4.6 Article

Exploring a new pathway for biomarker-based approval of immunotherapies

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Article Gastroenterology & Hepatology

Inflamed and non-inflamed classes of HCC: a revised immunogenomic classification

Carla Montironi et al.

Summary: This study characterizes the immunogenomic contexture of hepatocellular carcinoma (HCC) and defines inflamed and non-inflamed tumors. Two distinct patterns of CTNNB1 are associated with differential immune evasion and may help predict immune response in HCC.
Review Oncology

Immunotherapies for hepatocellular carcinoma

Josep M. Llovet et al.

Summary: Liver cancer, specifically hepatocellular carcinoma (HCC), is the second leading cause of cancer-related death globally. Traditional treatments involve specific drugs, but the emergence of immune checkpoint inhibitors has revolutionized the management of HCC.

NATURE REVIEWS CLINICAL ONCOLOGY (2022)

Article Oncology

An appraisal of FDA approvals for adult solid tumours in 2017-2021: has the eagle landed?

Nathan Cherny

Summary: This Perspective evaluates the FDA approvals of therapeutic agents for use in solid tumour oncology for the period 2017-2021 against the aspirations of the Cancer Moonshot. The results indicate a low level of clinical benefit for a substantial proportion of the new indications, highlighting the need for improvement in the quality of approved treatments.

NATURE REVIEWS CLINICAL ONCOLOGY (2022)

Article Biochemistry & Molecular Biology

Molecular correlates of clinical response and resistance to atezolizumab in combination with bevacizumab in advanced hepatocellular carcinoma

Andrew X. Zhu et al.

Summary: This study analyzed tumor samples from patients with hepatocellular carcinoma and found that combination therapy with atezolizumab and bevacizumab was effective in treating this type of cancer. Patients with high expression of VEGF Receptor 2, regulatory T cells, and myeloid inflammation signatures showed better outcomes with the combination therapy compared to atezolizumab alone. These findings provide insights into baseline immune and genetic features that can identify patients who will benefit from the combination therapy of atezolizumab and bevacizumab in advanced hepatocellular carcinoma.

NATURE MEDICINE (2022)

Letter Biochemistry & Molecular Biology

Accelerated approvals hit the target in precision oncology

Vivek Subbiah et al.

NATURE MEDICINE (2022)

Review Oncology

Molecular pathogenesis and systemic therapies for hepatocellular carcinoma

Josep M. Llovet et al.

Summary: In this article, Llovet and colleagues review recent advances in hepatocellular carcinoma therapy and discuss the clinical workflows for selecting and monitoring patients. The article covers the molecular pathogenesis of HCC, molecular classes and determinants of heterogeneity, and effective systemic therapies including immunotherapy. The authors propose a flowchart of sequential therapies, explore mechanisms of resistance, and address the need for predictive biomarkers.

NATURE CANCER (2022)

Article Biochemistry & Molecular Biology

Meta-analysis of tumor- and T cell-intrinsic mechanisms of sensitization to checkpoint inhibition

Kevin Litchfield et al.

Summary: Checkpoint inhibitors (CPIs) enhance adaptive immunity, with clonal tumor mutation burden (TMB) identified as the strongest predictor of CPI response. Dinucleotide variants may serve as a source of immunogenic epitopes, while copy-number alterations and HLA evolutionary divergence lack pan-cancer significance.
Article Oncology

Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

Anup K. Amatya et al.

Summary: Subgroup analyses in oncology trials are crucial for interpreting treatment effects based on patient characteristics, but using these results for regulatory decisions and product labeling can be challenging. The decision on which subgroups to include in labeling relies on the disease's pathophysiology, mechanistic justification, safety data, and external information.

CLINICAL CANCER RESEARCH (2021)

Article Oncology

The current landscape of the FDA approved companion diagnostics

Jan Trost Jorgensen

Summary: Predictive biomarkers play a key role in precision medicine, especially in the development of companion diagnostics for hematological and oncological drugs. The FDA has approved 44 CDx assays by the end of 2020, with diverse analytical platforms requiring rigorous regulatory pathways for approval.

TRANSLATIONAL ONCOLOGY (2021)