Defining the critical hurdles in cancer immunotherapy Journal Article
| Authors: | Fox, B. A.; Schendel, D. J.; Butterfield, L. H.; Aamdal, S.; Allison, J. P.; Ascierto, P. A.; Atkins, M. B.; Bartunkova, J.; Bergmann, L.; Berinstein, N.; Bonorino, C. C.; Borden, E.; Bramson, J. L.; Britten, C. M.; Cao, X.; Carson, W. E.; Chang, A. E.; Characiejus, D.; Choudhury, A. R.; Coukos, G.; Wolchok, J. D.; Ritter, G. |
| Article Title: | Defining the critical hurdles in cancer immunotherapy |
| Abstract: | Scientific discoveries that provide strong evidence of antitumor effects in preclinical models often encounter significant delays before being tested in patients with cancer. While some of these delays have a scientific basis, others do not. We need to do better. Innovative strategies need to move into early stage clinical trials as quickly as it is safe, and if successful, these therapies should efficiently obtain regulatory approval and widespread clinical application. In late 2009 and 2010 the Society for Immunotherapy of Cancer (SITC), convened an "Immunotherapy Summit" with representatives from immunotherapy organizations representing Europe, Japan, China and North America to discuss collaborations to improve development and delivery of cancer immunotherapy. One of the concepts raised by SITC and defined as critical by all parties was the need to identify hurdles that impede effective translation of cancer immunotherapy. With consensus on these hurdles, international working groups could be developed to make recommendations vetted by the participating organizations. These recommendations could then be considered by regulatory bodies, governmental and private funding agencies, pharmaceutical companies and academic institutions to facilitate changes necessary to accelerate clinical translation of novel immune-based cancer therapies. The critical hurdles identified by representatives of the collaborating organizations, now organized as the World Immunotherapy Council, are presented and discussed in this report. Some of the identified hurdles impede all investigators; others hinder investigators only in certain regions or institutions or are more relevant to specific types of immunotherapy or first-in-humans studies. Each of these hurdles can significantly delay clinical translation of promising advances in immunotherapy yet if overcome, have the potential to improve outcomes of patients with cancer. © 2011 Fox et al; licensee BioMed Central Ltd. |
| Keywords: | treatment outcome; drug safety; nonhuman; unspecified side effect; drug approval; note; outcome assessment; antineoplastic agent; neoplasm; neoplasms; biological marker; cancer immunotherapy; editorial; practice guideline; antineoplastic activity; food and drug administration; cancer research; monoclonal antibody; europe; disease model; financial management; government; drug research; immune response; immunotherapy; cancer vaccine; patient safety; medical society; adoptive transfer; malignant neoplastic disease; tumor immunity; information dissemination; consensus development; immunoassay; japan; north america; reagent; international cooperation; translational research; china; drug industry; clinical trial (topic); tumor escape; good manufacturing practice; translational medical research |
| Journal Title: | Journal of Translational Medicine |
| Volume: | 9 |
| Issue: | 1 |
| ISSN: | 1479-5876 |
| Publisher: | Biomed Central Ltd |
| Date Published: | 2011-12-14 |
| Start Page: | 214 |
| Language: | English |
| PUBMED: | 22168571 |
| PROVIDER: | scopus |
| PMCID: | PMC3338100 |
| DOI: | 10.1186/1479-5876-9-214 |
| DOI/URL: | |
| Notes: | --- - Cited By (since 1996):21 - "Export Date: 7 May 2013" - ":doi 10.1186/1479-5876-9-214" - "Source: Scopus" |
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