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PROCLAIMSM Patient Registry Data Demonstrate Survival Benefit of First-line Proleukin® Therapy in Patients with Metastatic Renal Cell Carcinoma

28 May 2015

Updated Survival Data and New Report from Prospective Cohort Suggest Benefits of Sequencing Proleukin Before Targeted Therapies

Chicago, Ill., May 28, 2015 –– Prometheus Laboratories, Inc. announced today the presentation of updated data from the PROCLAIMSM national patient registry in which first-line Proleukin® (aldesleukin for injection) therapy improved survival in patients with metastatic renal cell carcinoma (mRCC), compared to patients previously treated with targeted therapies. In a presentation at the 51st annual meeting of the American Society of Clinical Oncology (ASCO), researchers presented updated survival data from the PROCLAIM mRCC retrospective cohort, along with new data from the mRCC prospective cohort, that confirm the benefits of administering Proleukin in the first-line setting, showing that careful patient selection and drug sequencing may yield better treatment outcomes.

“The latest PROCLAIM data, which include the first report from the prospective cohort of patients with metastatic RCC, are consistent with previously reported survival data from the retrospective cohort,” said lead investigator Joseph I. Clark, MD, FACP, Professor of Medicine in the Division of Hematology/Oncology at Loyola University Medical Center in Maywood, IL. “In both cohorts, first-line high-dose interleukin-2 immunotherapy was associated with prolonged survival, compared to patients who first received targeted therapies. The survival benefit extended to patients previously categorized with stable disease, a population that had been grouped with non-responders to high-dose IL-2 therapy.”

In the presentation entitled, “Impact of Targeted Therapy (TT) on Survival of Metastatic Renal Cell Carcinoma (mRCC) Patients Treated with High Dose Interleukin-2 (HD IL-2): Analysis of the PROCLAIM HD IL-2 National Registry” (abstract #146529), Dr. Clark and colleagues unveiled the first results from 123 patients with mRCC enrolled in the prospective PROCLAIM cohort, along with updated overall survival (OS) data from the retrospective cohort. The overall response rate (ORR) in the prospective cohort was 17.9%. Patients from the prospective cohort who experienced a complete response (CR), partial response (PR), and stable disease (SD) had 2.5-year survival rates of 100%, 87%, and 73%, respectively. The median overall survival rate (mOS) in the prospective cohort was 29.6 months at a median follow-up of 23.2 months. The mOS was not reached (NR) in prospective-cohort patients treated with Proleukin only, compared to 13.1 and 29.6 months in those who had prior or post-Proleukin targeted therapy. Reported treatment-related mortality rate in the combined retrospective and prospective cohorts was 0.9% (4/435).

“Median overall survival in the PROCLAIM prospective cohort exceeds that observed in the studies that led to regulatory approval of IL-2 prior to the availability of tyrosine kinase inhibitor therapy, suggesting that proper sequencing of IL-2 and targeted therapies may enable improved outcomes in appropriate patients,” added co-investigator Michael Morse, MD, Professor of Medicine at Duke University School of Medicine. “As we continue to collect data in the prospective cohort, we hope to refine our understanding of which candidates are most likely to benefit from sequential therapy, and to use this knowledge to extend patients’ lives.” 


The PROCLAIMSM national patient registry, created in 2011, is the largest active collection of data from IL-2 treated patients and provides longitudinal real-time insights into how new therapies may affect patient outcomes. The registry encompasses over 40 participating sites, which include immunotherapy treatment centers and community oncology practices, and features a retrospective cohort of patients treated between 2007 and 2012, as well as an on-going prospective cohort of over 600 patients. PROCLAIM uses a protocol-driven methodology with built-in validation of data derived from ongoing treatment practices. The methodology maximizes the registry’s ability to rapidly detect associations and linkages between treatments and outcomes, thereby allowing for the creation of novel hypotheses that can be tested in clinical trials. 

About Proleukin®

Proleukin® (aldesleukin) for injection is a recombinant human interleukin-2 treatment for adults with metastatic melanoma and metastatic kidney cancer. Proleukin therapy is a form of immunotherapy that enhances the body’s natural immune system to help fight these types of cancer. Proleukin has been used for 17 years in the treatment of metastatic melanoma and for 20 years in the treatment of metastatic kidney cancer (renal cell carcinoma). For complete prescribing information, please visit

Important Safety Information
Therapy with Proleukin® (aldesleukin) for injection should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Proleukin administration has been associated with capillary leak syndrome (CLS), which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion, which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

Proleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of Proleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram-positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

About Interleukin-2

Interleukin-2 (IL-2) is a protein that occurs naturally in the body and plays an important role in activating the immune system. The immune system protects the body from foreign substances, cells, and tissues by responding to and resisting diseases. Proleukin therapy is a genetically engineered or recombinant version of IL-2. Proleukin therapy possesses the same biological properties as naturally occurring IL-2 and helps activate the immune system to recognize and eliminate certain kinds of cancer cells.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with more targeted solutions to optimize care for their patients. Prometheus became part of Nestlé Health Science in July 2011. Prometheus’ corporate offices are located in San Diego, California. For more information about Prometheus, please visit

Proleukin is a registered trademark of Novartis Vaccines & Diagnostics, Inc.