Titles and Affiliations
Professor, Department of Oncology
Director and Professor Gerald O’Sullivan Chair, Cancer Research
Adjunct Associate Professor of Medical Oncology, Johns Hopkins University
Research area
Investigating new and innovative biomarkers to support more individualized treatment plans for triple-negative breast cancer patients.
Impact
Proteins known as “immune checkpoints” are key players in preventing the immune system from attacking cells indiscriminately. Some cancers can evade an immune response by simulating these proteins which, in turn, decreases anti-tumor immunity. Immunotherapy agents can block these immune checkpoint proteins and demonstrate impressive tumor shrinkage and long-term survival in some patients with select cancers such as advanced triple-negative breast cancer (TNBC). More recent clinical trials have demonstrated the value of adding an immune checkpoint inhibitor pembrolizumab to chemotherapy in early-stage TNBC and led to the FDA approval of this combination as standard of care for these patients. Dr. Connolly is focused on identifying biomarkers related to the tissue environment surrounding tumors (immune biomarkers) and the breast cancer “microbiome”, or the bacterial composition of breast cancers. This approach may help determine which patients would benefit from this combination treatment, ensuring a more personalized approach for treatment, minimizing treatment-related side effects while maintaining efficacy.
Progress Thus Far
Dr. Connolly and her team have nearly completed their analysis of biobanked breast cancer samples for immune and microbial evaluation, which has yield important insights into the challenges around identification of bacterial signatures in stored breast tumor tissue. The team is actively recruiting participants to a prospective neoadjuvant clinical trial, Microbiome Immunotherapy Neoadjuvant Assessment (MINA), which will build on these results. Dr. Connolly’s overarching goal is to ensure that patients with TNBC have a personalized approach to breast cancer treatment, tailoring the right treatment for the right patient.
What’s Next
Dr. Connolly and her colleagues will build on their progress and complete analyses of patient samples to understand how the immune system and microbiome respond to treatment in TNBC. The team is continuing to recruit participants to the MINA study. Dr. Connolly is also developing a new clinical trial for advanced breast cancer that will evaluate microbial and genomic parameters, designed in partnership with scientists and patient advocates. This trial will open in late 2025 and begin collecting samples in 2026, helping generate new insights that can guide future treatment strategies.
Biography
Roisin Connolly, MD is the Professor Gerald O’Sullivan Chair in Cancer Research at University of College Cork (UCC) and Cork University Hospital (CUH). She is also the Director of Cancer Research at UCC, a Principal Investigator with Cancer Trials Cork at CUH, and assumed the role of Co-Chair of the Cancer Trials Ireland Breast Disease Specific Group in 2020. Prior to this, she was an associate professor of Oncology (Women’s Malignancy Program) from 2011, and Co-Director of the Developmental Therapeutics Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. Dr. Connolly graduated with a “first-class honors” medical degree from Trinity College, Dublin in 2001 and completed medical oncology fellowship training in both Ireland and at Johns Hopkins.
As a medical oncologist and clinical investigator, Dr. Connolly has significant expertise in the development of biomarkers of response to anti-cancer therapies, and the design and conduct of clinical trials that test investigational new drugs in the treatment of patients with both early- and late-stage cancers. In fact, she has led numerous multicenter clinical trials in collaboration with the Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute (NCI), the Translational Breast Cancer Research Consortium (TBCRC), and the Eastern Co-operative Oncology Group (ECOG-ACRIN) in the U.S. Dr. Connolly is Study Chair for the international phase III ECOG-ACRIN study and received the prestigious ECOG-ACRIN Young Investigator Award in 2019 for excellence in clinical investigation. She has also recently received an Irish Cancer Society grant to support a Women’s Cancer Survivorship Clinic in Cork, in collaboration with national and international teams.
Dr. Connolly has been awarded a Health Research Board grant to support the UCC Cancer Trials Group, a network of clinical trials units in the South of Ireland. Through this funding, she will lead the expansion and availability of innovative clinical trials and investigator-led clinical projects to reach patients in this region. In addition, this award will focus on training the next generation of cancer researchers and research staff. In 2022, she received dedicated funding for clinical research fellowships from Breakthrough Cancer Research.
