Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial

Tang, Bixia; Chen, Zhihong; Chen, Yingbo; Liu, Xiufeng; Wu, Di; Chen, Jing; Song, Xin; Wang, Weifeng; Dong, Lei; Song, Haifeng; Wu, Hai; Feng, Hui; Yao, Sheng; Qin, Shuikui; Zhang, Xiaoshi; Guo, Jun

doi:10.1158/1078-0432.ccr-19-3922

Cited by 127 publications

(144 citation statements)

References 25 publications

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“…14 More recently, it has been reported across a series of predominantly retrospective studies that the ORR achieved with anti-PD-1 was 14.0-16.6% and the median overall survival (OS) was 18.2-25.8 months in AM patients, and 0-23.2% and 11.5-20.2 months for MM patients, respectively. [15][16][17][18][19][20] In contrast, in the Checkmate067 trial the ORR for nivolumab was 43.7% for all melanoma subtypes, with median PFS 6.9 months and median OS 36.9 months for CM patients. 21 Data thus far suggest that the AM and MM subtypes do not respond as robustly to anti-PD-1 therapy as CM.…”

Section: Introductionmentioning

confidence: 99%

The efficacy of anti‐programmed cell death protein 1 therapy among patients with metastatic acral and metastatic mucosal melanoma

et al. 2021

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Section: Introductionmentioning

confidence: 99%

The efficacy of anti‐programmed cell death protein 1 therapy among patients with metastatic acral and metastatic mucosal melanoma

et al. 2021

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“…The median OS was 16.9 months (95% CI, 10.9-not estimable months), and the median PFS was 3.2 months (95% CI, 1.8-3.6 months). The 1year OS rate was 56%, and the 1-year PFS rate was 10% (22).…”

Section: Anti-pd-1 Immunotherapymentioning

confidence: 95%

“…JS001, also known as toripalimab, was independently assessed in two studies, both of which were conducted in China (21,22). One was a single-center, phase 1, open-label, 2-part (part A doseescalation and part B dose-expansion) study.…”

Section: Anti-pd-1 Immunotherapymentioning

confidence: 99%

Immune Checkpoint Inhibitors in Advanced Acral Melanoma: A Systematic Review

Zheng

Zhang

et al. 2020

Front. Oncol.

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IntroductionAcral melanoma (AM) has different biological characteristics from cutaneous melanoma. Although systemic therapeutic strategies for advanced AM resemble those for advanced cutaneous melanoma, the evidence of the clinical use of immune checkpoint inhibitors (ICIs) for AM is still inadequate. We aimed to systematically analyze the therapeutic effects and safety profile of ICI treatments in advanced AM.MethodsThis systematic review was conducted in line with a previously registered protocol. Three electronic databases, conference abstracts, clinical trial registers, and reference lists of included articles were searched for eligible studies. The primary outcomes were therapeutic effects, and the secondary outcomes were the safety profiles.ResultsThis systematic review included six studies investigating anti-CTLA-4 immunotherapy, 12 studies investigating anti-PD-1 immunotherapy, one study investigating the combination therapy of anti-CTLA-4 and anti-PD-1, and one study investigating anti-PD-1 immunotherapy in combination with radiotherapy. In most studies investigating ipilimumab, the anti-CTLA-4 antibody, the objective response rate ranged from 11.4 to 25%, the median progression-free survival ranged from 2.1 to 6.7 months, and the median overall survival was more than 7.16 months. For studies discussing anti-PD-1 immunotherapy with nivolumab, pembrolizumab, or JS001, the objective response rate ranged from 14 to 42.9%, the median progression-free survival ranged from 3.2 to 9.2 months, and the median overall survival was more than 14 months. The combination therapy of anti-CTLA-4 and anti-PD-1 immunotherapy showed better efficacy with an objective response rate of 42.9% than single-agent therapy. The retrospective study investigating the combination therapy of anti-PD-1 immunotherapy and radiation showed no overall response. Few outcomes regarding safety were reported in the included studies.ConclusionsICIs, especially anti-CTLA-4 monoclonal antibodies combined with anti-PD-1 antibodies, are effective systematic treatments in advanced AM. However, there remains a lack of high-level evidence to verify their efficacy and safety and support their clinical application.

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“…In December 2018, based on positive efficacy results of a phase 2 trial and safety data from several clinical studies, toripalimab received approval in China for the second-line treatment of unresectable or metastatic melanoma [ 41 ]. One well-known study is the POLARIS-01 study [ 42 ]. It was a phase 2, single-armed multi-center trial, which was designed to evaluate safety and efficacy of toripalimab in Chinese patients with advanced melanoma who had failed in previous systemic treatments.…”

Section: Therapeutic Optionsmentioning

confidence: 99%

“…AEs were roughly the same for all types of cancer with the only outlier being fatal acute hepatitis in a patient with HCC with rapidly progressing disease [ 35 ]. When comparing these AEs to patients treated for advanced melanoma, toxicity profiles were about the same, occurring in ±20% of patients treated with toripalimab [ 42 ].…”

Section: Toxicitymentioning

confidence: 99%

Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: An Overview

2020

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Patients with hepatocellular carcinoma (HCC) face a common type of cancer, which is amongst the most deadly types of cancer worldwide. The therapeutic options range from curative resection or ablation to loco regional therapies in palliative setting and last but not least, systemic treatment. The latter group underwent major changes in the last decade and a half. Since the introduction of sorafenib in 2007, many other systemic treatments have been investigated. Most without success. It took more than ten years before lenvatinib could be added as alternative first-line treatment option. Just recently a new form of systemic treatment, immunotherapy, entered the field of therapeutic options in patients with HCC. Immune checkpoint inhibitors are becoming the new standard of care in patients with HCC. Several reviews reported on the latest phase 1/2 studies and discussed the higher response rates and better tolerability when compared to current standard of care therapies. This review will focus on elaborating the working mechanism of these checkpoint inhibitors, give an elaborate update of the therapeutic agents that are currently available or under research, and will give an overview of the latest trials, as well as ongoing and upcoming trials.

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Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial

Cited by 127 publications

References 25 publications

The efficacy of anti‐programmed cell death protein 1 therapy among patients with metastatic acral and metastatic mucosal melanoma

The efficacy of anti‐programmed cell death protein 1 therapy among patients with metastatic acral and metastatic mucosal melanoma

Immune Checkpoint Inhibitors in Advanced Acral Melanoma: A Systematic Review

Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: An Overview

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