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New Data Show Proleukin® (aldesleukin) Improves Patient Outcomes as First-Line Therapy for the Treatment of Patients with Metastatic Melanoma or Metastatic Renal Cell Carcinoma

15 May 2015

Analyses of PROCLAIM Patient Registry Data Suggest a Therapy-Enhancing Role with Checkpoint Inhibitors for Patients with mM, and Relevant First-Line Option for Patients with mRCC

SAN DIEGO, May 15, 2015 - Prometheus Laboratories Inc. today announced the acceptance of data from three clinical studies by the American Society of Clinical Oncology (ASCO) for their 51st annual meeting, to be held May 29 through June 2 in Chicago, IL.  Each study comprises an analysis derived from the PROCLAIMSM (PROLEUKIN® Observational Study to Evaluate the Treatment Patterns and Clinical Response in Malignancy) patient registry, a collection of ongoing, real-world data on the use of Proleukin® (aldesleukin) across 40 participating sites consisting of immunotherapy treatment centers and community oncologists. These data collected from leading academic and clinical institutions, may provide oncologists valuable insights into the sequencing and combination of immunotherapies for the treatment of metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC).

Prometheus is presenting for the first time prospective data from the PROCLAIM registry (ClinicalTrials.gov number: NCT01415167) showing that Proleukin remains an effective front-line therapy, delivering durable long-term responses, for both mM and mRCC patients. New findings also reveal a potential therapy-enhancing role for Proleukin when sequenced with checkpoint inhibitors directed against the cytotoxic T lymphocyte antigen (anti-CTLA-4/ipilimumab) and programmed death receptor-1 (PD-1/pembrolizumab or nivolumab) pathways.

"These registry data provide valuable real-world evidence that can inform and direct ways to improve current practices while enhancing our knowledge of how to best navigate new treatment strategies using newer immunotherapy agents," said Joseph I. Clark, MD, FACP, Professor of Medicine in the Division of Hematology/Oncology at Loyola University Medical Center in Maywood, IL, and lead investigator in one of the studies to be presented at ASCO. "The collective findings from the analyses suggest that Proleukin continues to play a significant role in improving patient outcomes when sequenced and perhaps combined with novel immunotherapeutic agents."

The PROCLAIM national 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. 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. 

The PROCLAIM data presentations at ASCO underscore the value of Proleukin therapy at a time of heightened attention toward checkpoint inhibitor therapy as a novel immunotherapeutic approach. "Although the advent of checkpoint inhibitors has given us a new immunotherapy option for the treatment of metastatic disease, we are cognizant of the fact that checkpoint inhibitors have advanced the utility of immunotherapy for only the minority of patients who can achieve a long-term response," said Michael K. Wong, MD, PhD, professor of Medicine and Head of the Solid Tumor Section at the University of Southern California Norris Comprehensive Cancer Center. "The PROCLAIM registry findings confirms the efficacy of Proleukin as first-line therapy. As oncology research initiatives continue to yield new, innovative therapies, we hope to discover new ways to use Proleukin to improve patient outcomes by using tools such as the registry."

Notable Prometheus publications presented at ASCO include the following:
•Wong M, et al. Overall survival of metastatic melanoma (mM) treated with high dose IL-2 (HD IL-2) followed by anti-CTLA4 (IPI) and/or anti-PD-1/PD-L1 (aPD1) therapy: analysis of the prospective cohort of the PROCLAIM National Registry. Abstract #147120 (publication only).
•Gunturi A, et al. A retrospective analysis of high-dose aldesleukin (HD IL-2) following immune checkpoint blockade (ICB) in metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC). Saturday, May 30, 8:00-11:30AM, S Hall A,
General Poster Session: Abstract #3053.
•Clark J, et al. Impact of targeted therapy (TT) on survival of metastatic renal cell carcinoma (mRCC) patients treated with high dose interlukin-2 (HD IL-2): analysis of the PROCLAIM HD IL-1 National Registry. Abstract #146529 (publication only).

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 http://www.proleukin.com/.

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 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 Nestle Health Science in July 2011. Prometheus' corporate offices are located in San Diego, California. For more information about Prometheus, please visit www.prometheuslabs.com.

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