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Axitinib in Combination With Toripalimab, a Humanized Immunoglobulin G4 Monoclonal Antibody Against Programmed Cell Death-1, in Patients With Metastatic Mucosal Melanoma: An Open-Label Phase IB Trial
Open accessAbstract
PURPOSE: Metastatic mucosal melanoma responds poorly to anti–programmed cell death-1 (PD-1) monotherapy. Vascular endothelial growth factor (VEGF) has been shown to play an important immunosuppressive role in the tumor microenvironment. The combination of VEGF inhibition and PD-1 blockade provides therapeutic opportunities for patients refractory to either therapy alone. PATIENTS AND METHODS: We conducted a single-center, phase IB trial evaluating the safety and preliminary efficacy of toripalimab, a humanized immunoglobulin G 4 monoclonal antibody against PD-1 in combination with the VEGF receptor inhibitor axitinib in patients with advanced melanoma, including patients with chemotherapy-naïve mucosal melanomas (88%). Patients received toripalimab at 1 or 3 mg/kg via intravenous infusion every 2 weeks, in combination with axitinib 5 mg orally twice a day, in a dose-escalation and cohort-expansion study until confirmed disease progression, unacceptable toxicity, or voluntary withdrawal. The primary objective was safety. Secondary objectives included efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and tumor tissue biomarkers. RESULTS: Thirty-three patients were enrolled. No dose-limiting toxicities were observed. Ninety-seven percent of patients experienced treatment-related adverse events (TRAEs). The most common TRAEs were mild (grade 1 or 2) and included diarrhea, proteinuria, hand and foot syndrome, fatigue, AST or ALT elevation, hypertension, hypo- or hyperthyroidism, and rash. Grade 3 or greater TRAEs occurred in 39.4% of patients. By the cutoff date, among 29 patients with chemotherapy-naïve mucosal melanoma, 14 patients (48.3%; 95% CI, 29.4% to 67.5%) achieved objective response, and the median progression-free survival time was 7.5 months (95% CI, 3.7 months to not reached) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CONCLUSION: The combination of toripalimab plus axitinib was tolerable and showed promising antitumor activity in patients with treatment-naïve metastatic mucosal melanoma. Patients enrolled in this study were all Asian, and this combination therapy must be validated in a randomized phase III trial that includes a non-Asian population before it can become a standard of care.
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“Combination therapies such as sintilimab plus anlotinib, sintilimab plus IBI305 (bevacizumab biosimilar), camrelizumab plus apatinib, and toripalimab plus axitinib demonstrated potent antitumor effects in multiple types of cancers [22, 114–120].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [120]
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Metadata
- Authors
- Sheng, X., Yan, X., Chi, Z., Si, L., Cui, C., Tang, B., Li, S., Mao, L., Lian, B., Wang, X., Bai, X., Zhou, L., Kong, Y., Dai, J., Wang, K., Tang, X., Zhou, H., Wu, H., Feng, H., Yao, S., Flaherty, K. T., & Guo, J.
- Affiliations
- Peking University Cancer Hospital (CN)
- OrigiMed, Shanghai, People’s Republic of China
- Junshi Biosciences (China) (CN)
- Shanghai Junshi Biosciences, Shanghai, People’s Republic of China
- Massachusetts General Hospital (US)
- Corresponding author
- Guo, Jun
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2019-11-10
- Volume
- 37
- Issue
- 32
- Pages
- 2987-2999
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC6839911
- OpenAlex
- W2967113395
- Cited by
- 175
- References
- 40
- Citations by year
- 2026: 13 · 2025: 10 · 2024: 22 · 2023: 30 · 2022: 36 · 2021: 41 · 2020: 21 · 2019: 2
- FWCI
- 10.45
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Journal of Clinical Oncology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Greater South Information System
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
- Keywords
- axitinib, toripalimab, mucosal melanoma, metastatic melanoma, anti-PD-1 therapy, VEGF inhibition, combination immunotherapy, immune checkpoint inhibitors, treatment-related adverse events, objective response rate, progression-free survival, tumor microenvironment, immunogenicity, pharmacokinetics, pharmacodynamics, Asian patients, dose escalation, hand-foot syndrome, proteinuria
- MeSH terms
- Exome Sequencing, Axitinib, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Male, Melanoma, Middle Aged, Mucous Membrane, Vascular Endothelial Growth Factor A, Programmed Cell Death 1 Receptor, Antibodies, Monoclonal, Humanized
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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