On February 11, 2021, Friends of Cancer Research (Friends) hosted a virtual meeting highlighting and discussing the progress, challenges, and future of immunotherapies and cell therapies. Ellen Sigal, Chairperson & Founder of Friends, gave opening remarks and introduced keynote speaker Ned Sharpless, Director of the National Cancer Institute (NCI). Sharpless spoke about the progress made to date in immuno-oncology (IO), ongoing efforts to advance the field at NCI, as well as regulatory challenges for IO and other novel therapies. He emphasized the important role Friends’ plays in driving collaborative work and partnerships to move the field forward.
“It is vital for us to collect data that is granular enough to allow us to pivot and adapt our evolving understanding of toxicities, especially for IO therapies.” – PK Morrow
After the keynote, Jeff Allen, President & CEO of Friends, introduced the first panel of the meeting, which highlighted the content of the working group’s white paper on harmonizing the characterization and reporting of unique toxicities in IO development. The panel consisted of working group members Bruce McCall of Genentech, Meredith Chuk of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), PK Morrow of Amgen, and Marcelo Pasquini of the Medical College of Wisconsin. First, McCall introduced some of the issues and solutions presented in the working group’s white paper such as principles for characterizing and reporting cytokine release syndrome (CRS) to better harmonize data collection in early development of novel therapies. The panel then discussed the transformational progress made to date in the development of novel IO agents and IO therapies’ impact on clinical treatment of cancer. The panelists highlighted the identification and mitigation of novel toxicities such as CRS as a key challenge in IO therapy development. The panelists emphasized the need to align on how these unique toxicities are characterized and reported and create a shared understanding of IO therapies’ safety and toxicity profiles. The panel concluded with a discussion on how better alignment in reporting of novel toxicities would support data driven interventions and patient mitigation strategies and refine labeling to better inform patient-provider treatment decisions.
“This is an area where even guidance we issue will have to be continually updated as we learn more. It is an area we will continue to work and listen in.” – Peter Marks
The second panel of the meeting, moderated by Anna Edney of Bloomberg News, looked toward the future of IO therapies in cancer. Panel members included Jennifer Malin of UnitedHealth Group, Peter Marks of the Center for Biologics Evaluation and Research (CBER) at FDA, Mark McClellan of the Duke-Margolis Center for Health Policy, and Renu Vaish of Kite, a Gilead Company. First, Marks provided a landscape of cell therapies over time and highlighted some of the innovations (e.g. manufacturing advances for CAR-T therapies) that supported their development. Next, the panelists discussed other opportunities for standardization in IO around manufacturing specifications, data to support regulatory decision making, and data in the post-market setting. To close, panelists discussed the future of cell therapies and the need for standardized processes that can be adapted with the evolving understanding of complex novel therapies.
“It is hard to overstate the impact the development of Immuno-Oncology drugs has had in changing clinical treatment of patients with cancer.” – Meredith Chuk
Jeff Allen closed the meeting by thanking key contributors and Friends’ staff involved with the white paper, working group, and virtual meeting. Be sure to read the white paper on harmonizing the definition and reporting of CRS in IO clinical trials. Also stay tuned for additional information and next steps here on our website and social media (Twitter and LinkedIn).