Lights and Shadows in Immuno-Oncology Drug Development
Clinical Studies and Clinical Trials and Statistics Unit, The Institute of Cancer Research, London SM2 5NG, UK
Department of Medical Oncology, Catalan Institute of Oncology—ICO, L’Hospitalet de Llobregat, 08908 Barcelona, Spain
Breast Cancer Group, Institut d’Investigacio Biomedica de Bellvitge—IDIBELL, L’Hospitalet de Llobregat, 08908 Barcelona, Spain
Authors to whom correspondence should be addressed.
Academic Editor: David Wong
Received: 30 December 2020
Revised: 4 February 2021
Accepted: 5 February 2021
Published: 9 February 2021
The introduction of immunotherapy has had a significant impact on the cancer treatment landscape, with unprecedented survival outcomes in some tumor types. However, clinical development of immune-oncology (IO) agents presents both opportunities and challenges, and not all patients benefit to the same extent. Many factors influence trial designs and could potentially threaten the success of promising IO drugs: 1. Most IO trials still rely on response evaluation criteria based on image assessment only, while new approaches including biomarkers tracking response should be incorporated. 2. Surrogate endpoints for efficacy are still inferred from classical anticancer drugs that have not been specifically validated for IO trials. 3. There is a need for biomarker-driven clinical studies in order to select appropriated patients. 4. Long-term toxicity monitoring is needed, and dosage calculation should not rely on dose-dependent toxicities. 5. Optimizing the design of new IO agents with collaborative approaches assessing multiple drugs on a biomarker-based basis is needed.