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Purpose: To evaluate linrodostat mesylate, a selective, oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, combined with nivolumab ± ipilimumab in advanced solid tumors and hematologic malignancies.
Patients And Methods: In this phase 1/2 study, patients received once-daily (QD) linrodostat (part 1 [escalation], 25-400 mg; part 2 [expansion], 100 or 200 mg) plus nivolumab (480 mg every [Q] 4 weeks [W] or 240 mg Q2W) or triplet therapy (part 3, linrodostat 20-100 mg QD; nivolumab 360 mg Q3W or 480 mg Q4W; ipilimumab 1 mg/kg Q6W or Q8W). Endpoints included safety and efficacy (co-primary; parts 2, 3), pharmacokinetics, pharmacodynamics, biomarkers, and efficacy (part 1).
Results: Fifty-five, 494, and 41 patients were enrolled in parts 1, 2, and 3, respectively. Linrodostat exposures exceeded predicted therapeutic target concentrations starting at 50 mg. Rates of grade 3/4 adverse events were 50.1%-63.4%. The maximum tolerated linrodostat dose was 200 mg; dose-limiting toxicities were primarily immune related. Responses were observed across different cohorts, study parts, and tumor types, particularly in immunotherapy-naive patients. Kynurenine decreased with linrodostat + nivolumab, regardless of response. In contrast, interferon gamma (IFN-γ) gene expression signature was associated with response; in nonmelanoma patients, a composite of low tryptophan 2,3-dioxygenase (TDO2) gene expression plus high IFN-γ signature was associated with response.
Conclusions: Linrodostat + nivolumab ± ipilimumab demonstrated a manageable safety profile. Kynurenine changes supported IDO1 pathway inhibition but did not correlate with response. A composite biomarker of low TDO2 expression plus high IFN-γ gene expression may predict response to linrodostat + nivolumab.
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http://dx.doi.org/10.1158/1078-0432.CCR-24-0439 | DOI Listing |
J Am Heart Assoc
December 2024
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital, Harvard Medical School Boston MA.
Background: Immune checkpoint inhibitors have improved the clinical outcomes of several cancers but have also been associated with a greater risk of immune-related adverse effects, especially when combined. The objective of this study was to investigate the incidence of myocarditis in relation to the use of dual concurrent versus single immune checkpoint inhibitors therapies.
Methods And Results: A cohort study was conducted using medical and pharmacy claims data (2011-2022) from a large US commercial insurer.
Eur J Cancer
November 2024
University of Perugia, Unit of Medical Oncology, Santa Maria della Misericordia Hospital, Perugia, Italy.
A unique collaboration of multi-disciplinary experts from the European Association of Dermato-Oncology (EADO), the European Dermatology Forum (EDF), and the European Organization of Research and Treatment of Cancer (EORTC) was formed to make recommendations on cutaneous melanoma diagnosis and treatment, based on systematic literature reviews and the experts' experience. Cutaneous melanomas are excised with one to two-centimeter safety margins. For a correct stage classification and treatment decision, a sentinel lymph node biopsy shall be offered in patients with tumor thickness ≥ 1.
View Article and Find Full Text PDFJCO Clin Cancer Inform
December 2024
Ontada, Boston, MA.
Purpose: Nivolumab plus ipilimumab (NIVO + IPI) is a first-in-class combination immunotherapy for the treatment of intermediate- or poor (I/P)-risk advanced or metastatic renal cell carcinoma (mRCC). Currently, there are limited real-world data regarding clinical effectiveness beyond 12-24 months from treatment initiation. In this real-world study, treatment patterns and clinical outcomes were evaluated for NIVO + IPI in a community oncology setting.
View Article and Find Full Text PDFDiscov Oncol
December 2024
Division of Medical Oncology, Department of Internal Medicine, Ege University Medical Faculty, Izmir, 35100, Turkey.
Immune checkpoint inhibitors (ICIs) have significantly improved the five-year survival rate for advanced melanoma. However, many patients exhibit resistance to ICI therapy. This study evaluated the efficacy and prognostic factors of anti-PD-1 (Group A) and nivolumab-ipilimumab (Group B) therapy in patients with advanced melanoma who were resistant to prior ICI therapy.
View Article and Find Full Text PDFAsia Pac J Clin Oncol
December 2024
Department of Internal Medicine, Division of Medical Oncology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Aim: The response rates to immune checkpoint inhibitors (ICI) remain low (13%-20%) in metastatic head and neck cancer patients, indicating an urgent need to better understand factors predictive of response to these agents. This study explored the impact of smoking status, marijuana use, and alcohol consumption on treatment outcomes in recurrent-metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients treated with ICI.
Methods: A retrospective analysis was performed on 201 R/M HNSCC patients treated with ICI between January 15th 2016 and April 9th 2020 at a single institution.
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