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FDA-MRA Approaches to Neoadjuvant Treatment in Melanoma: A Public Workshop
Twitter: #MelanomaNeoadjuvant

Co-Sponsored by the:
U.S. Food & Drug Administration (FDA) and

Melanoma Research Alliance (MRA)

Workshop Co-Chairs:

• Ashley Ward, MD – U.S. FDA
• Marc Hurlbert, PhD – MRA
• Suzanne Topalian, MD - Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy

Date:            November 6, 2019 

Time:           7:00 am to 2:00 pm Eastern Time

Location:

Westin National Harbor
Potomac Ballroom
171 Waterfront Street
National Harbor, MD 20745
301-567-3999

Registration:
If you wish to attend the public workshop, please register at the following link by Wednesday November 4, 2019 at 5:00 p.m. Eastern Time:

https://www.cvent.com/c/express/584a0782-4515-4981-a13a-709e734a0ac6

Background: 

The FDA and MRA are leveraging their combined strengths to host a public workshop on neoadjuvant therapy in melanoma. The workshop seeks to identify, discuss, and address key issues, challenges, and opportunities faced by industry, regulatory, and academic partners—along with the concerns and interests of patients and patient advocates—in the pursuit of neoadjuvant therapies for surgically resectable melanoma.

Early clinical studies suggest that neoadjuvant therapy, delivered prior to surgery, might enhance recurrence-free survival (RFS) for patients with melanoma at high risk of disease recurrence. However, there is limited opportunity to evaluate the utility of novel biomarkers and endpoints in these studies as many of these trials are relatively small and often from single institutions. Additional challenges include substantial heterogeneity across trials in patient populations, endpoints, endpoint assessment methods, and robustness of data collection.

A concerted effort across stakeholders to standardize novel, early efficacy endpoint(s) (e.g., pathologic complete response), and key biomarker evaluation (e.g., circulating tumor DNA) has the potential to improve outcomes with neoadjuvant treatment in patients with melanoma by providing the collective evidence needed to evaluate appropriate clinical trial endpoints, enhance patient selection, and optimize treatment regimens and trial designs. Effective neoadjuvant therapy is of high interest to the melanoma field and a thorough discussion among key stakeholders is warranted to review the existing and forthcoming clinical evidence, and develop recommendations for advancing neoadjuvant therapies.

Workshop Goals and Objectives:

The workshop will address:

• Current methods for assessing the efficacy of neoadjuvant therapies for melanoma; 
• Opportunities for advancing novel efficacy endpoints (e.g. pathologic complete response) in the development of treatments for patients with melanoma in this setting;
• Trial design and trial conduct considerations in this setting; and
• Strategies for optimizing patient selection and mitigating risks in the evaluation of neoadjuvant melanoma treatments.

Webcast Information:

A free-of-charge webcast of this workshop will be provided for those unable to attend in person. Registration for the webcast is required.

FDA and MRA plans to post archived webcasts after the meeting, however, in cases where the transmission was not successful, archived webcasts will not be available. The link for the webcast will be provided to all registered no less than 24 hours prior to the start of the workshop.

Workshop Information: (documents will be added when available)

• Agenda
• Participant List – coming soon
• Speaker biographies – coming soon

Contacts:
Sonia C. Swayze
Regulatory Health Project Manager/Oncology Program
Oncology Center of Excellence (OCE) / FDA
Email: [email protected] 
Phone: 301-796-6132
Website: www.fda.gov

Marc Hurlbert, PhD 
Chief Science Officer 
Melanoma Research Alliance 
Email: [email protected]
Phone: 202-336-7230 
Website: www.curemelanoma.org 

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