Making a Case for Biomarkers in Cancer Immunotherapy

Immune response boosters in oncology, approved for melanoma so far, are being evaluated in several different cancer types. While the drugs perform well, there is a definite need to identify responsive patient cohorts.

At first glance, it’s hard to get excited about the preliminary results of an early phase trial study of pembrolizumab (Keytruda, MK-3475) in women with triple-negative breast cancer (TNBC). The non-randomized study has, so far, yielded an overall response rate of 18.5%—only 5 among 27 evaluable patients.

The findings drew attention at the San Antonio Breast Cancer Symposium, in part because TNBC is a notoriously hard-to-treat form of the disease. The work was presented by Rita Nanda, MD, of the University of Chicago, who led a multinational list of authors including academics and several Merck employees.

Keytruda is a monoclonal antibody given by infusion. When it binds PD-1, as it’s engineered to do with high affinity, it can unleash the body’s normal immune cells to fight a tumor. Recently, the FDA approved Keytruda for use in advanced melanoma. Last week, at the annual meeting of the American Society of Hematology, investigators reported preliminary findings that the drug is well-tolerated and may be helpful in Hodgkin’s lymphoma.

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