Letter from the Editor
(1).jpg) Dear JITC Readers:
As the official journal of the Society for Immunotherapy of Cancer (SITC), the November edition of the Journal for ImmunoTherapy of Cancer (JITC) is pleased to announce two new educational resources, a research article on nivolumab dosing in different cancers and other outstanding papers. This edition contains the largest number of articles published in a month – a JITC milestone.
The first educational resource is "The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of renal cell carcinoma," which is the second disease-specific treatment guideline to be published by SITC. This manuscript provides expert recommendations and consensus opinion surrounding the use of interferon-α (IFN-α) and interleukin-2 (IL-2) in RCC. In addition, this manuscript includes information on the recent FDA approval of nivolumab and summarizes recent progress of biomarker development in RCC.
The second publication of note is a two-part white paper – Volume I and Volume II – from Working Group 1 (WG1) of the SITC Immune Biomarkers Task Force, which includes international cancer immunotherapy thought leaders from academia, government and industry. Volume I of the publication presents examples of current biomarker assays that have shown preliminary evidence of predictive value, to illustrate the requirements for pre-analytical and analytical steps in the biomarker development and validation process. As a continuation of the first paper, Volume II outlines the subsequent clinical and regulatory aspects of biomarker validation. Together, these manuscripts represent the first evidence-based recommendations to guide the validation process specifically for biomarkers developed to predict response to cancer immunotherapy.
Finally, in a research article this month titled “Nivolumab dose selection: challenges, opportunities and lessons learned for cancer immunotherapy,” Shruti Agrawal and colleagues report on the results of their efforts to identify unified nivolumab monotherapy dosing across tumor types in clinical trials for melanoma, non-small cell lung cancer and renal cell carcinoma. Their integration of dose-response/exposure-response (D-R/E-R) relationships with clinical safety and efficacy data provides a foundation for selecting a nivolumab dose in clinical situations where data are still limited.
With best regards,
Pedro J. Romero, MD
Editor-in-Chief, Journal for ImmunoTherapy of Cancer
Guidelines & Consensus Statements
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Society for immunotherapy of cancer consensus statement on immunotherapy for the treatment of renal cell carcinoma
Brian I. Rini, David F. McDermott, Hans Hammers, William Bro, Ronald M. Bukowski, Bernard Faba, Jo Faba, Robert A. Figlin, Thomas Hutson, Eric Jonasch, Richard W. Joseph, Bradley C. Leibovich, Thomas Olencki, Allan J. Pantuck, David I. Quinn, Virginia Seery, Martin H. Voss, Christopher G. Wood, Laura S. Wood and Michael B. Atkins
Journal for ImmunoTherapy of Cancer 2016, 4:81 (15 November 2016) |
From the Authors
"These guidelines lay the groundwork for the development and subsequent clinical implementation of novel immune-based agents by establishing consensus for the use of interferon-α and interleukin-2 as well as initiating the discussion around immune checkpoint inhibitors in renal cell carcinoma. We look forward to updating these guidelines as new immunotherapy agents become available to treat patients with kidney cancer."
Michael B. Atkins, MD — Georgetown-Lombardi Comprehensive Cancer Center
Immunotherapy Biomarkers Reviews
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Validation of biomarkers to predict response to immunotherapy in cancer: Volume I – pre-analytical and analytical validation
Giuseppe V. Masucci, Alessandra Cesano, Rachael Hawtin, Sylvia Janetzki, Jenny Zhang, Ilan Kirsch, Kevin K. Dobbin, John Alvarez, Paul B. Robbins, Senthamil R. Selvan, Howard Z. Streicher, Lisa H. Butterfield and Magdalena Thurin
Journal for ImmunoTherapy of Cancer 2016, 4:76 (15 November 2016) |
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Validation of biomarkers to predict response to immunotherapy in cancer: Volume II – clinical validation and regulatory considerations
Kevin K. Dobbin, Alessandra Cesano, John Alvarez, Rachael Hawtin, Sylvia Janetzki, Ilan Kirsch, Giuseppe V. Masucci, Paul B. Robbins, Senthamil R. Selvan, Howard Z. Streicher, Jenny Zhang, Lisa H. Butterfield and Magdalena Thurin
Journal for ImmunoTherapy of Cancer 2016, 4:77 (15 November 2016) |
From the Authors
"Optimizing biomarkers for cancer immunotherapy will be key to the continued success of these agents. Reliable biomarkers have the potential to guide patient selection for treatment, as well as defining disease progression and resistance to therapy, and can also help define mechanisms of action, identify rational combination approaches and guide the sequencing of therapies. As an outcome of Working Group 1 (WG1) of the SITC Immune Biomarkers Task Force, Volume I discusses the pre-analytic and analytic steps within the biomarker validation process, while Volume II addresses the process of clinical validation and aspects of regulatory approval. Together, these manuscripts serve as a valuable resource and provide recommendations for the entire biomarker validation process from preclinical discovery to regulatory approval."
Magdalena Thurin, PhD — National Cancer Institute
Research Articles
From the Authors
"Dose selection for immuno-oncology therapies usually occurs early in clinical development which may not fully represent the potential for improved overall survival. In this article, we describe an integrated methodology, utilizing phase 1b clinical activity, safety, dose/exposure-response and pharmacodynamic data, to inform selection of a unified optimal dose of the programmed death-1 inhibitor nivolumab across multiple advanced cancers."
Shruti Agrawal, PhD — Bristol-Myers Squibb
From the Authors
"Potentiating endogenous antitumor Th effector immunity can result in significant levels of tumor antigen-specific Th cells and CTL, the generation of long lasting immunity and a Th1 phenotype, resulting in the development of epitope spreading. Nevertheless, both CTL preexisting immunity and epitope spreading may have prognostic value for different clinical results depending on the nature of the tumor peptide and the restricting HLA allele, further emphasizing the ambiguity of circulating tumor-specific CTLs as predictors of clinical outcome."
Sonia A. Perez, PhD — Cancer Immunology and Immunotherapy Center, St. Savas Cancer Hospital
From the Authors
"In cervical cancer, downregulation of HLA class I – a major immune escape mechanism – was apparent in metastatic tumor cells compared to the primary tumor in both squamous cell carcinoma and adenocarcinoma. However, complete loss of classical HLA was found more frequently in patients with squamous cell carcinoma than in patients with adenocarcinoma. These findings emphasize the need for better immune characterization of cervical cancer histological subtypes and warrant further analysis of HLA expression as a biomarker for patient selection for CTL- and NK- cell based immunotherapeutic intervention."
Ekaterina S. Jordanova, PhD — VUMC, Free University Amsterdam
Case Report
From the Authors
"Falchook and colleagues report a durable complete response in a patient with metastatic cutaneous squamous cell carcinoma (CSCC), and a durable partial response in a patient with metastatic basal cell carcinoma (BCC), both treated with the anti-PD1 monoclonal antibody REGN2810. The authors propose that UV damage causes high mutation counts in CSCC and BCC, and that this is the basis by which these tumors can be recognized as 'foreign' by the immune system."
Matthew Fury, MD, PhD — Regeneron Pharmaceuticals, Inc.
From the Authors
"Lung cancer patients with prior history of malignant pleural or pericardial effusions can develop rapidly accumulating recurrent pleural effusions and cardiac tamponade within a few weeks of initiating therapy with nivolumab. Pseudoprogression should be considered in the differential diagnosis of such presentation, and could be a harbinger of response to therapy."
Bhaskar C. Kolla, MBBS — University of Minnesota
From the Authors
"Merkel cell carcinoma is a rare and aggressive cutaneous neuroendocrine malignancy with limited treatment options. This case report demonstrates a durable response of metastatic Merkel cell carcinoma to nivolumab and highlights the importance of PD1/PD-L1 inhibitors as a potential treatment option for patients with advanced or metastatic disease."
Frances Walocko, MSE — University of Michigan Medical School
From the Authors
"Many researchers believe that anti-cancer immunotherapy has the potential to eventually cure many types of cancer. There is a remarkable amount of data to back this up, but much remains unclear and further clinical trials will be necessary to answer the many outstanding questions. One of these questions is whether checkpoint inhibition may improve tumor response to radiation and vice versa."
Ammar Sukari, MD — Karmanos Cancer Center
Commentaries
From the Authors
"Assessment of validity for the immunoscore as a prognostic tool for HCC would be of great help in the management of patients affected by a disease with such great unmet clinical need. Indeed, it would allow the prediction of patients' prognosis according to their immunological classification."
Luigi Buonaguro, MD — National Cancer Institute 'Pascale'
From the Author
"Advances in DNA sequencing technologies have provided new methods to directly evaluate the abundance and diversity of immune cells (T cells) in tumors and in blood samples. These may provide novel means to identify individuals most likely to respond to different kinds of cancer immunotherapies."
Douglas G. McNeel, MD, PhD — University of Wisconsin – Madison
In Case You Missed It
Regular Abstracts presented at SITC’s 31st Annual Meeting & Associated Programs this past weekend were published on November 8 in the two-part supplement found below. For session summaries and other meeting highlights, refer to the SITC 2016 website. Late-Breaking Abstracts will be published in JITC on December 8.
October Highly Accessed Articles
 Clinical significance of tumor-infiltrating lymphocytes in breast cancer
Sasha E. Stanton and Mary L. Disis
Journal for ImmunoTherapy of Cancer 2016 4:59 (18 October 2016)
Anti-PD-1 increases the clonality and activity of tumor infiltrating antigen specific T cells induced by a potent immune therapy consisting of vaccine and metronomic cyclophosphamide
Genevieve M. Weir, Olga Hrytsenko, Tara Quinton, Neil L. Berinstein, Marianne M. Stanford and Marc Mansour
Journal for ImmunoTherapy of Cancer 2016 4:68 (18 October 2016)
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Categories
• Basic Tumor Immunology
• Case Reports
• Clinical/Translational Cancer Immunotherapy
• Clinical Trials Monitor
• Commentary/Editorials
• Immunotherapy Biomarkers
• Reviews
JITC Editor-in-Chief
Pedro J. Romero, MD – University of Lausanne
Section Editors
Lisa H. Butterfield, PhD – University of Pittsburgh Cancer Institute
Christian Capitini, MD – University of Wisconsin - Madison
Leisha Emens, MD, PhD – Johns Hopkins University
Robert L. Ferris, MD, PhD – University of Pittsburgh Cancer Institute
Thomas F. Gajewski, MD, PhD – University of Chicago
F. Stephen Hodi, Jr., MD – Dana-Farber Cancer Institute
Cornelis J.M. Melief, MD, PhD – ISA Therapeutics BV
Alfred Zippelius, MD – University Hospital Basel
To view the full editorial board, please click here.
SITC Members Receive Complimentary Article Processing Charges in 2016
As a thank you to our members, SITC is offering complimentary article processing charges throughout 2016 (a $2,500 USD savings). For your membership code, contact the SITC office at +1 (414) 271-2456.
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