Dr. Kimberly Shafer-Weaver, a dedicated scientific leader, has committed her career to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Kimberly’s experience includes over 16 years in basic and translational research focused on immune response to cancer with a special emphasis on specific immune cells and overcoming immunological tolerance. She currently serves in the role of an Associate Director of Scientific Training for Immuno-Oncology at AstraZeneca, US Medical Affairs.
Kimberly has been the recipient of numerous awards, given several invited presentations, and is an author of peer-reviewed journal articles. Kimberly, is an active leader in the Society of Immunotherapy for Cancer (SITC) since 2001 including: Chair of the Early Career Scientists Committee, Trustee Committee, the Journal for ImmunoTherapy of Cancer (JITC) Editorial Board, Forward Fund committee, Council for Immunotherapy Education & Outreach and the Membership Committee. As Membership Chair, Kimberly oversaw a key initiative that expanded SITC membership to Nurses and Pharmacists.
Kimberly also serves on several editorial boards and scientific committees of other national and international societies. She holds a PhD in immunology from The George Washington University and performed her dissertation research at the National Cancer Institute within the Cancer Inflammation Program focusing on elucidating mechanisms of T cell tolerance in cancer. While at NCI, she also worked in the Laboratory of Cell-Mediated Immunity where she helped develop and CLIA certify immunoassays to support cancer immunotherapy trials. After completing her PhD, Kimberly joined Intrexon as the Clinical Immunology Manager and served as a subject matter expert for the cancer immunotherapy clinical trials and translational research studies. She returned to NIH as a Staff Scientist in the Laboratory of Immunology, NIAID, NIH focusing on immune tolerance in autoimmune diseases and served as the Program Director for Immunology, Oncology and Metabolic Disease at Health Analytics.
What are the two or three critical issues facing the field of cancer immunotherapy?
Discrepancy between immune and clinical responses. In the past decade, major advancements in cancer immunotherapy have occurred and many patients are benefiting from immuno-oncology (IO) therapies including durable responses. However, only a percentage of patients treated are responding to IO mainly due to tumor complexity, the tumor immunosuppressive tumor microenvironment, effects of conventional treatments, and potential therapy-related adverse events. This underscores the need to better understand the molecular and cellular events leading to tumor rejection or resistance to IO in patients. Such information should provide a better understanding of tumor classification for treatment and prediction of response, appropriate treatment regimes, and treatment scheduling/dosage thus enhancing patient outcomes to IO therapies (mono- or combination therapies). Insight gained from cancer modeling and big data analytics (real-world data) can be utilized to help drive more strategic/informed decisions, identify new potential drug candidates/combinations and predictive biomarkers that facilitate patient-treatment matching, clinical trial design, and perhaps help overcome the limitation of data obtained from murine cancer models. Combining insight from human cancer modeling, real world evidence, and clinical trials should drive improved patient care and the development and approval of effective, safe and reimbursed IO therapies for patients with cancer. SITC’s continued resolve towards combining basic tumor immunology research and clinical trial evidence to drive better patient outcomes is essential to overcoming these hurdles.
Immunotherapy in practice. The FDA approval of numerous immunotherapies for cancer, including checkpoint inhibitors, provides cancer patients access to immunotherapy beyond clinical trials. However, the field is facing challenges of successfully integrating IO into current models of cancer care and application in real-world practice has limited its access to appropriate cancer patients. To date, there is limited use of immunotherapies beyond large cancer centers. Significant hurdles to greater application of IO include, but are not limited to, a greater understanding the differences between immunotherapies and current standard of care combined with demonstrating a clear therapeutic benefit and better evidence of patient-treatment matching. In particular, education on the identification, differential diagnosis and management of immune-mediated adverse events (imAEs) is needed for both physicians and patients. Most imAE are low grade in severity and are manageable but if not properly managed symptoms can worsen to the point of irreversibility and treatment discontinuation. Insights into the use of immunotherapy for different minority groups and real-world evidence is warranted along with a fuller understanding of biomarkers for efficacy and safety selecting appropriate patients, treatment and management with IO therapies. Additionally, the cost of immunotherapy and reimbursement can also pose a significant challenge to its use in practice. SITC is poised to be a critical organization to drive appropriate immune-therapy education and practice guidance to these key stakeholders. The society has already demonstrated leadership to this end through it ACIs and SITC Cancer Immunotherapy CONNECT initiatives. Expansion or additions to the SITC programs, either independently or through collaborations, will be essential for greater application of immunotherapy especially in the community setting.
Ensuring the right patients, get the right treatment and the right time. There is evidence that the benefits of immunotherapy can be increased in certain populations of cancer patients through the use of combination therapies. Combining immunotherapies with conventional therapies (e.g. chemotherapies, radiation), targeted therapies, small molecule inhibitors or other immunotherapies is thought to broadening the group of responders thus improving response rate and duration of response, limiting the toxicity profiles, and overcoming resistance to single-agent therapy. Combination therapies should help to overcome, “cold tumors,” that have no immune response to stimulate, the immunosuppressive tumor microenvironment, or patients that relapsed after immunotherapy (~30% relapse rate in immunotherapy treated patients). The field is already seeing promise in applying the appropriate combination of immuno-modulatory therapeutics – a more personalized medicine approach. However, there are large hurdles to developing and running combination trials including appropriate preclinical models, determining appropriate dose levels, administration frequencies, durations of treatment, and sequence of administration. Changes in the healthcare landscape particularly political parties, regulations, policies and funding are also major hurdles to the driving novel combination therapies research, clinical trials and approval. This includes regulations at the preclinical level, such as pharmacologic and toxicology studies to estimate a safe dose for first-in-human trials through the clinical trial and post-marketing period. SITC is uniquely positioned to bring the right stakeholders from different sectors together (government, industry, regulatory, advocacy) to drive knowledge transfer and collaborations. SITC can serve as the central organization to use collective knowledge in a manner that will move the field forward.
What is your vision for SITC?
My vision is for SITC to continue to strengthen and increase its reputation and membership in the scientific community as one of the world’s leading organizations dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Beyond the annual scientific meeting, this can be accomplished through several SITC lead initiatives. 1) SITC’s continued resolve for educational and certification/accreditation programs. SITC should be recognized as the premier organization for the certification of healthcare professionals and researchers in immunotherapy for cancer through the development of programs aimed at community practices, ER and pharmacy groups, oncology nurses and patients and patient advocacy groups; 2) Continued and expanded strategic partnerships with other organizations to serve as the key partner or authority on tumor immunotherapy; and 3) to ensure that SITC has a seat at the table to shape guidelines, the regulatory landscape and payor reimbursement decisions. In short – my vision is that SITC recognized as the leading society to truly make the word “cure” a reality for cancer patients.