TY - JOUR
T1 - Advancing drug development in gynecologic malignancies
AU - Beaver, Julia A.
AU - Coleman, Robert L.
AU - Arend, Rebecca C.
AU - Armstrong, Deborah K.
AU - Bala, Sanjeeve
AU - Mills, Gordon B.
AU - Sood, Anil K.
AU - Herzog, Thomas J.
N1 - Funding Information:
R.L. Coleman receives support from the Judy Reis/Al Pisani, MD Ovarian Cancer Research Fund, the Ann Rife Cox Chair in Gynecology, NCI grant P50CA217685, and CPRIT RP210214. G.B. Mills received support from a kind gift from the Adelson Medical Research Foundation, support from the Ovarian Cancer Research Foundation and NCI grants: 1P50CA217685, 1U01CA217842, and P50CA098258. A.K. Sood received support from the NCI grants P50CA217685, P50CA098258, and R35CA209904; American Cancer Society Research Professor Award; and the Frank McGraw Chair in Cancer Research.
Funding Information:
R.L. Coleman reports receiving commercial research grants from Abbvie, AstraZeneca, Gateway Foundation, Clovis, Genentech, Genmab, Janssen,
Publisher Copyright:
2019 American Association for Cancer Research.
PY - 2019/8/15
Y1 - 2019/8/15
N2 - Gynecologic malignancies continue to be a major cause of morbidity and mortality in the United States despite recent advances in oncologic therapies. To realize the promise of immunotherapy and biomarker-driven approaches to improve clinical outcomes for patients, better communication among stakeholders in the drug development and approval pathways is needed. To this end, the FDA-AACR-SGO Drug Development in Gynecologic Malignancies Workshop brought together clinicians, patient advocates, researchers, industry representatives, and regulators in June 2018, to review the state of the science in gynecologic cancers and explore how scientific advances impact approval processes. Topics of discussion and key takeaways are summarized in this Perspectives in Regulatory Science and Policy article. Single-agent immunotherapies have demonstrated variable and often modest response rates among gynecologic cancers. Combination therapies and other novel approaches, such as cell-based therapies, may show improved efficacy compared with single-agent immunotherapies; however, utilizing innovative clinical trial designs will be necessary to progress further. Companion and complementary diagnostics inform physicians of potential benefits of specific therapeutics for patients; however, they serve different functions that have important regulatory implications, thus trialists should understand the distinctions between diagnostic types. PARP inhibitors hold great promise for treating ovarian cancers, both as monotherapies and in combination with chemotherapeutics, other targeted agents, and immunotherapies. Rare gynecologic cancers often exhibit unique molecular characteristics that can serve as effective targets to which novel therapeutics can be developed. This workshop highlighted the importance of future open discussions on scientific and regulatory challenges in drug development for gynecologic malignancies.
AB - Gynecologic malignancies continue to be a major cause of morbidity and mortality in the United States despite recent advances in oncologic therapies. To realize the promise of immunotherapy and biomarker-driven approaches to improve clinical outcomes for patients, better communication among stakeholders in the drug development and approval pathways is needed. To this end, the FDA-AACR-SGO Drug Development in Gynecologic Malignancies Workshop brought together clinicians, patient advocates, researchers, industry representatives, and regulators in June 2018, to review the state of the science in gynecologic cancers and explore how scientific advances impact approval processes. Topics of discussion and key takeaways are summarized in this Perspectives in Regulatory Science and Policy article. Single-agent immunotherapies have demonstrated variable and often modest response rates among gynecologic cancers. Combination therapies and other novel approaches, such as cell-based therapies, may show improved efficacy compared with single-agent immunotherapies; however, utilizing innovative clinical trial designs will be necessary to progress further. Companion and complementary diagnostics inform physicians of potential benefits of specific therapeutics for patients; however, they serve different functions that have important regulatory implications, thus trialists should understand the distinctions between diagnostic types. PARP inhibitors hold great promise for treating ovarian cancers, both as monotherapies and in combination with chemotherapeutics, other targeted agents, and immunotherapies. Rare gynecologic cancers often exhibit unique molecular characteristics that can serve as effective targets to which novel therapeutics can be developed. This workshop highlighted the importance of future open discussions on scientific and regulatory challenges in drug development for gynecologic malignancies.
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U2 - 10.1158/1078-0432.CCR-19-0619
DO - 10.1158/1078-0432.CCR-19-0619
M3 - Article
C2 - 31126961
AN - SCOPUS:85070695295
VL - 25
SP - 4874
EP - 4880
JO - Clinical Cancer Research
JF - Clinical Cancer Research
SN - 1078-0432
IS - 16
ER -