CA209-9DX: phase III, randomized, double-blind study of adjuvant nivolumab vs placebo for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after curative resection or ablation

Exposito, M.J. Jimenez; Akce, Mehmet; Álvarez, Jorge Lima; Assenat, Éric; Balart, Louis; Baron, Aurore; Decaens, Thomas; Heurgué–Berlot, Alexandra; Martin, A.; Paik, S.W.; Poulart, Valerie; Sehbai, Aasim; Takemura, Nobuyuki; Yoon, Jung‐Hwan

doi:10.1093/annonc/mdy282.166

Cited by 15 publications

(9 citation statements)

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“…Nivolumab, an anti-PD-1 monoclonal antibody (mAb), is being assessed in a phase III, multicenter, randomized, double-blind CheckMate 9DX trial (NCT03383458). The study has an estimated enrollment of 530 HCC patients who will randomly receive either nivolumab (arm A) or placebo (arm B) ( 53 ).…”

Section: Immune Checkpoint Inhibitors In Localized Hccmentioning

confidence: 99%

Immune Checkpoint Inhibitors in the Treatment of HCC

et al. 2021

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Hepatocellular carcinoma (HCC) is the typical inflammation-induced neoplasia. It often prospers where a chronic liver disease persists, thus leading a strong rationale for immune therapy. Several immune-based treatments, including immune checkpoint inhibitors (ICI), cytokines, adoptive cell transfer, and vaccines, have been tested in the treatment of HCC. In this review, we summarize the role of the ICI in HCC patients in various sets of treatment. As for advanced HCC, the anti-Programmed cell Death protein 1 (PD1) antibodies and the anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) antibodies have been examined in patients with enthusiastic results in phase I-II-III studies. Overall, this led the Food and Drug Administration (FDA) to approve pembrolizumab, nivolumab, and nivolumab + ipilimumab in the second-line setting. The anti- Programmed Death-Ligand 1 (PDL-1) antibodies have also been evaluated. Thanks to the results obtained from phase III IMbrave study, atezolizumab + bevacizumab is now the standard of care in the first-line advanced setting of HCC. As for localized HCC, the putative immunological effect of locoregional therapies led to evaluate the combination strategy with ICI. This way, chemoembolization, ablation with radiofrequency, and radioembolization combined with ICI are currently under study. Likewise, the study of adjuvant immunotherapy following surgical resection is underway. In addition, the different ICI has been studied in combination with other ICI as well as with multikinase inhibitors and anti-angiogenesis monoclonal antibody. The evidence available suggests that combining systemic therapies and locoregional treatments with ICI may represent an effective strategy in this context.

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Section: Immune Checkpoint Inhibitors In Localized Hccmentioning

confidence: 99%

Immune Checkpoint Inhibitors in the Treatment of HCC

et al. 2021

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“…This strategy is being tested in several phase III studies. [74][75][76][77][78][79] In patients with intermediate HCC who are expected to obtain borderline benefits from locoregional therapy, such as patients with a single large tumor or multiple diffuse tumors, systemic treatment may have greater efficacy than locoregional treatment. 80 For patients with initial advanced disease that is later down-staged through immunotherapy, the integration of locoregional therapy may lead to long-term disease control.…”

Section: Ici-antiangiogenic Therapy Combinationmentioning

confidence: 99%

Evolution of systemic treatment for advanced hepatocellular carcinoma

Shen

Cheng

2021

The Kaohsiung J of Med Scie

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Advanced hepatocellular carcinoma (HCC) was considered an inherently refractory tumor in the chemotherapy era . However, systemic therapy has evolved to molecular targeted therapy and immunotherapy, and nine treatment regimens have been approved worldwide during the past 20 years. The approved regimens target tumor angiogenesis or tumor immunity, the two cancer hallmarks.Recently, the combination of atezolizumab (antiprogrammed cell death ligand 1) and bevacizumab (anti-vascular endothelial growth factor) has improved the efficacy of systemic therapy in treating advanced HCC without excessive toxicities or deterioration of quality of life. This review summarizes the major advances in systemic therapy and provides future perspectives on the next-generation systemic therapy for advanced HCC.

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“…Since combination therapy with immune checkpoint inhibitors has shown promising results in palliative treatment with combination of atezolizumab and bevacizumab being approved by FDA and EMA, several large RCTs are exploring the application of immunotherapy in adjuvant setting after ablation. A trial of Nivolumab, a PD1 inhibitor has recently finished recruiting [58], and trials of pembrolizumab (anti-PD1), durvalumab + bevacizumab, and atezolizumab + bevacizumab (both anti-PD-L1 + anti-VEGF) are still recruiting [59][60][61]. Results are eagerly awaited by 2023-24.…”

Section: Image-guided Tumor Ablationmentioning

confidence: 99%

Advances in Diagnostic and Interventional Radiology in Hepatocellular Carcinoma

Öcal

Rössler

Ricke

et al. 2021

Dig Dis

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Background: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related deaths, and radiological imaging and locoregional therapies are essential for the management of patients with HCC. Summary: In cirrhotic patients, a characteristic imaging pattern establishes the noninvasive diagnosis of HCC with acceptable sensitivity and high specificity. In addition to diagnosis, imaging is used in the staging of patients and treatment allocation. Multiparametric MRI with hepatospecific contrast agents improves lesion detection, characterization, and treatment allocation; recently described imaging criteria allow identification of precursor lesions. Radiofrequency ablation (RFA) and transarterial chemoembolization (TACE) have been established in the treatment of patients with HCC at the early and intermediate stages, respectively. Microwave ablation has been described as an alternative to RFA in selected cases. Imaging-guided brachytherapy, a catheter-based radiotherapy technique, offers advantages to overcome some limitations of the aforementioned therapies, including the tumor location and size. Currently, no adjuvant therapy is recommended after RFA or TACE, but several new drugs are under evaluation. Furthermore, although the exact role of selective internal radiation therapy (SIRT) in HCC still needs to be defined, it is an alternative to systemic agents in patients with intolerance, and additional benefit has been shown in selected subgroups. Additionally, SIRT offers an alternate to TACE with higher objective response rates in patients who needs bridging before transplantation. Key Messages: New imaging criteria improved lesion detection in patients at a risk for HCC, and advances in interventional therapies expanded the range of patients eligible for locoregional treatments.

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CA209-9DX: phase III, randomized, double-blind study of adjuvant nivolumab vs placebo for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after curative resection or ablation

Cited by 15 publications

References 0 publications

Immune Checkpoint Inhibitors in the Treatment of HCC

Immune Checkpoint Inhibitors in the Treatment of HCC

Evolution of systemic treatment for advanced hepatocellular carcinoma

Advances in Diagnostic and Interventional Radiology in Hepatocellular Carcinoma

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