Abstract

An Immunotherapy Ahead Of Its Molecular Biomarkers?

Shian-Jiun Shih, Partner, Kiang Consulting Services, LLC

In recent years, new drugs have expanded the treatment options available to cancer patients, especially in the field of immunotherapy. However, cancer drug development processes remain expensive and inefficient. Now more than ever, giving the right treatment to the right patients at the right time is crucial to ensuring the best clinical outcomes. This adds another layer of complexity towards successful drug development. Diverse and vast data can be generated by various “–omics”, but the challenge is efficient identification of useful biomarkers to expedite drug development without exhausting limited resources. The allogeneic granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting whole-cell cancer vaccine (GVAX) provides a case study for the costly pitfall of advancing without effective biomarker strategies. This immunotherapy product has been in development for nearly two decades; it demonstrated impressive clinical benefits for several cancers in many early phase clinical trials, but failed to reproduce them in larger studies. Molecular biomarker research performed on patient samples from GVAX clinical trials began to provide deeper insight into its mechanism of action and the biology underlining the responses observed in subsets of patients. GVAX in combination with other immunotherapeutics are currently evaluated in several clinical studies. Armed with modern biomarker plans in selecting patients and/or monitoring responses, after twenty-years, the promising results of GVAX immunotherapy may be clinically validated.