A randomized multicentered phase II study to evaluate SHR-1210 (PD-1 antibody) in subjects with advanced hepatocellular carcinoma (HCC) who failed or intolerable to prior systemic treatment

Qin, Shukui; Ren, Zhigang; Meng, Zhiqiang; Chen, Z.D.; Chai, Xiaoli; Xiong, Jianping; Bai, Yu; Yang, Lu; Zhu, Hailong; Fang, Weijia; Lin, Xinhua; Chen, X.M.; Li, E.X.; Xia, Yan; Zou, Jian

doi:10.1093/annonc/mdy424.029

Cited by 30 publications

(29 citation statements)

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“…A similar rate was also described in the Keynote-224 study of pembrolizumab [14]. These data have been also confirmed in the preliminary analysis of other Phases 1-2 trials investigating different agents, including durvalumab, camrelizumab, and atezolizumab [23][24][25][26]. The need for corticosteroids to treat immune related adverse events has been relatively low (maximum 6%) so far [26].…”

Section: Immune-related Adverse Events and Overall Safety Of Immune Csupporting

confidence: 67%

“…Across dose escalation and expansion phases (262 patients), grade 3/4 treatment-related adverse events occurred in 20%. The ORR was 20% (95% CI: [15][16][17][18][19][20][21][22][23][24][25][26] in 214 patients treated in the dose expansion phase with a median duration of response of 9.9 months and a disease control rate of 64% (95% CI: 58-71).…”

Section: Concluded Trialsmentioning

confidence: 99%

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Immunotherapy for hepatocellular carcinoma: A review of potential new drugs based on ongoing clinical studies as of 2019

Tovoli

Casadei-Gardini

Benevento

et al. 2019

Digestive and Liver Disease

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In the latest years, antineoplastic immunotherapy revolutionised the therapeutic landscape in oncology. First shown to be effective in melanoma and non-small cell lung carcinoma, immune checkpoint inhibitors are now being tested for the treatment of hepatocellular carcinoma (HCC). Preliminary results have been particularly promising. As a consequence, an increasing number of clinical trials are underway. The role of the immune system in carcinogenesis (with particular reference to tumour escape immune mechanisms), as well as the current immunotherapy trials for HCC in its different clinical scenarios, are the subject of this review. In particular, we aim to provide fresh updates about these novel therapeutic agents which promise to shape the future therapeutic scenario of HCC.

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Section: Immune-related Adverse Events and Overall Safety Of Immune Csupporting

confidence: 67%

Section: Concluded Trialsmentioning

confidence: 99%

Immunotherapy for hepatocellular carcinoma: A review of potential new drugs based on ongoing clinical studies as of 2019

Tovoli

Casadei-Gardini

Benevento

et al. 2019

Digestive and Liver Disease

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“…Other PD-1 inhibitors with less mature clinical data in HCC include tislelizumab (BGB-A317) [111], camrelizumab (SHR-1210) [112] and cemiplimab (REGN2810) [113]. Data around their safety and preliminary efficacy are available mostly from dose-expansion cohorts of earlyphase clinical studies and confirm incidence and intensity of treatment-related AEs that are in keeping with the mechanism of action of the compounds.…”

Section: Pd-1/pd-l1 Monotherapymentioning

confidence: 99%

Immune-based therapies for hepatocellular carcinoma

et al. 2020

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Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related death. The immune-rich contexture of the HCC microenvironment makes this tumour an appealing target for immune-based therapies. Here, we discuss how the functional characteristics of the liver microenvironment can potentially be harnessed for the treatment of HCC. We will review the evidence supporting a therapeutic role for vaccines, cell-based therapies and immune-checkpoint inhibitors and discuss the potential for patient stratification in an attempt to overcome the series of failures that has characterised drug development in this disease area.

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“…Currently, several clinical studies are ongoing with Camrelizumab in HCC either alone or in combination with other treatments [40] . A phase II/III trial of Camrelibzumab reported a response rate of 13.8% and 6 month overall survival rate of 74.7% in HCC patients previously treated with systemic treatment (NCT02989922) [44] .…”

Section: Camrelizumabmentioning

confidence: 99%

Immune checkpoint blockade therapies for HCC: current status and future implications

Shrestha¹,

Bridle²,

Crawford³

et al. 2019

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Hepatocellular carcinoma (HCC) is the most lethal and common type of liver cancer with limited treatment options at the advanced stage. The use of immune checkpoint inhibitor (ICI) based immunotherapy is exponentially increasing in the treatment of patients with advanced solid tumors. The expression of immune checkpoints on tumor cells leading to lower activity of T-cells is one of the major mechanisms of immune escape. Checkpoint blockade immunotherapies with antibodies against PD-1, PD-L1 or CTLA-4 are being investigated in clinical trials in HCC patients. ICIs have improved survival in patients with inoperable advanced stage HCC where other curative treatments are not applicable. However, the response rates remain low with only a small subset of patients responding to this therapy. There is an unmet need to identify predictive markers to select those HCC patients who would benefit from ICI therapies. Importantly, epithelial-to-mesenchymal transition (EMT), a major process driving HCC invasion and metastasis by regulating the phenotypic cellular switching from epithelial to mesenchymal state, has been implicated as a resistance mechanism associated with ICI therapies. The role of EMT as a regulator of immune checkpoint molecule in HCC is just emerging. However, the consequence of EMT as a resistance mechanism in HCC patients undergoing ICI treatments remains unexplored. In this review, we summarize the recent clinical studies with ICIs in HCC and highlight the trials underway featuring novel monotherapies and combinatorial approaches based on immune and non-immune therapies. We will discuss the ongoing efforts to discover new immune checkpoint molecules in HCC as potential drug targets. We also highlight the role of EMT in facilitating therapy resistance in HCC treated with ICIs and discuss potential strategies to circumvent resistance in ICI treated HCC patients.

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A randomized multicentered phase II study to evaluate SHR-1210 (PD-1 antibody) in subjects with advanced hepatocellular carcinoma (HCC) who failed or intolerable to prior systemic treatment

Cited by 30 publications

References 0 publications

Immunotherapy for hepatocellular carcinoma: A review of potential new drugs based on ongoing clinical studies as of 2019

Immunotherapy for hepatocellular carcinoma: A review of potential new drugs based on ongoing clinical studies as of 2019

Immune-based therapies for hepatocellular carcinoma

Immune checkpoint blockade therapies for HCC: current status and future implications

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