Regulatory considerations in the design, development and quality of monoclonal antibodies and related products for the diagnosis and treatment of cancer

Shapiro, Marjorie A.

doi:10.3389/fonc.2024.1379738

Cited by 5 publications

(1 citation statement)

References 162 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Notably, the emergence of bispecific antibodies has provided new insights into the resolution of immunotherapy resistance. By 2023, nine bispecific antibodies had been approved by the FDA [ 136 ]. Consequently, research is increasingly focused on developing bispecific antibodies.…”

Section: Combined Antitumor Immunotherapy Strategies For Tumor Resist...mentioning

confidence: 99%

Mechanisms, combination therapy, and biomarkers in cancer immunotherapy resistance

Yang,

Cui,

Sun

et al. 2024

Cell Commun Signal

View full text Add to dashboard Cite

Anti-programmed death 1/programmed death ligand 1 (anti-PD-1/PD-L1) antibodies exert significant antitumor effects by overcoming tumor cell immune evasion and reversing T-cell exhaustion. However, the emergence of drug resistance causes most patients to respond poorly to these immune checkpoint inhibitors (ICIs). Studies have shown that insufficient T-cell infiltration, lack of PD-1 expression, deficient interferon signaling, loss of tumor antigen presentation, and abnormal lipid metabolism are all considered to be closely associated with immunotherapy resistance. To address drug resistance in tumor immunotherapy, a lot of research has concentrated on developing combination therapy strategies. Currently, ICIs such as anti-PD-1 /PD-L1 antibody combined with chemotherapy and targeted therapy have been approved for clinical treatment. In this review, we analyze the mechanisms of resistance to anti-PD-1/PD-L1 therapy in terms of the tumor microenvironment, gut microbiota, epigenetic regulation, and co-inhibitory immune checkpoint receptors. We also discuss various promising combination therapeutic strategies to address resistance to anti-PD-1/PD-L1 drugs, including combining these therapies with traditional Chinese medicine, non-coding RNAs, targeted therapy, other ICIs, and personalized cancer vaccines. Moreover, we focus on biomarkers that predict resistance to anti-PD-1/PD-L1 therapy as well as combination therapy efficacy. Finally, we suggest ways to further expand the application of immunotherapy through personalized combination strategies using biomarker systems.

show abstract

Section: Combined Antitumor Immunotherapy Strategies For Tumor Resist...mentioning

confidence: 99%