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 - Funding Information:
K.L. Mueller reports grants and other (scientific retreat sponsorship) from Bristol-Myers Squibb, Merck, and Novartis; other (scientific retreat sponsorship) from Amgen, Genentech, and Alkermes, and other (scientific retreat sponsorship and contracted patient focus group) from Pfizer outside the submitted work. M.B. Atkins reports grants and personal fees from Bristol-Myers Squibb (to institution, advisory board) and Merck (to institution, advisory board), and personal fees from Novartis (data and safety monitoring board), Genentech/Roche (advisory board), Pfizer (consultant), Eisai (advisory board), Exelixis (consultant), AstraZeneca (consultant), Agenus (consultant), Adagene (consultant), Aveo (advisory board), Array (advisory board), Pyxis Oncology (scientific advisory board), Leads BioPharma (advisory board), Werewolf (scientific advisory board), Elpis (scientific advisory board), TRV (scientific advisory board), PACT (data and safety monitoring board), and Iovance (consultant) outside the submitted work. D.A. Berry is co-owner of Berry Consultants, LLC, a company that designs adaptive Bayesian clinical trials for pharmaceutical and medical device companies, NIH cooperative groups, patient advocacy organizations, and international consortia. C.U. Blank reports advisory roles for Bristol-Myers Squibb, MSD, Roche, Novartis, GlaxoSmithKline, AstraZeneca, Pfizer, Lilly, GenMab, Pierre Fabre, and Third Rock Ventures, research funding from Bristol-Myers Squibb, Novartis, and NanoString, stock ownership in Uniti Cars, and is cofounder of Immagene B.V. A.M. DeMichele reports personal fees from Pfizer (honorarium: Asian Society of Clinical Oncology) and Context Therapeutics (scientific advising); other from Novartis (drug-only support for clinical trial); and grants (institutional support of clinical trial) from Calithera, Pfizer, and Genentech outside the submitted work. P.M. Forde reports other (consultant) from Amgen, Janssen, and Daichii; and grants and other (consultant) from AstraZeneca and Bristol-Myers Squibb outside the submitted work. N. Ibrahim reports employment with and stock from Merck. P. Keegan has left employment with the FDA since the completion of this article and is currently employed by TopAlliance Biosciences, a pharmaceutical company with clinical development in the field of medical oncology, including melanoma. T.C. Mitchell reports personal fees (honoraria for scientific advisory board) from Merck, Bristol-Myers Squibb, and OncoSec outside the submitted work. R.A. Moss reports full-time employment and stock ownership from Bristol-Myers Squibb during the conduct of the study. C. Robert reports personal fees (advisory boards) from Bristol-Myers Squibb, MSD, Roche, Sanofi, Pierre Fabre, Biothera, and Curevac outside the submitted work. J.M. Taube reports grants and other (consultant/ advisory board) from Bristol-Myers Squibb during the conduct of the study, as well as other (consultant/advisory board) from Merck and AstraZeneca outside the submitted work. M.T. Tetzlaff reports other from Nanostring (speaker), Novartis, LLC (advisory board), and Myriad Genetics (advisory board) outside the submitted work.
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
UR - http://www.scopus.com/inward/citedby.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 -