The field of immuno-oncology (IO) is rapidly expanding, generating enormous interest on
the part of drug developers and giving new hope to patients and physicians. Attempts to harness the
immune system to fight cancer date back to the 19th century; however, it is only in recent years that
immunotherapies have entered mainstream oncology and have shown promise across a broad range
of tumor types. New therapeutic combinations are emerging, with companies pairing two immunotherapies,
an immunotherapy and a molecularly targeted therapy, or an immunotherapy plus traditional
chemotherapy in order to more effectively fight cancer. Some immunotherapies are also pairing
with companion diagnostics in order to maximize efficacy in patient populations. All of these developments
come with their own unique challenges that drug developers will need to confront. This Perspective article reviews
developments in the IO field and highlights key challenges in successfully commercializing an IO therapy.
Keywords: Commercialization, companion diagnostics, immuno-oncology, oncology, precision medicine.
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