Immune checkpoints are a critical component of the body’s immune system and the mechanisms by which cancer escapes immune detection. Checkpoint inhibitors, such as those that target programmed death receptor-1 and its ligand (PD-1 and PD-L1), have changed the standard of care for multiple types of cancer and also represent a majority share of new cancer drug applications to FDA.
However, challenges that impede optimal clinical development and use of checkpoint inhibitor therapies for cancer include identifying patients who are most likely to benefit, assessing endpoints for safety and clinical benefit, overcoming resistance to therapy, and developing cancer site-agnostic indications. Opportunities for collaboration across industry, academia, and government in a precompetitive space could help advance this work.
The National Cancer Policy Forum will hold a public workshop on July 16-17, 2018 to examine the opportunities to improve the clinical development of immune checkpoint inhibitor therapies for cancer, including in the context of site-agnostic indications. Discussion will be focused on combination therapies that are built upon the backbone of anti-PD-1/PD-L1 strategies. The workshop will feature invited presentations and panel discussions on topics that may include the challenges and opportunities for improving:
- The development, validation, and standardization of biomarkers for patient selection.
- The assessment of safety and efficacy/clinical benefit in clinical trials.
- Innovations in clinical development programs for combination treatment strategies, such as approaches for prioritizing potential combinations (including multi-modal therapy), the role of preclinical modeling to identify promising combinations, and mechanisms for facilitating access to the best drug candidates for combination trials.
- Evidence requirements and decision making in drug development and regulatory evaluation for site-agnostic indications.
- Collaboration and information exchange among clinicians, researchers, and the pharmaceutical and diagnostic industries, including precompetitive collaboration, especially for the development of biomarkers predictive of immune-related toxicities and treatment response.
More information about the workshop can be found here.
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When: Monday, Jul. 16 - 12:00 pm
Tuesday, Jul. 17 3:30 pm
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