Study Supports Possible Use of Leukine as a Potential Adjuvant Therapy for High-Risk Melanoma Patients- Phase II Data Indicate Overall and Disease-Free Survival -
WAYNE, N.J., June 05, 2008 /PRNewswire/ -- Results from an adjuvant trial in high-risk melanoma patients demonstrated that a majority of patients treated with Leukine(R) (sargramostim) achieved disease-free and/or overall survival. These findings, which indicate Leukine's potential in this cancer setting, were released at the 44th annual meeting of the American Society of Clinical Oncology (ASCO).
Results from the Phase II study (ASCO abstract #20027) show that 60 percent of the 45 high-risk patients enrolled in the trial experienced disease-free survival and 64 percent of patients achieved overall survival at 21 months.
"Previous findings suggest that sargramostim may be a potential adjuvant therapy for high-risk melanoma patients," said E. George Elias M.D., Ph.D., Director of Maryland Melanoma Center. "The percentage of patients who achieved disease-free and overall survival in this trial provides further evidence that sargramostim may prove to be a viable treatment option for this patient population and that further study in Phase III trials are needed."
In this trial, adjuvant therapy with Leukine and a synergistic cytokine, IL-2, was generally well-tolerated in patients with high-risk melanoma following potentially curative surgery. Each patient received two years of adjuvant therapy: year one with Leukine and IL-2 and year two with only Leukine. Toxicities were mild to moderate and no hospitalizations were required.
"These data, particularly the overall survival rates, are encouraging, even though preliminary, and indicate Leukine's potential as a treatment in this setting," said Paul MacCarthy, M.D., FRCPI, vice president and head of U.S. Medical Affairs for Bayer HealthCare Pharmaceuticals.
Clinical Trial Overview
This Phase II trial was a single-arm, open-labeled study to evaluate the safety, tolerability and treatment efficacy of Leukine and IL-2 in 45 patients who had undergone potentially curative surgery. In the first year of treatment, Leukine was administered subcutaneously at 125mcg/m2/day for 14 consecutive days, followed by IL-2 subcutaneously at nine million IU/m2/day for four days. The patients then received no treatment for 10 days. Patients with resected large metastases that yielded approximately 100 X 106 tumor cells also received autologous whole cell vaccine starting at the second Leukine cycle.
During the second year of treatment, each patient received Leukine alone two times per week. In patients who experienced resected recurrence, the same adjuvant therapy was re-administered.
Follow-up ranged from one - 50 months (median 15.9). At the end of the trial, 32 of the original 45 patients were alive [9/13 stage IV, 16/25 stage III, and 7/7 stage II (3B/4C)]. The survival data were expressed by Kaplan- Meier, and showed disease-free survival of .60 [95 percent CI], and overall survival of .64 [95 percent CI] at 21 months. There was no statistical difference in survival by Log Rank between those who received only Leukine versus those treated by Leukine and IL-2 (p=.8), and there was no increase in the number of dendritic cells during or after Leukine administration in the 11 patients who donated blood for dendritic cell counts.
Leukine(R) (sargramostim) is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the United States in 1991, and is marketed by Bayer HealthCare Pharmaceuticals. Leukine is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults (greater than or equal to 55 years) with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the U.S. for use in four additional indications: myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation, and bone marrow transplantation failure or engraftment delay.
Leukine is available in two formulations, both of which are suitable for IV infusion and subcutaneous injection:
-- Liquid: 500 mcg/mL sterile solution in multi-use vial that may be stored for up to 20 days after vial has been entered -- Lyophilized powder: 250 mcg in single-use vial ready for sterile reconstitution
Important Safety Considerations
Leukine is contraindicated in patients with excessive leukemic blasts in bone marrow or peripheral blood (10%), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy. Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious or anaphylactic reactions occur, Leukine therapy should immediately be discontinued and appropriate therapy initiated. Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates or CHF; respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, pleural and or/pericardial effusion, supraventricular tachycardia, sequestration of granulocytes in the pulmonary circulation and dyspnea have been reported in patients after Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration. Adverse events occurring in 10% of AML patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, and anorexia. If ANC 20,000 cells/mm3 or if platelet counts 500,000 mm3, Leukine administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed. Leukine therapy should be discontinued if disease progression is detected during treatment.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer
HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
CONTACT: David Freundel of Bayer HealthCare Pharmaceuticals Inc.,+1-973-305-5310, email@example.com
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Posted: June 2008