Tilsotolimod with Ipilimumab Drives Tumor Responses in Anti-PD-1 Refractory Melanoma.


Journal

Cancer discovery
ISSN: 2159-8290
Titre abrégé: Cancer Discov
Pays: United States
ID NLM: 101561693

Informations de publication

Date de publication:
08 2021
Historique:
received: 26 10 2020
revised: 08 02 2021
accepted: 09 03 2021
pubmed: 13 3 2021
medline: 26 2 2022
entrez: 12 3 2021
Statut: ppublish

Résumé

Many patients with advanced melanoma are resistant to immune checkpoint inhibition. In the ILLUMINATE-204 phase I/II trial, we assessed intratumoral tilsotolimod, an investigational Toll-like receptor 9 agonist, with systemic ipilimumab in patients with anti-PD-1- resistant advanced melanoma. In all patients, 48.4% experienced grade 3/4 treatment-emergent adverse events. The overall response rate at the recommended phase II dose of 8 mg was 22.4%, and an additional 49% of patients had stable disease. Responses in noninjected lesions and in patients expected to be resistant to ipilimumab monotherapy were observed. Rapid induction of a local IFNα gene signature, dendritic cell maturation and enhanced markers of antigen presentation, and T-cell clonal expansion correlated with clinical response. A phase III clinical trial with this combination (NCT03445533) is ongoing. SIGNIFICANCE: Despite recent developments in advanced melanoma therapies, most patients do not experience durable responses. Intratumoral tilsotolimod injection elicits a rapid, local type 1 IFN response and, in combination with ipilimumab, activates T cells to promote clinical activity, including in distant lesions and patients not expected to respond to ipilimumab alone.

Identifiants

pubmed: 33707233
pii: 2159-8290.CD-20-1546
doi: 10.1158/2159-8290.CD-20-1546
pmc: PMC8544022
mid: NIHMS1742700
doi:

Substances chimiques

Immune Checkpoint Inhibitors 0
Ipilimumab 0
tilsotolimod 0

Types de publication

Clinical Trial, Phase I Clinical Trial, Phase II Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1996-2013

Subventions

Organisme : NCI NIH HHS
ID : P30 CA016672
Pays : United States
Organisme : NCI NIH HHS
ID : P50 CA221703
Pays : United States
Organisme : NCI NIH HHS
ID : U24 CA224285
Pays : United States

Informations de copyright

©2021 American Association for Cancer Research.

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Auteurs

Cara Haymaker (C)

Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Daniel H Johnson (DH)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Ravi Murthy (R)

Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Salah-Eddine Bentebibel (SE)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Marc I Uemura (MI)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Courtney W Hudgens (CW)

Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Houssein Safa (H)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Marihella James (M)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Robert H I Andtbacka (RHI)

Surgical Oncology Department of Surgery, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.

Douglas B Johnson (DB)

Division of Oncology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.

Montaser Shaheen (M)

Department of Medicine and Cancer Center, University of Arizona, Tucson, Arizona.

Michael A Davies (MA)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Shah Rahimian (S)

Idera Pharmaceuticals, Inc., Exton, Pennsylvania.

Srinivas K Chunduru (SK)

Idera Pharmaceuticals, Inc., Exton, Pennsylvania.

Denái R Milton (DR)

Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Michael T Tetzlaff (MT)

Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Willem W Overwijk (WW)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Patrick Hwu (P)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Nashat Gabrail (N)

Department of Oncology, Gabrail Cancer Center, Canton, Ohio.

Sudhir Agrawal (S)

Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.

Gary Doolittle (G)

Department of Oncology, University of Kansas Medical Center, Kansas City, Kansas.

Igor Puzanov (I)

Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York.

Joseph Markowitz (J)

Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.

Chantale Bernatchez (C)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. adiab@mdanderson.org cbernatchez@mdanderson.org.

Adi Diab (A)

Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. adiab@mdanderson.org cbernatchez@mdanderson.org.

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