RT Journal Article
SR Electronic
T1 Neoadjuvant Therapy for Melanoma: A US Food and Drug Administration - Melanoma Research Alliance Public Workshop
JF Clinical Cancer Research
JO Clin Cancer Res
FD American Association for Cancer Research
SP clincanres.3285.2020
DO 10.1158/1078-0432.CCR-20-3285
A1 Mueller, Kristen L
A1 Theoret, Marc R.
A1 Lemery, Steven J.
A1 Amiri-Kordestani, Laleh
A1 Ariyan, Charlotte E
A1 Atkins, Michael B.
A1 Berry, Donald A.
A1 Blank, Christian U.
A1 DeMichele, Angela
A1 Forde, Patrick M
A1 Ibrahim, Nageatte
A1 Keegan, Patricia
A1 Mitchell, Tara C
A1 Moss, Rebecca A
A1 Robert, Caroline
A1 Sridhara, Rajeshwari
A1 Taube, Janis M
A1 Tetzlaff, Michael T.
A1 Wargo, Jennifer A.
A1 Flaherty, Keith
A1 Kaplan, Michael J
A1 Topalian, Suzanne L.
A1 Ward, Ashley F.
A1 Hurlbert, Marc S
YR 2020
UL http://clincancerres.aacrjournals.org/content/early/2020/11/13/1078-0432.CCR-20-3285.abstract
AB Tremendous progress has been made in treating patients with metastatic melanoma over the past decade. In that timeframe, the US Food and Drug Administration (FDA) has approved 12 novel treatments for patients with advanced unresectable melanoma, comprising both kinase-targeted therapies and immune checkpoint inhibitors (ICI), and 5 treatments for adjuvant (postoperative) use in patients with high-risk resectable stage III melanoma. It is not known whether outcomes can be further improved by administering kinase inhibitors or ICI in the neoadjuvant (presurgical) setting in patients with high-risk resectable melanomas. Noting research community interest in exploring the neoadjuvant approach for treating melanoma and recognizing that early harmonization of methodologies may expedite the development of therapeutics in this space, the FDA and Melanoma Research Alliance convened a public workshop on November 6, 2019, in National Harbor, Maryland, to discuss key issues. The workshop consisted of 23 faculty and included more than 250 live participants. Topics discussed included opportunities for advancing novel endpoints for regulatory purposes as well as translational research, clinical trial design considerations, and strategies for optimizing patient selection while mitigating risk.