressing public health implications, a presentation on the escalating impact of alcohol-related cancer mortality in the United States, led by Dr. Chinmay Jani with senior authorship by Dr. Gilberto Lopes, issues a clarion call for intensified preventive measures. Their analysis sheds light on epidemiological trends, urging a multidisciplinary response to mitigate alcohol’s oncogenic burden.
The complex interface of tumor epigenetics and immune resistance forms another research focal point, detailed in the NIBIT-ML1 phase II study of nivolumab plus ipilimumab combined with ASTX727 or nivolumab plus ipilimumab alone for PD-1 resistant metastatic melanoma. With Dr. Michele Ceccarelli’s participation, the clinical correlation of tumor methylation landscapes offers profound implications for overcoming checkpoint inhibitor resistance through epigenetic modulation.
Translational diagnostics receive attention through evaluating the clinical utility of a combined circulating tumor DNA (ctDNA) and circulating tumor RNA (ctRNA) next-generation sequencing (NGS) liquid biopsy assay. Co-authored by Dr. Gilberto Lopes, this study explores enhanced sensitivity and specificity in liquid biopsy platforms, aiming to revolutionize real-time tumor genomic profiling and therapeutic monitoring across cancer types.
Lastly, the IMPROVE study, a phase 1/1B trial of imetelstat (a telomerase inhibitor) plus ruxolitinib (a JAK1/2 inhibitor) in patients with intermediate-1, intermediate-2, or high-risk myelofibrosis, features Dr. Terrence Bradley as a co-author. This investigation into combinatorial targeted therapies as a strategy to modify disease progression represents a critical step toward personalized myeloproliferative neoplasm treatment.
Beyond the conference, Sylvester researchers are also preparing to commence a landmark clinical trial evaluating EP31670, a novel, first-in-class epigenetic-cancer therapeutic. Developed over 14 years in the laboratory of Dr. Claes Wahlestedt, this agent embodies a translational triumph transitioning from bench to bedside. The upcoming trial, led at Sylvester by principal investigator Dr. Terrence Bradley and co-investigator Dr. Justin Watts, targets chronic leukemias, offering hope for patients with limited therapeutic options.
Concurrently, recent epidemiological data from the American Cancer Society reveal a complex cancer landscape. While overall cancer mortality rates have declined substantially over the past three decades, certain demographic shifts raise concerns. Notably, lung cancer incidence is rising alarmingly among women, with diagnoses increasing by 84% since 1983, and younger women increasingly presenting with this disease. Dr. Estelamari Rodriguez, clinical research lead at Sylvester’s Thoracic Site Disease Group, emphasizes this unsettling trend, which challenges existing assumptions about risk stratification and preventive strategies.
Amid these clinical and epidemiological efforts, basic science research continues to unravel the molecular underpinnings of cancer resistance. For example, the work of Dr. Lluis Morey delves into epigenetic remodeling mechanisms that enable tumor cells to evade therapeutic assaults. By elucidating these pathways, he lays the groundwork for innovative drugs designed to circumvent resistance and sustain treatment efficacy in malignancies such as breast cancer. This foundational knowledge is imperative for the next generation of tailored oncology treatments.
Altogether, the multiplicity of programs originating from Sylvester Comprehensive Cancer Center, spanning from preclinical models to large-scale clinical trials and epidemiological investigations, exemplify a holistic approach to conquering cancer. The integration of advanced molecular science, immunotherapy, supportive care innovations, and digital health signals an era of unprecedented opportunity. As the scientific community gathers at ASCO 2025 and beyond, these endeavors stand to redefine the boundaries of cancer treatment and patient care on a global scale.
Subject of Research: Advances in oncology including clinical trials of novel therapeutics, supportive care innovations, and cancer epidemiology.
Article Title: Sylvester Comprehensive Cancer Center’s Pivotal Contributions to ASCO 2025: Advancing Oncology Science and Care
News Publication Date: May 2025
Web References:
https://umiamihealth.org/en/sylvester-comprehensive-cancer-center
https://www.asco.org/annual-meeting
https://news.med.miami.edu/novel-first-in-class-cancer-drug-in-clinical-trials-at-sylvester/
https://news.med.miami.edu/american-cancer-society-notes-cancer-trends-toward-younger-people/
https://news.med.miami.edu/cancer-epigenetics-researcher-searches-for-head-and-neck-cancer-treatments/
Image Credits: Photo by Sylvester Cancer Center
Keywords: Cancer, Clinical Trials, Immunotherapy, Epigenetics, Multiple Myeloma, Melanoma, Lung Cancer, Liquid Biopsy, Hematopoietic Stem Cell Transplantation, Myelofibrosis, Targeted Therapy, Digital Health