Supplement: Who Gets Immunotherapy for Cancer?

Managing Patient Expectations Requires Better Biomarkers and Companion Diagnostics

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Improving Cancer Immunotherapy Success Rates

A successful response to cancer immunotherapy is only partly a matter of immune cell dynamics within a tumor. If a tumor is to be reduced and cleared, cancer immunotherapy must also engage systemic immunity. For example, successful cancer immunotherapy can activate a population of peripheral memory immune cells. Cancer immunotherapy can also incorporate responses at the tumor site influenced by interactions between the gut microbiome and the immune system.
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IL-10 (AM0010) phase I trial offers novel mechanism for immune-oncology drugs in solid tumors

More commonly known as an inhibitory cytokine, high doses of interleukin 10 (IL-10) have been shown to lead to the activation and survival of antigen stimulated CD8 T cells. According to a study published in the Journal of Clinical Oncology, the investigators in this first-in-human, phase 1 clinical trial of IL-10 (AM0010), demonstrate antitumor activity and therapy tolerability in a pretreated population.  The primary endpoint of the study was to establish safety, tolerability and the maximum tolerated dose.  This goal appears to have been met, with a low incidence of adverse events, most of which were temporary or reversible.  The dose-escalation study was followed by a renal cell cancer dose-expansion cohort.
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Researchers in this immuno-oncology trial used Myriad RBM’s services to measure serum biomarkers.

Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma

The data presented in this paper shows baseline and on-treatment biomarkers from a phase 1b study of the PD-1 inhibitor nivolumab in renal cell carcinoma. The study examined immune changes in the microenvironment of the tumor, such as types of tumor infiltrating cells and gene expression and show that they correlate with gene expression and protein biomarkers in peripheral blood. The results suggest induction of a Th1 response locally and correlating T cell chemotactic proteins in the periphery, both of which were dose independent.

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Use of biomarkers to guide immunotherapy drug development

VentiRx, the developers of motolimod, a TLR8 agonist, have published preclinical and clinical results that indicate effective immune system stimulation in human whole blood cultures, non-human primates, healthy subjects, and late-stage cancer patients. Immune system stimulation in all of these settings is dose-dependent, characterized by similar biomarkers, and consistent with stimulation via the TLR8 pathway. The rapid translation and development of motolimod clearly benefited from the use of standardized immune monitoring systems and validated biomarker assays.

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Biomarker signatures predict clinical outcomes in metastatic colorectal cancer (mCRC) patients treated with chemotherapy and cediranib

Researchers sought to explore biomarkers in pre- and on- treatment mCRC patients receiving chemotherapy with and without cediranib, in order to identify patient subgroups who may benefit from the combination cediranib therapy. https://www.nature.com/bjc/journal/vaop/ncurrent/full/bjc2014436a.html
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