Developmental Therapeutics Symposium

Course Description

The goals of this activity are to help participants examine synthesized data from completed studies, discuss the novel investigational agents available in ongoing clinical trials, and describe the rational for and results of studies that include novel agents for the treatment of patients with advanced cancer. This knowledge will enable them to appropriately utilize new treatments available to cancer patients, provide support for current and future oncology clinical trials, and become stronger leaders in the area of oncology research. In sum, this program will convey information on how to better implement precision medicine in oncologic care, leading to better outcomes for patients suffering from cancer.

Learning Objectives

After this activity, participants will be able to:

• Summarize current approaches to pre- and post-FDA approval dosing and scheduling of emerging anti-cancer agents to optimize therapeutic decision-making for patients with cancer.

• Describe the mechanisms and clinical effects of novel immunotherapeutics, including checkpoint inhibitors, bispecific antibodies, and cellular therapies, to inform evidence-based treatment planning and improve patient outcomes.

• Apply principles of molecular oncology to select systemic therapies that target genomic alterations, enhancing precision medicine-based patient management.

• Analyze the developmental pathways and clinical rationale for antibody-drug conjugates in solid and hematologic malignancies to support evidence-informed therapeutic choices.

• Evaluate patient suitability for ongoing and upcoming clinical trials by interpreting next-generation sequencing results and eligibility criteria to advance equitable and appropriate clinical trial enrollment strategies.

• Integrate pharmacologic, biologic, and imaging-based data through structured interpretation to construct evidence-informed considerations for the use of novel anti-cancer agents to strengthen early-phase therapeutic decision-making.

Goals

Practice Gap/Needs Assessment

Oncology providers and patients face constantly evolving standards of care. In the first 11 months of 2025 alone, the FDA approved 15 new oncologic therapeutics.1 New research is continuously published at a rate that makes it difficult for practicing physicians to stay current. Oncologists have traditionally learned treatment algorithms based on the cancer organs of origin, but now they need to also consider molecular and immunological phenotypes in their therapeutic decision-making, with pembrolizumab use in microsatellite instability-high tumors just one example.2 Finally, the number of clinical trials available to further enhance care continues to increase, while enrollment has relatively stagnated, in part because it is challenging to understand how to put these trials in the context of multiple new emerging standards of care.

The planning committee reviewed publications in the field, including but not limited to those in the Journal of Clinical Oncology, Blood, Blood Advances, Clinical Cancer Research, Cancer, JAMA Oncology, Lancet Hematology, and Lancet Oncology, conducted informal surveys of disease-oriented sub-specialists, attended disease program meetings, and consulted with research collaborators to determine the latest developments and ongoing research in the area of oncology therapeutics that is addressing the current therapeutic gaps. Identified areas of high unmet educational needs include the application of somatic genomic tests in the development of targeted therapeutics,3 the gut microbiome and impact on cancer, immune responses and immunotherapy, 4 progress and challenges of novel cellular therapies,5 the potential role for targeting components of the epigenetic machinery,6 and the expanding role of bispecific7 and antibody-drug conjugate therapy.8

1. Novel Drug Approvals for 2024.

Available at: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025: Accessed 11/18/25.

2. Maio, et al. Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. Ann Oncol. (2022) 33(9):929-938. doi: 10.1016/j.annonc.2022.05.519.

3. Arber, et al. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data. Blood (2022) 140 (11): 1200–1228. doi.org/10.1182/blood.2022015850

4 Nobles A et al, The gut microbiome and cancer: from tumorigenesis to therapy. Nature Metabolism (2025) 7: 895-917 https://doi.org/10.1038/s42255-025-01287-w

5. Swan D et al. CAR T cell therapy in multiple myeloma: current status and future challenges. Blood Cancer Journal (2024) 14, 206. https://doi.org/10.1038/s41408-024-01191-8

6.Huls G et al. Menin inhibitors in the treatment of acute myeloid leukemia.  Blood (2025)145 (6):561-566

7. Klein, et al. The present and future of bispecific antibodies for cancer therapy. Nature Reviews Drug Discovery volume 23, pages 301–319 (2024). doi.org/10.1038/s41573-024-00896-6

8. Shastry, et al. Rise of Antibody-Drug Conjugates: The Present and Future. American Society of Clinical Oncology Educational Book (2023). 43:1-15.  doi.org/10.1200/EDBK_390094

Outcomes