A Message from the President

Dear Colleagues,

While I hope that you all have been enjoying a little slow down during this summer, I want you to know that the Society for Immunotherapy of Cancer (SITC) never sleeps! SITC’s membership has for the first time exceeded 2,000 members, and we are working to ensure our members’ voice is heard by policymakers in our nation’s capital throughout the year. During the past months, SITC has increased its efforts in the policy and advocacy realm. We have added staff dedicated to managing these complex interactions and continued to work with the consulting firm, Cornerstone Government Affairs, LLC, to support our viewpoints in Washington, D.C.

Recently, the SITC Board of Directors helped to define and expand the efforts of our society’s Policy and Advocacy Committee by adding three subcommittees. These subcommittees will conduct work and report on three distinct areas of the field: science and research, regulatory and quality.

This group has made great progress on a number of issues in the past year, including:

• Successfully advocating for an increase in funding for the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) in Fiscal Year 2019 (from $15 million to $20 million)
• SITC-proposed language accepted verbatim in a pair of reports to advocate on behalf of our members and apprise decision makers of field expert opinions on critical issues affecting all aspects of the cancer immunotherapy field, including:
  • An FDA report on the need to develop standardized templates for reporting toxicities in cancer immunotherapy clinical trials (view SITC language, accepted in May 2018, here)
  • A National Institutes of Health-National Cancer Institute (NIH-NCI) report on the need to prioritize research and education on the underlying mechanisms of cancer immunotherapy toxicities and training for young and mid-career investigators (view SITC language, accepted in June 2018, here)
• A July 2017 response letter to the Congress Healthcare Innovative Caucus (request for comment here) regarding value-based provider payment reform
• A June 2018 response letter to the Centers for Medicare & Medicaid Services regarding the National Coverage Analysis for CAR T therapies

SITC also continues to strengthen relationships with partnering organizations.

SITC is pleased to partner with Friends of Cancer Research (FOCR) to address critical issues regarding the value of immunotherapy and immuno-oncology agents. Through this collaboration, SITC and FOCR will review current value models and provide guidance on redefining value frameworks for the unique aspects of cancer immunotherapy. This effort will ensure patients and healthcare professionals have the appropriate information to make informed treatment decisions and have access to high-quality treatment options.

SITC is working with the FDA to provide education to employees on critical aspects of cancer immunotherapy research while also collaborating strategically to positively affect the future of the field. We met with FDA leaders July 18 to discuss several initiatives of common interest and will return to the FDA campus on Sept. 17 to give FDA OCE Rounds. These visits will be regular events going forward to keep our interactions effective and timely.

Cancer immunotherapy has to evolve on all fronts to have the optimal impact on patients. The work of SITC’s policy committee and our FDA collaborations will address important aspects of the field that compliment all of the work you are all doing in your labs, clinics and offices.

Sincerely,

Lisa H. Butterfield, PhD

SITC President

3 SITC Policy and Advocacy Subcommittees Created

To support the efforts of the SITC Policy and Advocacy Committee, SITC has launched a trio of subcommittees that will define the positions and recommendations of the society on three distinct areas of the field: science and research, regulatory and quality.

The following are the policy statements of these three subcommittees to further explain their foci:

Science and Research Subcommittee Policy Statement

Cancer immunotherapy is one of the most promising new discoveries for the treatment of cancer. With its exciting potential, there is still much to be learned about immuno-oncology. These biologic therapies offer many cancer patients the potential for shorter treatment time and improved quality of life, with long term, progression and/or treatment free survival. While some cancer immunotherapy side effects can be severe and long-lasting, most side effects can be managed effectively if properly recognized and addressed.

SITC understands that continued and expanded research is needed to understand response and resistance, and to identify biomarkers that will assist in patient selection and improvement of patient outcomes. SITC is committed to advocating for long-term, increased, sustainable funding at the NIH and NCI to support research in the areas of greatest need for the advancement of cancer immunotherapy.

Regulatory Subcommittee Policy Statement

With the rapid innovation in oncology and development of new drugs and treatment, quality of care has become a priority in healthcare payment reform to increase patient access, reduce costs and achieve desired health outcomes. SITC is committed to collaborate with Center for Medicare & Medicaid Services (CMS), quality improvement organizations, and engage with private payers in healthcare quality and assessment related activities to make recommendations when input is needed, educate stakeholders and policy makers, and better articulate the value of cancer immunotherapy.

In addition to the scientific research still needed to answer the questions in the field, SITC is also committed to harmonizing, analyzing, and sharing clinical trial data and real world data to improve safety and efficacy in the development and application of cancer immunotherapy.

Quality Subcommittee Policy Statement

Oncology drugs follow study designs established in the 1940s, which were intended for cytotoxic chemotherapy. On the basis of the unique scientific attributes of cancer immunotherapy, SITC will collaborate with the appropriate government agencies to improve the drug development, review, and approval process to reflect the distinctly different biologics and mechanisms of action of cancer immunotherapy.

SITC will strive to advance the science and application of cancer immunotherapies by appropriately analyzing clinical trial data and real world data to improve the patient experience and their outcomes.

SITC will advocate for long-term, increased, sustainable funding to support the efforts of the FDA to continue advancing life-saving cancer immunotherapies.

Visit SITC CONNECT to learn more about these SITC subcommittees.