Metastatic Melanoma
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Proleukin Results

Proleukin may offer the proven possibility to be cancer-free

In multiple clinical trials, Proleukin was well proven to help some people with metastatic melanoma who were good candidates for treatment*,†:

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Experienced complete disappearance of their cancer tumors (called durable complete response) for over 15 years*

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Had their tumors shrink (called partial response) by at least 50% or greater*

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Did not experience a relapse of their cancer if they maintained a response (complete or partial) for at least 2.5 years

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Maintained their response, ranging from over 3.5 years to over 15 years if they had a complete response. This occurred in nearly 60% (10 out of 17) of those who had a complete response

Had their cancer tumors stay the same (called stable disease), which means tumors did not grow by > 20% or shrink by > 30%, no new tumors developed, and cancer did not spread (metastasize) to other areas of their bodies (occurred in 22% to 38% of patients)

Responses to Proleukin were seen in metastatic sites, including the lung, liver, lymph node, spleen, adrenal glands, soft tissue, bone, and on, and underneath, the skin—no matter the size of tumors or amount of soft-organ involvement. Objective response was seen in 16% of patients with metastatic melanoma. In 6% of patients (17/270), tumors completely disappeared. In 10% (26/270) of patients, tumors shrank. Of course, everyone is different, and results may vary.
Know if it’s working early on

It’s very valuable to know as early as possible if treatment is helping. With Proleukin, your healthcare professional may be able to see results as early as 4 weeks after immunotherapy.

At least 90% of people who responded to Proleukin did so after their first course of treatment.*,† Some are still experiencing the joy of their Proleukin results for over 15 years—long after this short therapy has ended.

Know if it’s working early on
Well studied

Unlike new cancer therapies, Proleukin has been well researched and well studied for nearly 3 decades. Healthcare professionals are also familiar with Proleukin. They know what to expect, both during and long after treatment.†

Well studied

*

Objective response was seen in 16% of patients with metastatic melanoma. In 6% of patients (17/270), tumors completely disappeared. In 10% (26/270) of patients, tumors shrank.

†

Treatment with Proleukin is typically based on two 5-day cycles that constitute 1 course of therapy, with 9 days of rest in between. Patients who respond to Proleukin can go on to receive additional courses, while nonresponders are typically eligible for other treatment options.

Hope is possible with Proleukin
Hope is possible with Proleukin

Objective response was seen in 16% of patients with metastatic melanoma (6% had a complete response and 10% had a partial response). To learn more about Proleukin—and if it may be right for treating your metastatic melanoma—ask your healthcare professional.

kelly
“My Proleukin experience”

Actual metastatic melanoma survivor‡

‡Individual results may vary.

Compensation has been provided to share her experience.

Diagnosed with stage 3 melanoma while in high school, Kelli’s cancer returned as metastatic melanoma in 2005.§ “I was scared because I knew that the odds weren’t in my favor at that point. I had one very large mass that was pressing on my lungs and making it difficult for me to breathe,” says Kelli. “Treatment with Proleukin was harsh. I experienced severe nausea, vomiting, headaches, blood pressure drops, and fatigue. But if I had to do it again, I would. The nurses in the facility were so amazing at helping me train my thoughts to think about just doing what was ahead of me. At my follow-up visit, my oncologist revealed that there was no evidence of cancer. I finished college. I got married. I started a career. Now I have 4 beautiful babies. My message is: there’s hope.”

§

Kelli is a real person who has been cancer-free since 2005. Her experience isn’t representative of overall results with Proleukin. In Proleukin clinical studies, about 1 in 17 people with metastatic melanoma had no evidence of disease, ranging from 3 months to 10+ years. Objective response was seen in 16% of patients with metastatic melanoma (6% had a complete response and 10% had a partial response). Individual results may vary.
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Is Proleukin Right for You?
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Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC).

Summary of Important Safety Information for Proleukin® (aldesleukin) for injection, for intravenous infusion.

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (mRCC) and metastatic melanoma (mM).

Summary of Important Safety Information for Proleukin® (aldesleukin) for injection, for intravenous infusion.

WARNINGS

Therapy with Proleukin® (aldesleukin) 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.

 

INDICATIONS AND USAGE

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).

Proleukin is indicated for the treatment of adults with metastatic melanoma.

Careful patient selection is mandatory prior to the administration of Proleukin.

Evaluation of clinical studies to date reveals that patients with more favorable ECOG performance status (ECOG PS 0) at treatment initiation respond better to Proleukin, with a higher response rate and lower toxicity. Therefore, selection of patients for treatment should include assessment of performance status.

Experience in patients with ECOG PS > 1 is extremely limited.

 

CONTRAINDICATIONS

Proleukin® (aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation.

Proleukin is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. Retreatment with Proleukin is contraindicated in patients who have experienced the following drug-related toxicities while receiving an earlier course of therapy: sustained ventricular tachycardia (≥ 5 beats), cardiac arrhythmias not controlled or unresponsive to management, chest pain with ECG changes, consistent with angina or myocardial infarction, cardiac tamponade, intubation for > 72 hours, renal failure requiring dialysis > 72 hours, coma or toxic psychosis lasting > 48 hours, repetitive or difficult to control seizures, bowel ischemia/perforation, GI bleeding requiring surgery.

 

WARNINGS

Because of the severe adverse events which generally accompany Proleukin therapy at the recommended dosages, a thorough clinical evaluation should be performed to identify patients with significant heart, lung, kidney, liver or central nervous system impairment in whom Proleukin is not indicated for use. Patients with normal heart, lung, liver and central nervous system function may experience serious, life-threatening or fatal adverse events.

Should adverse events, requiring dose modification occur, dosage should be withheld rather than reduced.

Proleukin has been associated with exacerbation of preexisting autoimmune disease and inflammatory disorders. In some cases, the onset of new autoimmune diseases, such as vitiligo, may occur. Symptomatic hyperglycemia and/or diabetes mellitus have been reported during Proleukin therapy.

All patients should have thorough evaluation and treatment of CNS metastases and have a negative scan prior to receiving Proleukin therapy. New neurologic signs, symptoms, and anatomic lesions following Proleukin therapy have been reported in patients without evidence of CNS metastases. Neurologic signs and symptoms associated with Proleukin therapy usually improve after discontinuation of Proleukin therapy; however, there are reports of permanent neurologic defects. In patients with known seizure disorders, extreme caution should be exercised as Proleukin may cause seizures.

 

PRECAUTIONS

Patients should have normal cardiac, pulmonary, hepatic, and CNS function at the start of therapy. Capillary leak syndrome (CLS) begins immediately after Proleukin® (aldesleukin) treatment starts and is marked by increased capillary permeability to protein and fluids and reduced vascular tone.

Proleukin® (aldesleukin) treatment should be withheld for failure to maintain organ perfusion as demonstrated by altered mental status, reduced urine output, a fall in the systolic blood pressure below 90 mm Hg or onset of cardiac arrhythmias.

Recovery from CLS begins soon after cessation of Proleukin therapy. Usually, within a few hours, the blood pressure rises, organ perfusion is restored and reabsorption of extravasated fluid and protein begins.

Kidney and liver function are impaired during Proleukin treatment. Use of concomitant nephrotoxic or hepatotoxic medications may further increase toxicity to the kidney or liver.

Mental status changes including irritability, confusion, or depression which occur while receiving Proleukin may be due to bacteremia or early bacterial sepsis, hypoperfusion, occult CNS malignancy, or direct Proleukin-induced CNS toxicity. Patients should be evaluated for these and other causes of mental status changes. Alterations in mental status due solely to Proleukin therapy may progress for several days before recovery begins. Rarely, patients have sustained permanent neurologic deficits.

Proleukin enhancement of cellular immune function may increase the risk of allograft rejection in transplant patients.

Serious manifestations of eosinophilia involving eosinophilic infiltration of cardiac and pulmonary tissues can occur following Proleukin.

 

ADVERSE REACTIONS

The rate of drug-related deaths in the 255 metastatic RCC patients who received single-agent Proleukin® (aldesleukin) was 4% (11/255); the rate of drug-related deaths in the 270 metastatic melanoma patients who received single-agent Proleukin was 2% (6/270).

Adverse events are frequent, often serious, and sometimes fatal. The following adverse events (Grades 1-4) were seen in ≥ 30% of 525 patients (255 with metastatic kidney cancer and 270 with metastatic melanoma) treated with Proleukin: low blood pressure (71%), diarrhea (67%), low urine output (63%), chills (52%), vomiting (50%), shortness of breath (43%), rash (42%), increased bilirubin in blood (40%), decreased clotting of blood (37%), nausea (35%), confusion (34%), and decreased kidney function (33%).

Please see the full Prescribing Information, including Boxed Warning, for Proleukin® (aldesleukin) for injection, for intravenous infusion.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The content contained in this website is not intended to be a substitute for professional medical advice related to any topic discussed. Patients are urged to consult with their treating physicians or other professionals. Never disregard professional, medical, or legal advice or delay seeking such advice because of something you have read on this website.