Targeting Replication Stress and Chemotherapy Resistance with a Combination of Sacituzumab Govitecan and Berzosertib: A Phase I Clinical Trial.


Journal

Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500

Informations de publication

Date de publication:
15 09 2023
Historique:
received: 25 02 2023
revised: 06 04 2023
accepted: 03 05 2023
pmc-release: 15 03 2024
medline: 18 9 2023
pubmed: 25 5 2023
entrez: 25 5 2023
Statut: ppublish

Résumé

Despite promising preclinical studies, toxicities have precluded combinations of chemotherapy and DNA damage response (DDR) inhibitors. We hypothesized that tumor-targeted chemotherapy delivery might enable clinical translation of such combinations. In a phase I trial, we combined sacituzumab govitecan, antibody-drug conjugate (ADC) that delivers topoisomerase-1 inhibitor SN-38 to tumors expressing Trop-2, with ataxia telangiectasia and Rad3-related (ATR) inhibitor berzosertib. Twelve patients were enrolled across three dose levels. Treatment was well tolerated, with improved safety over conventional chemotherapy-based combinations, allowing escalation to the highest dose. No dose-limiting toxicities or clinically relevant ≥grade 4 adverse events occurred. Tumor regressions were observed in 2 patients with neuroendocrine prostate cancer, and a patient with small cell lung cancer transformed from EGFR-mutant non-small cell lung cancer. ADC-based delivery of cytotoxic payloads represents a new paradigm to increase efficacy of DDR inhibitors. See related commentary by Berg and Choudhury, p. 3557.

Identifiants

pubmed: 37227187
pii: 726931
doi: 10.1158/1078-0432.CCR-23-0536
pmc: PMC10524218
mid: NIHMS1900404
doi:

Substances chimiques

sacituzumab govitecan M9BYU8XDQ6
berzosertib L423PRV3V3
Camptothecin XT3Z54Z28A
Immunoconjugates 0

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, N.I.H., Intramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

3603-3611

Subventions

Organisme : Intramural NIH HHS
ID : ZIA BC011793
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

©2023 American Association for Cancer Research.

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Auteurs

Melissa L Abel (ML)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Nobuyuki Takahashi (N)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.
Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Cody Peer (C)

Clinical Pharmacology Program, National Cancer Institute, NIH, Bethesda, Maryland.

Christophe E Redon (CE)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Samantha Nichols (S)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Rasa Vilimas (R)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Min-Jung Lee (MJ)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Sunmin Lee (S)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Meenakshi Shelat (M)

Pharmacy Department, National Institutes of Health Clinical Center, Bethesda, Maryland.

Robbie Kattappuram (R)

Pharmacy Department, National Institutes of Health Clinical Center, Bethesda, Maryland.

Linda Sciuto (L)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Danielle Pinkiert (D)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Chante Graham (C)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Donna Butcher (D)

Molecular Histopathology Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.

Baktiar Karim (B)

Molecular Histopathology Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.

Ajit Kumar Sharma (AK)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Justin Malin (J)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Rajesh Kumar (R)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Christopher W Schultz (CW)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Shubhank Goyal (S)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Jaydira Del Rivero (J)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Manan Krishnamurthy (M)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Deep Upadhyay (D)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Brett Schroeder (B)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Tristan Sissung (T)

Clinical Pharmacology Program, National Cancer Institute, NIH, Bethesda, Maryland.

Manoj Tyagi (M)

Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Jung Kim (J)

Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Yves Pommier (Y)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Mirit Aladjem (M)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Mark Raffeld (M)

Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

William Douglas Figg (WD)

Clinical Pharmacology Program, National Cancer Institute, NIH, Bethesda, Maryland.

Jane Trepel (J)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Liqiang Xi (L)

Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Parth Desai (P)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

Anish Thomas (A)

Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland.

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Classifications MeSH