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Cancers
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Clinical Development of Drugs and Drug Combinations Modulating Immune Checkpoints...
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Clinical Development of Drugs and Drug Combinations Modulating Immune Checkpoints in Cancer Therapy

A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Cancer Therapy".

Deadline for manuscript submissions: closed (30 September 2023) | Viewed by 4205

Special Issue Editor

Dr. Andrea Antonuzzo

E-Mail Website
Guest Editor
Unit of Medical Oncology 1, Azienda Ospedaliero-Universitaria Pisana, Santa Chiara Hospital, 56126 Pisa, Italy
Interests: treatment of solid tumors (urological; lung; breast; colorectal; melanoma and rare cancers); supportive care; toxicities observed with different anticancer therapies

Special Issue Information

Dear Colleagues,

In recent years, the established role of immunotherapy as first-line treatment has improved prognosis for different cancers. Except for long-term responders, many patients may develop acquired resistance to immune checkpoint inhibitors (ICIs) causing relapses and progressive disease.

Today, strategies combining immune checkpoint inhibitors (ICIs) with methods of optimizing antigen presentation, (Chemotherapy, other ICIs, mABs, co-stimulatory pathway agonists, modified cytokines, metabolic pathway modulators, cell therapies, and therapeutic vaccines) are under evaluation and, in some cases, available into clinical practice for overcoming this crucial point.

Chemotherapy can act as a priming therapy to increase a tumor's response to immunotherapy and together they also prolong overall survival. Other approaches, including combinations of PD-1/PD-L1 antibodies and anti-VEGF agents significantly improved clinical outcomes compared with respective standards of care, for example in patients with non-small-cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC).  Additionally, the combination of different ICIs and ICIs with targeted agents are recently approved. In addition to these promising results we have to consider the development of new toxicities that may cause treatment delays or sometimes definitive discontinuation. The “new era” of ICIs and all their combination with other drugs, led to an important growth of these clinical scenarios, so that clinicians have to know many innovative and combined immunotherapies.

Immune checkpoint inhibitors (ICI) are a milestone in the treatment of many solid and hematological cancers despite a relevant part of patients do not have a clinical benefit and others develop primary resistance or progressive diseases.

Developing new combinations with other drugs is a real attempt to overcome this issue and, at the same time, warrant the need to maintain an adequate balance with the growth of immune related adverse events. The topic of toxicity should be the limit for many promising combination treatments and need to be further evaluated.

This Special Issue may try to give to clinical community the opportunity to discuss these themes and to better understand all the innovation in the field of cancer immunotherapy.

This Special Issue aims to better describe new combinations of ICIs with other drugs to enhance efficacy and activity in cancer care. In this Special Issue, original research articles and reviews are welcome. Research areas may include (but are not limited to) the following:

-New combination of ICIs;

-Clinical development of new drugs combination.

 I look forward to receiving your contributions.

Dr. Andrea Antonuzzo
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Cancers is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • Immuno checkpoint inhibitors (ICIs)
  • immunotherapy
  • CTLA-4
  • PD-1
  • PD-L1
  • Combination strategy
  • Immunomodulation
  • immune related adverse events
  • Emerging toxicities
  • ICIs resistance

Published Papers (2 papers)

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Review

20 pages, 918 KiB  
Review
Trial Design for Cancer Immunotherapy: A Methodological Toolkit
by Everardo D. Saad, Elisabeth Coart, Vaiva Deltuvaite-Thomas, Leandro Garcia-Barrado, Tomasz Burzykowski and Marc Buyse
Cancers 2023, 15(18), 4669; https://doi.org/10.3390/cancers15184669 - 21 Sep 2023
Viewed by 1325
Abstract
Immunotherapy with checkpoint inhibitors (CPIs) and cell-based products has revolutionized the treatment of various solid tumors and hematologic malignancies. These agents have shown unprecedented response rates and long-term benefits in various settings. These clinical advances have also pointed to the need for new [...] Read more.
Immunotherapy with checkpoint inhibitors (CPIs) and cell-based products has revolutionized the treatment of various solid tumors and hematologic malignancies. These agents have shown unprecedented response rates and long-term benefits in various settings. These clinical advances have also pointed to the need for new or adapted approaches to trial design and assessment of efficacy and safety, both in the early and late phases of drug development. Some of the conventional statistical methods and endpoints used in other areas of oncology appear to be less appropriate in immuno-oncology. Conversely, other methods and endpoints have emerged as alternatives. In this article, we discuss issues related to trial design in the early and late phases of drug development in immuno-oncology, with a focus on CPIs. For early trials, we review the most salient issues related to dose escalation, use and limitations of tumor response and progression criteria for immunotherapy, the role of duration of response as an endpoint in and of itself, and the need to conduct randomized trials as early as possible in the development of new therapies. For late phases, we discuss the choice of primary endpoints for randomized trials, review the current status of surrogate endpoints, and discuss specific statistical issues related to immunotherapy, including non-proportional hazards in the assessment of time-to-event endpoints, alternatives to the Cox model in these settings, and the method of generalized pairwise comparisons, which can provide a patient-centric assessment of clinical benefit and be used to design randomized trials. Full article
(This article belongs to the Special Issue Clinical Development of Drugs and Drug Combinations Modulating Immune Checkpoints in Cancer Therapy)
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13 pages, 289 KiB  
Review
Immune Checkpoint Inhibitor Rechallenge in Renal Cell Carcinoma: Current Evidence and Future Directions
by Enrico Sammarco, Fiorella Manfredi, Amedeo Nuzzo, Marco Ferrari, Adele Bonato, Alessia Salfi, Debora Serafin, Luca Zatteri, Andrea Antonuzzo and Luca Galli
Cancers 2023, 15(12), 3172; https://doi.org/10.3390/cancers15123172 - 13 Jun 2023
Cited by 2 | Viewed by 2418
Abstract
Immune checkpoint inhibitor-based therapies represent the current standard of care in the first-line treatment of advanced renal cell carcinoma. Despite a clear benefit in survival outcomes, a considerable proportion of patients experience disease progression; prospective data about second-line therapy after first-line treatment with [...] Read more.
Immune checkpoint inhibitor-based therapies represent the current standard of care in the first-line treatment of advanced renal cell carcinoma. Despite a clear benefit in survival outcomes, a considerable proportion of patients experience disease progression; prospective data about second-line therapy after first-line treatment with immune checkpoint inhibitors are limited to small phase II studies. As with other solid tumors (such as melanoma and non-small cell lung cancer), preliminary data about the clinical efficacy of rechallenge of immunotherapy (alone or in combination with other drugs) in renal cell carcinoma are beginning to emerge. Nevertheless, the role of rechallenge in immunotherapy in this setting of disease remains unclear and cannot be considered a standard of care; currently some randomized trials are exploring this approach in patients with metastatic renal cell carcinoma. The aim of our review is to summarize main evidence available in the literature concerning immunotherapy rechallenge in renal carcinoma, especially focusing on biological rationale of resistance to immune checkpoint inhibitors, on the published data of clinical efficacy and on future perspectives. Full article
(This article belongs to the Special Issue Clinical Development of Drugs and Drug Combinations Modulating Immune Checkpoints in Cancer Therapy)
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