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This activity has been sponsored by Clinigen, Inc. (“Clinigen”) and Prometheus Laboratories, Inc. (“Prometheus”). Prometheus owned the US rights to Proleukin® when this activity initiated. Clinigen now owns the global rights to Proleukin, having completed acquisition of the US rights in April 2019. Prometheus and Clinigen provided financial support and have had input into the selection of the faculty and/or the detailed project scope. This activity is provided by Touch Medical Communications (TMC) for touchONCOLOGY.

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Renal Cancer Watch Time: 17 mins

touchEXPERT BRIEFING The Role of High-Dose IL-2 in mRCC today

Watch leading experts discuss recent developments in checkpoint inhibitor therapy to treat mRCC,5,6 and the findings from a recent analysis of the PROCLAIMSM registry.

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Dr Scott S. Tykodi
University of Washington and Fred Hutchinson Cancer Research Center, WA, USA
The role of high-dose interleukin-2 in the treatment of mRCC patients

Dr Tykodi discusses the importance of clinical risk factors in the treatment of mRCC,3 when and how to treat mRCC with high-dose interleukin-2,1,3 recent developments in checkpoint inhibitor therapy,4 and how these might affect the role of high-dose interleukin-2 in the treatment of favorable-risk mRCC patients.5

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Interview Questions

In this interview, Dr Scott S. Tykodi answers the following questions:

  • Why are clinical risk factors important in the treatment of patients with MRCC?
  • What are the key considerations when deciding whether to treat an MRCC patient with HD IL-2 therapy, and do these factors influence clinical outcomes?
  • In the recent Motzer et al. study, combination therapy with ipilimumab and nivolumab was shown to have less efficacy on OS compared with sunitinib in favorable-risk MRCC patients, but greater efficacy in intermediate/poor-risk patients – what do you think might be the reason for this?
  • Do you think HD IL-2 might help to address this issue, and is there a rationale for combination therapy with HD IL-2 and checkpoint inhibitors in MRCC?
About Dr Scott S. Tykodi

Dr Scott S. Tykodi is Associate Professor at the Division of Medical Oncology, University of Washington and Associate Professor at the Clinical Research Division, Fred Hutchinson Cancer Research Center, WA, USA.

Dr Tykodi specializes in translating immunotherapy advances from the laboratory into the clinic, particularly natural or induced T-cell immunotherapies targeting renal cell carcinoma and melanoma. He has led numerous clinical trials evaluating novel, immune-based therapeutics for patients with kidney cancer or other solid tumors.

Disclosures:
Clinical research support (on behalf of his institution): Bristol-Myers Squibb, Calithera Biosciences, Clinigen, Exelixis, Merck, Nektar Therapeutics, Peloton Therapeutics, Pfizer, Prometheus and Jounce Therapeutics.
In addition, Scott S. Tykodi has a provisional patent application pending broadly relevant to the work.

 
Dr Brendan Curti
Providence Cancer Institute, Portland, OR, USA
Safety and efficacy of high-dose interleukin-2 in mRCC patients: Results from the PROCLAIMSM database

Dr Curti discusses recent analyses of data from the PROCLAIMSM database, with a focus on high-dose interleukin-2 therapy,2,5 the safety of high-dose interleukin-2 in favorable-risk mRCC patients,1 how these findings might affect the treatment paradigm for mRCC and potential future research to improve patient outcomes and survival.

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Interview Questions

In this interview, Dr Brendan Curti answers the following questions:

  • Do you think the results of the recent analysis of data from the PROCLAIM study will impact the treatment paradigm for MRCC, and if so, how?
  • Do you think similar results would be observed in other indications for HD IL-2 therapy, such as metastatic melanoma?
  • What was the safety profile of HD-IL-2 in favorable-risk MRCC patients?
  • What potential HD IL-2 combination therapies should be researched, to further augment the initial response rate and OS of HD IL-2 therapy in favorable-risk patients with MRCC?
About Dr Brendan Curti

Dr Brendan Curti is Director of the Melanoma Program, Cytokine and Adoptive Immunotherapy and Genitourinary Oncology Research at the Providence Cancer Institute, Portland OR, USA. He has also served as a Senior Investigator at the National Cancer Institute and an Associate Professor at the Penn State College of Medicine.

Dr Curti was the first recipient of the Robert W. Franz Endowed Chair for Clinical Research at Providence. His research and clinical focus centers around translational research and the development of new immunotherapies to treat a variety of cancers, including prostate carcinoma, renal cell carcinoma, bladder cancer and melanoma.

Disclosures:
Clinical research support: AstraZeneca, Clinigen, Galectin Therapeutics, Prometheus and the National Institutes of Health (R21CA190790, R21CA176705).
Institutional grants: AstraZeneca, Bristol-Myers Squibb, Prometheus, and Merck.
Paid consultancy: Clinigen, Prometheus, Replimune, and Merck
Unpaid consultancy: Agonox and Ubivac.

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Overview & Learning Objectives
Overview

High-dose interleukin-2 therapy is one of the few treatments for adults with metastatic renal cell cancer (mRCC) that can produce complete responses that are often durable for decades without further therapy.1-3 We interviewed leading experts about the current status of high-dose interleukin-2 therapy,1 when and how it should be considered,4 recent developments in checkpoint inhibitor therapy to treat mRCC,5,6 the findings from a recent analysis of the PROCLAIMSM registry into the efficacy of high-dose interleukin-2 therapy in favorable-risk mRCC patients,2,7 and the impact of these developments on the overall treatment paradigm.

Learning Objectives

After watching this activity, you should be able to:

  • Understand the importance of clinical risk factors in the treatment and management of mRCC and be aware of the current NCCN recommendations.
  • Appreciate the clinical benefits and safety profile, including risks, of high-dose interleukin-2 therapy and how these may guide treatment decisions dependent on clinical risk factors.
  • Demonstrate an awareness of the results of the CheckMate 214 study, showing differing survival and clinical response outcomes in patients with mRCC receiving checkpoint inhibitor therapy dependent on disease risk category.
  • Understand the latest results from the PROCLAIMSM database, showing consistent survival benefits with high-dose interleukin-2 therapy across favorable, intermediate and poor-risk mRCC patients.
  • Appreciate how these recent findings might alter the treatment paradigm for mRCC.
Prescribing Information
Prescribing Information

Clinigen, Inc. PROLEUKIN® (aldesleukin) prescribing information.

Adverse Events
Adverse Events

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC). You are encouraged to report negative side effects of prescription drugs to the FDA.

References
References
  1. Dutcher JP, et al. J Immunother Cancer 2014;2:26.
  2. Clark JI, et al. Clin Genitourin Cancer 2017;15:31-41 e4.
  3. Clinigen, Inc. PROLEUKIN® (aldesleukin) prescribing information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf
  4. National Comprehensive Cancer Network (NCCN), NCCN Clinical Practice Guidelines in Oncology. Available at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf
  5. Motzer RJ, et al. N Engl J Med 2018;378:1277-90.
  6. Buchbinder EI, et al. J Immunother Cancer 2019;7:49.
  7. Fishman M, et al. J Immunother Cancer 2019;7:84.
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