Immunotherapy has revolutionised oncology and represents a fast-growing area of new drug products in anti-cancer therapy. Patients can now benefit from an expanded landscape of treatment options for several tumour types. The value of cancer immunotherapy is well-established thanks to the clinical success following regulatory approval of several immunomodulators and cellular immunotherapies, and both the private and the public sector are investing to provide patients with improved immune-based agents and to extend the indications of already marketed products. Although recent achievements offer the best promise for successful treatment, innovators in the field of cancer immunotherapy still face many challenges toward commercialisation that could be mitigated by a smart drug development strategy.
Keywords: Biomarker; CAR-T cells; Clinical development; Immunotherapy; Industry; Intellectual property; Monoclonal antibody; New indications; Patient-centric approach; Resistance to treatment; Tumour heterogeneity.