Dec. 9–10, 2020 • Virtual Program
- David Kaufman, MD, PhD – Third Rock Ventures
- Samir Khleif, MD – Georgetown University
Access to cancer immunotherapies, particularly PD-1 checkpoint blockade, is restricted in low- and middle-income countries (LMIC) relative to high-income countries (HIC). Aside from health economic barriers, key issues that need to be addressed to facilitate access include: defining the minimal hospital, staff and pharmacy requirements for safe administration and monitoring of therapy; understanding how specific co-morbidities, environmental factors and local cancer epidemiology influence the safety and efficacy profile of cancer immunotherapy; understanding the regulatory and EC/IRB requirements to study and ultimately register novel immunotherapies in LMIC; and determining the most impactful approaches to provider and community education.
The purpose of this convening is to bring together immunotherapy experts from HIC with experts on cancer delivery and research from LMIC to define optimal approaches to the above challenges. The meeting will focus on the scientific, educational and implementation barriers described above, rather than health economics and sustainable funding, with the belief that addressing the former will create more momentum to solve for the latter.
High-Level Workshop Topics
- Defining minimal monitoring requirements for starting and maintaining patients on PD-1 checkpoint blockade
- Defining minimal pharmacopeia for treating transient and irreversible immunotherapy-related adverse events. Oncologic emergencies—are there systems in place to identify patients with SAEs/irAEs?
- Current/projected status of health care systems—how is checkpoint blockade playing out in settings where it has been recently implemented? In what settings currently without access to cancer immunotherapies can the above standards be sustainably met?
- Approaches to assessing the impact of co-infections (TB, HIV, malaria, etc.), malnutrition and other environmental factors on the efficacy and safety of immunotherapy
- Cancer epidemiology: What are the leading cancer types that are potentially responsive to checkpoint blockade immunotherapy? Are there unique clinical or molecular epidemiologic features of these cancers in particular LMIC settings? Is PD-(L)1 monotherapy or a combo approach desirable? Are there novel cancer types/subtypes where additional clinical trials warranted?
- Regulatory, EC/IRB, patient recruitment, community education, provider education: considerations for running implementation studies, clinical trials or rolling out immunotherapy in LMIC settings
- Stakeholder education needs: patients, providers, IRBs/regulators, government officials, etc.
Desired Workshop Outputs
- Equity of access and optimization of risk/benefit in LMIC should be the guiding principle for next steps
- Draft guidance for clinical trial/demonstration project execution in LMIC
- Consensus topics (high level) for LMIC community and provider education materials, including the desirability of region-specific materials
- Assessment of need for developing region-specific immunotherapy guidelines
- Consolidated list of key areas for further scientific/clinical/operations research
- List of key regulatory issues that will facilitate guidance of CTA submission and registration