Ipilimumab for Advanced Melanoma in an Expanded Access Programme (EAP): Ocular, Mucosal and Acral Subtype UK Experience

Shaw, Heather; Larkin, James; Corrie, Pippa; Ellis, Sebastien; Nobes, Jenny; Marshall, Ernest; Kumar, Satish; Danson, Sarah; Plummer, Ruth; Nathan, Paul

doi:10.1016/s0923-7534(20)33704-2

Cited by 9 publications

(6 citation statements)

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“…The median OS was 9.6 months (95% confidence interval [CI] 1.6–11.1) and the one-year OS rate was 14%. Evidence of the antitumor activity of ipilimumab in patients with MM was also observed in three expanded access program and one named patient program studies in Italy, 19 South Africa, 20 the UK, 21 and Australia. 22 Patients with unresectable stage III or IV disease were treated with ipilimumab at a dose of 3 mg/kg every 3 weeks for up to four cycles, and the ORR ranged from 0% to 12%.…”

Section: Resultsmentioning

confidence: 71%

“…Patients received up to four cycles of ipilimumab that were administered at a dose of 3 mg/kg at 3-week intervals. None achieved a CR and the ORR of seven 19 South Africa, 20 the UK, 21 and Australia. 22 Patients with unresectable stage III or IV disease were treated with ipilimumab at a dose of 3 mg/kg every 3 weeks for up to four cycles, and the ORR ranged from 0% to 12%.…”

Section: Anti-ctla-4 Monoclonal Antibodiesmentioning

confidence: 95%

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Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

Kan

Zhao

et al. 2020

Ther Adv Med Oncol

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Background: Conventional cytotoxic chemotherapy offers minor benefit to patients with mucosal melanoma (MM). Although immune checkpoint inhibitors (ICIs) have become the preferred approach in patients with advanced or metastatic cutaneous melanoma, the evidence of their clinical use for MM is still limited. This systematic review aims to summarize the efficacy and safety of ICIs in advanced or metastatic MM. Methods: We searched electronic databases, conference abstracts, clinical trial registers and reference lists for relevant studies. The primary outcomes included the overall response rate (ORR), median progression-free survival (PFS), median overall survival (OS), one-year PFS rate, and one-year OS rate. Results: This review identified 13 studies assessing anti-CTLA-4 monotherapy, 22 studies assessing anti-PD-1 monotherapy, two studies assessing anti-CTLA-4 and anti-PD-1 combination therapy, one study assessing anti-PD-1 antibodies combined with axitinib, and three studies assessing anti-PD-1 antibodies combined with radiotherapy. For most patients who received ipilimumab monotherapy, the ORR ranged from 0% to 17%, the median PFS was less than 5 months, and the median OS was less than 10 months. For patients who received nivolumab or pembrolizumab monotherapy, most studies showed an ORR of more than 15% and a median OS of more than 11 months. The combined administration of anti-CTLA-4 and anti-PD-1 agents showed benefits over single-agent therapy with an ORR of more than 33.3%. In a phase Ib trial of toripalimab in combination with axitinib, approximately half of patients had complete or partial responses. Three retrospective studies that investigated anti-PD-1 antibodies combined with radiotherapy showed an ORR of more than 50%, which was higher than each single modality treatment. Conclusions: Immune checkpoint inhibitors, especially anti-PD-1 monoclonal antibodies alone and in combination with anti-CTLA-4 monoclonal antibodies or other modalities, are promising treatment options for advanced or metastatic MM. However, high-level evidence is still needed to support the clinical application.

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Section: Resultsmentioning

confidence: 71%

Section: Anti-ctla-4 Monoclonal Antibodiesmentioning

confidence: 95%

Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

Kan

Zhao

et al. 2020

Ther Adv Med Oncol

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“…Five additional prospective studies with 185 patients in total investigated ipilimumab at a dose of 3 mg/kg body weight [105][106][107][108][109]. In the study published by Jung et al [109], 10 UM patients (total n = 106 melanoma patients) were treated.…”

Section: Ipilimumabmentioning

confidence: 99%

The Role of Immune Checkpoint Blockade in Uveal Melanoma

Wessely

Steeb

Erdmann

et al. 2020

IJMS

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Uveal melanoma (UM) represents the most common intraocular malignancy in adults and accounts for about 5% of all melanomas. Primary disease can be effectively controlled by several local therapy options, but UM has a high potential for metastatic spread, especially to the liver. Despite its clinical and genetic heterogeneity, therapy of metastatic UM has largely been adopted from cutaneous melanoma (CM) with discouraging results until now. The introduction of antibodies targeting CTLA-4 and PD-1 for immune checkpoint blockade (ICB) has revolutionized the field of cancer therapy and has achieved pioneering results in metastatic CM. Thus, expectations were high that patients with metastatic UM would also benefit from these new therapy options. This review provides a comprehensive and up-to-date overview on the role of ICB in UM. We give a summary of UM biology, its clinical features, and how it differs from CM. The results of several studies that have been investigating ICB in metastatic UM are presented. We discuss possible reasons for the lack of efficacy of ICB in UM compared to CM, highlight the pitfalls of ICB in this cancer entity, and explain why other immune-modulating therapies could still be an option for future UM therapies.

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“…In the results of a published expanded access program, five patients with unresectable stage III/IV AM received 3 mg/kg ipilimumab for up to four cycles. None of them was untreated, and two (40%) patients had a PR ( 12 ). A retrospective review of 35 AM patients receiving ipilimumab either 3 mg/kg or 10 mg/kg was conducted in America.…”

Section: Resultsmentioning

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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Ipilimumab for Advanced Melanoma in an Expanded Access Programme (EAP): Ocular, Mucosal and Acral Subtype UK Experience

Cited by 9 publications

References 0 publications

Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

The Role of Immune Checkpoint Blockade in Uveal Melanoma

Immune Checkpoint Inhibitors in Advanced Acral Melanoma: A Systematic Review

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