Next Article in Journal
Serum Concentrations of KL-6 in Patients with IPF and Lung Cancer and Serial Measurements of KL-6 in IPF Patients Treated with Antifibrotic Therapy
Next Article in Special Issue
Random Forest Modelling of High-Dimensional Mixed-Type Data for Breast Cancer Classification
Previous Article in Journal
Why Target Innate Immune Cells in Cancers?
Previous Article in Special Issue
Boosted EfficientNet: Detection of Lymph Node Metastases in Breast Cancer Using Convolutional Neural Networks

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
Cancers 2021, 13(4), 691;
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.
The rapidly evolving landscape of immuno-oncology (IO) is redefining the treatment of a number of cancer types. IO treatments are becoming increasingly complex, with different types of drugs emerging beyond checkpoint inhibitors. However, many of the new drugs either do not progress from phase I-II clinical trials or even fail in late-phase trials. We have identified at least five areas in the development of promising IO treatments that should be redefined for more efficient designs and accelerated approvals. Here we review those critical aspects of IO drug development that could be optimized for more successful outcome rates in all cancer types. It is important to focus our efforts on the mechanisms of action, types of response and adverse events of these novel agents. The use of appropriate clinical trial designs with robust biomarkers of response and surrogate endpoints will undoubtedly facilitate the development and subsequent approval of these drugs. Further research is also needed to establish biomarker-driven strategies to select which patients may benefit from immunotherapy and identify potential mechanisms of resistance. View Full-Text
Keywords: immuno-oncology; cancer; trial design; endpoints; biomarkers immuno-oncology; cancer; trial design; endpoints; biomarkers
Show Figures

Figure 1

MDPI and ACS Style

Bergamino Sirvén, M.; Pernas, S.; Cheang, M.C.U. Lights and Shadows in Immuno-Oncology Drug Development. Cancers 2021, 13, 691.

AMA Style

Bergamino Sirvén M, Pernas S, Cheang MCU. Lights and Shadows in Immuno-Oncology Drug Development. Cancers. 2021; 13(4):691.

Chicago/Turabian Style

Bergamino Sirvén, Milana, Sonia Pernas, and Maggie C.U. Cheang. 2021. "Lights and Shadows in Immuno-Oncology Drug Development" Cancers 13, no. 4: 691.

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

Back to TopTop