TY - JOUR
T1 - Neoadjuvant therapy for melanoma
T2 - A U.S. Food and drug administration⇔melanoma research alliance public workshop
AU - Mueller, Kristen L.
AU - Theoret, Marc R.
AU - Lemery, Steven J.
AU - Amiri-Kordestani, Laleh
AU - Ariyan, Charlotte E.
AU - Atkins, Michael B.
AU - Berry, Donald A.
AU - Blank, Christian U.
AU - DeMichele, Angela M.
AU - Forde, Patrick M.
AU - Ibrahim, Nageatte
AU - Keegan, Patricia
AU - Mitchell, Tara C.
AU - Moss, Rebecca A.
AU - Robert, Caroline
AU - Sridhara, Rajeshwari
AU - Taube, Janis M.
AU - Tetzlaff, Michael T.
AU - Wargo, Jennifer A.
AU - Flaherty, Keith T.
AU - Kaplan, Michael J.
AU - Topalian, Suzanne L.
AU - Ward, Ashley F.
AU - Hurlbert, Marc S.
N1 - Publisher Copyright:
© 2020 American Association for Cancer Research.
PY - 2021/1/15
Y1 - 2021/1/15
N2 - Tremendous progress has been made in treating patients with metastatic melanoma over the past decade. In that timeframe, the FDA has approved 12 novel treatments for patients with advanced unresectable melanoma, comprising both kinase-targeted therapies and immune checkpoint inhibitors (ICI), and five 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.
AB - Tremendous progress has been made in treating patients with metastatic melanoma over the past decade. In that timeframe, the FDA has approved 12 novel treatments for patients with advanced unresectable melanoma, comprising both kinase-targeted therapies and immune checkpoint inhibitors (ICI), and five 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.
UR - http://www.scopus.com/inward/record.url?scp=85100338748&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-20-3285
DO - 10.1158/1078-0432.CCR-20-3285
M3 - Review article
C2 - 33188142
AN - SCOPUS:85100338748
SN - 1078-0432
VL - 27
SP - 394
EP - 401
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 2
ER -