Prometheus Laboratories Inc. Announces Inclusion of Proleukin® (Aldesleukin for Injection) / Interleukin?2 in SITC Guidelines for Treatment of Cutaneous Melanoma

SAN DIEGO, Oct. 10, 2013 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announces the inclusion of Proleukin^® (aldesleukin for injection) / Interleukin-2 in newly issued guidelines from the Society for Immunotherapy of Cancer (SITC) for the treatment of high risk and advanced- stage cutaneous melanoma. The guidelines, which appear in the August 23^rd issue of the journalNature Reviews in Clinical Oncology¹, are the first evidence-based consensus recommendations for the use of immunotherapy in the clinical management of patients with melanoma.

"The new SITC melanoma treatment guidelines address a growing need for guidance when selecting the appropriate sequence of therapies for patients with melanoma," said James Lowder, MD, Senior Director of Oncology Clinical Development and Medical Affairs at Prometheus. "We applaud SITC for developing these guidelines, as they expand the knowledge base for the treatment of melanoma and may ultimately lead to improved patient outcomes."

SITC, a non-profit professional organization dedicated to the basic understanding and clinical applications of tumor immunotherapy, convened a Melanoma Clinical Immunotherapy Guidelines Panel consisting of physicians, a nurse, and patient advocates who considered issues relating to patient selection, toxicity management, treatment cessation guidelines, and treatment sequencing. The resulting consensus statement incorporates findings from a search of the scientific literature focusing on current approaches to treatment of melanoma, a disease that "can be highly sensitive to immunotherapy," according to the panel.¹

"These new SITC guidelines recommend first-line use of high-dose Proleukin in a subset of patients with stage IV melanoma which aligns with NCCN melanoma treatment guidelines," added Dr. Lowder. "We are hopeful these new guidelines will further support the role of Proleukin in this setting, and increase access to Proleukin for appropriate metastatic melanoma patients. Proleukin remains an effective first-line option that provides a chance for a complete and durable response in some patients with metastatic melanoma²."

Observing that immunotherapeutic agents "are notable for their ability to produce a durable benefit in a subset of patients,"¹ the panel specifically cited evidence of consistent and durable responses to Proleukin therapy in eight phase II trials involving 270 patients.²
The panel recommended Proleukin as first-line therapy in the following types of patients with melanoma:¹

• Patients whose tumors harbor a BRAF mutation and who have good performance status and no central nervous system (CNS) disease
• Patients with BRAF negative melanoma who have good performance status and were treated for CNS disease

The panel also listed Proleukin as a second-line treatment for BRAF + patients who have poor performance status and CNS disease; and metastatic melanoma with a known KIT mutation.¹

To support their recommendations, the panel cited clinical data on the use of Proleukin, ipilimumab, and vemurafenib in treating stage IV melanoma, including single-arm Proleukin trials in which objective response rates of 16-17% — and complete response rates of 6-7% — were achieved.^3,4 The panelists also noted that 80-90% of complete responders to Proleukin therapy remain alive 10-15 years later², and that the durability and consistency of responses led the US Food and Drug Administration (FDA) to approve Proleukin for the treatment of metastatic melanoma in 1998.¹

"The SITC guidelines reflect a growing consensus that tumor immunotherapy is useful in the management of patients with melanoma, a disease with a steadily rising incidence rate and an annual cost of almost $2 billion⁵," commented Howard L. Kaufman, MD, lead author of the SITC consensus statement. "By issuing recommendations on the use of a number of proven immunotherapeutic interventions, we hope to facilitate evidence-based decision-making for physicians who are treating specific types of patients with melanoma," added Dr. Kaufman, who is director of the Rush University Cancer Center in Chicago, Ill.

Prometheus remains committed to enhancing patient education and access to appropriate immunotherapy treatment. To date, Prometheus has more than 105 treatment centers in the US that specialize in administering Proleukin therapy.  A convenient treatment center finder is available online here: https://secure.prometheuslabs.com/proleukin/mm/search-treatment-centers.aspx. Prometheus also offers the Proleukin Patient Assistance Program, at (877) 776-5385) and the Proleukin Product Information Line at (877-378-4919).  Such efforts ensure the timely provision of information to help physicians and patients make informed treatment decisions, while also providing financial and logistical support. 

About Proleukin
Proleukin (aldesleukin) for injection is a recombinant human interleukin-2 for treatment in adults with mM and mRCC, a type of 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 over 10 years in the treatment of mM and for over 20 years in the treatment of mRCC. Overall response rates (complete plus partial responses) were 16% in mM patients and 15% in mRCC patients.

Important Safety Information
Therapy with Proleukin (aldesleukin) should be restricted to patients with normal cardiac and pulmonary function 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.
Please see full Prescribing Information for Proleukin.

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. The corporate offices of Prometheus are located in San Diego, California. For more information about Prometheus, please visit www.prometheuslabs.com.

About Nestle Health Science
Nestle Health Science, a wholly-owned subsidiary of Nestle, intends to spearhead the development of science-based personalised nutritional solutions. Building on its core HealthCare Nutrition business, the company has ambitions to address chronic conditions in the area of Gastrointestinal Health, Metabolic Health and Brain Health. Nestle Health Science offers nutritional solutions for people with specific dietary needs related to illnesses, disease states or the special challenges of different life stages. Nestle Health Science employs around 3,000 people worldwide and has its headquarters in Vevey, Switzerland. For more information, please visit www.nestlehealthscience.com.

¹ Kaufman H, Kirkwood J, Hodi S, The Society for Immunotherapy of Cancer consensus statement on tumour immunotherapy for the treatment of cutaneous melanoma, Nature Reviews Clinical Oncology, August 27, 2013, 10.1038/nrclinonc.2013.153

² Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am 2000;6(Suppl 1):S11-4.

³ Rosenberg SA, Yang JC, Topalian SL, et al. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2. JAMA 1994;271:907-13.

⁴ Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol 1999;17:2105-16.

⁵ National Cancer Institute. Cancer Trends Progress Report—2011/2012 Update. Bethesda, MD: National Institutes of Health, Department of Health and Human Services; 2012. http://progressreport.cancer.gov.

SOURCE Prometheus Laboratories Inc.