Leisha A. Emens, MD, PhD

Johns Hopkins University

At-Large Director Candidate

Biography

Leisha A. Emens, MD, PhD, is an Associate Professor of Oncology at the Kimmel Cancer Center at the Johns Hopkins University School of Medicine. After receiving her BA in Biochemistry and Cell Biology from the University of California at San Diego, she spent two years in industry working at Hybritech, Inc., a monoclonal antibody company. She then joined the Medical Scientist Training Program (MSTP) at Baylor College of Medicine, pursuing graduate work in immunology and cell biology. At Baylor, Dr. Emens served on the operating committee of the MSTP, and was named to the Alpha Omega Alpha (AOA) medical honor society. She received her MD and PhD in cell biology from Baylor College of Medicine and also completed a postdoctoral fellowship in oncology at the National Cancer Institute in 1993. She then completed residency training in internal medicine at the University of Texas at Southwestern before joining the fellowship programs in hematology and oncology at Johns Hopkins University School of Medicine in 1998. There, she trained in tumor immunology as a senior clinical and research fellow. She joined the faculty at Johns Hopkins University School of Medicine in 2001 as an Assistant Professor of Oncology.

Dr. Emens is currently board certified in both internal medicine and medical oncology and has been named a Castle Connolly Top Doctor for Cancer since 2011.  She is a member of the newly established Bloomberg Kimmel Institute for Cancer Immunotherapy at Johns Hopkins and a member of the Cancer Immunology and the Breast and Ovarian Cancer research programs. Dr. Emens is a practicing medical oncologist with an outpatient service focused on breast cancer and runs a research laboratory focused on translational immunotherapy for both breast and ovarian cancers. She is internationally recognized for her work in developing innovative combination immunotherapies that incorporate cancer vaccines, immune checkpoint inhibitors, and other immune modulators with standard and novel treatments for breast cancer. She developed a cytokine-secreting breast cancer vaccine for testing in clinical trials and identified an intravenous dose of cyclophosphamide of 200 mg/m² as most effective in reducing Treg activity and enhancing vaccine-induced CD8+ T cell responses. She also demonstrated that adding trastuzumab to vaccination can further enhance vaccine-induced CD8+ T cell responses in patients. Using delayed type hypersensitivity (DTH) as a real-time biomarker of vaccine-induced immunity, Dr. Emens demonstrated a possible clinical benefit associated with vaccine-induced DTH in these trials. In collaboration with Genentech and other academic investigators, she has most recently led the clinical development of atezolizumab, a PD-L1 antagonist, for breast cancer. Clinical trials testing combination immunotherapies with this agent in breast cancer are underway. With her pathology collaborators, she has characterized immune cell infiltrates and PD-L1 expression within breast ductal carcinoma in situ, invasive breast carcinoma, and matched primary invasive and metastatic breast cancers. Dr. Emens is now extending her translational work testing vaccines and blockade of the PD-1 pathway to ovarian cancer.

Dr. Emens has actively engaged the community in disseminating knowledge about cancer immunotherapy and in developing support for the development of new immuno-oncology approaches to cancer treatment. She has given public outreach presentations for a number of organizations, including the Alliance for Cancer Gene Therapy, Susan G. Komen for the Cure, the Metastatic Breast Cancer Network, the Cancer Research Institute, the National Breast Cancer Coalition Advocate Leadership Summit, and SHARE. She also recently presented on breast cancer immunotherapy to the Trout Financial Group. She has further engaged the community as a founding member of the Climb for Hope expedition climbing teams. Climb for Hope is an organization established to raise funds for the development of breast cancer immunotherapy at Johns Hopkins, using mountain climbing as a paradigm for personal challenge and leadership. Dr. Emens was an active member of the team soliciting pledges to raise funds to support immunotherapy research and was a full member of the climbing expeditions to Mt. Cotopaxi in Ecuador, Mt. Kilimanjaro in Africa, and Mt. Adams in Washington State.

Dr. Emens currently serves as chair of the Clinical Research Review Committee at the Kimmel Cancer Center at Johns Hopkins. She has served on the editorial board of the Journal of Clinical Oncology, is currently on the editorial board of Cancer Research and the Breast Journal. Importantly, she serves as section editor of the Clinical Trials Monitor section of the Journal for the Immunotherapy of Cancer (JITC), the voice of the Society for the Immunotherapy of Cancer (SITC). She is a former Chair of the Communications Committee for SITC and is currently Immediate Past Chair of the Stakeholder’s Council for SITC. Dr. Emens just completed a term from 2012-2016 as a member of the FDA Advisory Committee on Cellular, Tissue, and Gene Therapies. She is an active member of ASCO, AACR, and SITC and is a member of the Cancer Immunology (CIMM) Working Group of the AACR. Dr. Emens was awarded the President’s Award by the YWCA of Greater Baltimore and the Maryland Governor’s Citation for her work.

SITC Election Platform Statement

What are the two or three critical issues facing cancer immunotherapy?

This is a special time for cancer immunotherapy, which now clearly has the potential to transform cancer from a relentless disease that patients are constantly fighting into a well-controlled chronic medical condition. It is gratifying to see more and more patients living well with cancer, and we must continue to work diligently to extend these benefits of cancer immunotherapy to all patients. Accelerating clinical progress in immuno-oncology will require continued relentless effort and rapt attention to the most critical issues facing our field today. Three of the most critical challenges facing cancer immunotherapy are integration, personalization, and resource utilization.

Integration. Integration and interaction is the first core value of SITC, and remains the most critical element for the broad success of cancer immunotherapy. SITC has defined integration as facilitating the exchange of information and education among all stakeholders sharing the mission of SITC: making the cure for cancer a reality for patients everywhere. It is imperative to extend and deepen our efforts toward integration. We must continue to develop consensus guidelines for optimally implementing immuno-oncology in the clinic as the efficacy of immunotherapy extends to additional tumor types. We need to expand our educational outreach to physicians and researchers in other medical specialties who will encounter patients receiving cancer immunotherapy and who may collaborate in the management of the immune-related side effects associated with this modality. It is essential for us to capitalize on the breadth and depth of the immunotherapy drug pipeline by continuing to integrate and coordinate the talents, efforts, and resources of stakeholders in diverse disciplines in academia, biotechnology, pharma, and regulatory agencies. This includes elucidating the most promising treatment strategies that integrate novel immuno-oncology agents into combination immunotherapy regimens, developing novel endpoints for drug approval that reflect the unique mechanisms of action and patterns of response of cancer immunotherapies, and building new, integrated models for scientific, clinical, regulatory, and payor collaboration in drug development and dissemination into practice.

Personalization. Given the exquisite specificity of the immune system, there is probably no better way to personalize cancer care than through cancer immunotherapy. Recent data have revealed distinct patterns of immune cell infiltration into tumors, where tumors may lack T cell infiltrates and be immunologically “cold”, tumors may harbor significant numbers of immune cells and be immunologically “hot” or inflamed, or tumors may induce T cells that cannot enter the tumor microenvironment, and where the tumor remains “immune excluded”. Each of these immunologic phenotypes will likely demand a distinct strategy for effective combination cancer immunotherapy. In addition, advances in genomic technologies have created unprecedented opportunities for mapping the unique mutational and transcriptional landscape of a patient’s tumor. Proteins harboring somatic mutations are typically cancer cell specific, may be unique to the patient, and are more immunogenic than shared tumor antigens. Immunotherapies that can target immunogenic neoantigens are a major promising strategy for personalizing cancer immunotherapy. Furthermore, host factors such as the microbiome and genetic polymorphisms in immunoregulatory pathways or pathways of drug metabolism may shape the immune response to cancer. Mapping the unique features of a patient’s tumor and the host factors shaping the immune response to it should guide a personalized immunotherapeutic approach for each patient. Assembling the tools for gathering and integrating this information and developing the infrastructure for supporting personalized cancer immunotherapy, is a key priority for the field.

Resource utilization. With the success of cancer immunotherapy, resource utilization is a rapidly emerging challenge for the field. There are many immuno-oncology agents in development by multiple parties. The clinical trials testing them tend to be very large even at the earliest stages, and they frequently aim to test similar drugs in similar groups of patients. Judiciously applying scientifically rigorous adaptive trial designs, identifying predictive biomarkers of response, and characterizing biomarkers of both primary and acquired resistance to immunotherapy are key for the effective clinical development. This strategy will help prioritize the most promising agents and combinations to test, facilitating nimble and effective drug development. Finally, immuno-oncology agents are quite expensive once approved. It is very clear that the rising cost of medical care poses substantial challenges for society as a whole, and that the path we are on is not sustainable. Developing innovative models for reimbursement will therefore also be critical for the optimal application of cancer immunotherapy strategies in clinical care.

How do you feel the Society for Immunotherapy of Cancer would benefit from your involvement as an At-Large Director on the Board?

I have been a dedicated member of SITC since I joined the Society in 2002. I have played a key role in a number of initiatives designed to widely disseminate information and promote the integration of cancer immunotherapy into the broader community. I served as a panelist at the Workshop for Future Opportunities for the Combination Biological Therapy of Cancer in 2007. I served as a speaker and panelist in 2009 at a SITC/FDA/NCI-sponsored workshop on Therapeutic Cancer Vaccines. I participated in the Strategic Planning Retreats for SITC held in 2011 and 2014, which set critical priorities for the Society. In 2011, our task force identified both education and increased engagement of junior investigators as key strategic priorities for the Society to enhance scientific exchange and develop future leaders for the field. Building on these priorities, in 2012 I organized and chaired the SITC Workshop on the Tumor Microenvironment. From 2012-2014, I served as Chair of the Communications Committee, and from 2013-2016, I served as a leader of the Stakeholder’s Advisory Council for Immunotherapy Education and Outreach. During my leadership tenure, our groups developed the Advances in Cancer Immunotherapy (ACI) Lecture Series, a series of CME- and CNE-certified regional programs designed to introduce cancer immunotherapy to practicing clinicians involved in cancer care. I have served as a speaker or chair for the pre-ASCO ACI meetings in 2014, and 2015. I also spoke at the SITC/ASTRO-sponsored symposium on Immunotherapy and Radiotherapy Combinations in 2014. I was a speaker at the SITC/ASCO collaborative symposium in 2016 focused on integrating tumor immunotherapy into clinical practice and led a CME satellite symposium co-sponsored by SITC and PRIME Oncology on the Evolution of Cancer Immunotherapy at ASCO 2016. I participated in SITC-sponsored international programs, including both the International Symposium on Cancer Immunotherapy in London and the Breast Cancer Immunotherapy Symposium (BRECIS) in Doha, Qatar in 2015. In March 2016, I participated in the Radiation and Immunotherapy Leadership Summit co-sponsored by SITC/NCI. I served on the steering committee for the SITC/Kick-It Digital collaboration on the HealthQuest in Immuno-Oncology App that uses gamification to educate practicing oncologists about cancer immunotherapy and am also participating in the SITC/Medscape partnership. Importantly, since late 2013 I have served on the editorial board for JITC, the Society’s global voice and major outlet for disseminating knowledge and perspective on cancer immunotherapy. In 2014, the SITC strategic planning retreat focused on how to expand the scope and influence of the Journal. In late 2015 I became the section editor of a new section, the Clinical Trials Monitor. This section is designed to focus on newly approved immunotherapies, important clinical trials, and regulatory issues critical to the field.

It has been a privilege for me to be a member of SITC, and it is an honor to run as an At-Large Director candidate for the Board of Directors at this time of unprecedented opportunity in cancer immunotherapy. My long relationship with SITC, my translational perspective on cancer immunotherapy from bench to bedside, and my international leadership in cancer immunotherapy trials and education positions me well to continue engaging stakeholders across the enterprise to advance and grow the field. I will continue to serve SITC with great energy and enthusiasm.