Preliminary Analysis of Phase 2 Study Shows 53 Percent of Patients With Stage IV Metastatic Melanoma Survive One-Year Mark When Treated With Vitaxin(R)
Saturday May 14, 10:00 am ET
- Median Survival of Study Patients is 12.7 Months -
ORLANDO, Fla., May 14 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) today announced that preliminary data from a Phase 2 study involving 112 patients with stage IV metastatic melanoma showed a 12.7-month median survival for patients treated with Vitaxin alone. The data also showed a 9.4-month median survival for patients treated with Vitaxin plus dacarbazine (DTIC). In a recent Phase 3 trial, patients treated with DTIC alone, the current standard of care in advanced melanoma, had a median survival of 7.9 months.(1)
"From the data reported thus far, Vitaxin appears to have an acceptable safety profile and to prolong survival for patients with metastatic melanoma compared to what has been reported with standard therapy for this disease," said Dirk Reitsma, M.D., vice president, clinical development, oncology. "We intend to collect and analyze the final data set, and to review these findings with our advisory board and the Food & Drug Administration (FDA) as we determine our next steps in developing Vitaxin as a potential cancer therapy."
Vitaxin is MedImmune's development-stage monoclonal antibody (MAb) currently being evaluated in separate trials involving patients with advanced melanoma and prostate cancers. The data from the melanoma trial were presented at the 41st American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida.
Results from the Melanoma Study
The preliminary study data demonstrated that one-year survival rate was 53 percent for patients receiving Vitaxin alone (n=57), while the one-year survival rate was 42 percent for patients receiving Vitaxin plus DTIC (n=55). Twelve-months' data on three patients are still pending, two of these patients are in the Vitaxin alone arm. The median survival of the 112 patients was 12.7 months for those receiving Vitaxin alone, and 9.4 months for those patients receiving Vitaxin plus DTIC. Both arms of this study compare favorably to data reported for patients receiving DTIC alone (n=385), which was a control arm in a recently completed Phase 3 trial of Genasense® (oblimersen sodium), presented on May 3, 2004 at the FDA Oncology Drug Advisory Committee Meeting. In this separate trial, median survival for patients receiving DTIC alone was 7.9 months and it is estimated from this trial that approximately one-third of patients were alive at 12 months.
MedImmune's Phase 2 melanoma trial is a randomized, open-label study conducted at more than 20 sites in the United States, Australia and the United Kingdom. In the study, 112 patients with stage IV metastatic melanoma received weekly intravenous infusions of Vitaxin at a dose of 8.0 mg/kg either alone or in conjunction with 1,000 milligram per meter squared DTIC once every three weeks. To date, safety data suggest that Vitaxin has been generally well tolerated in these patients. Immunogenecity data are pending.
"I am excited to see the potential of Vitaxin used as a single agent for patients with metastatic melanoma," said Peter Hersey, M.D., conjoint professor of oncology, Newcastle Melanoma Unit, Australia, and presenter of the data at ASCO. "If the results from this Phase 2 study can be replicated in a controlled, pivotal study, Vitaxin might prove to be a major advance in the treatment of advanced melanoma, a disease where the only existing options have minimal therapeutic activity and considerable toxicity."
The title of the poster presented today at the ASCO meeting is "A Phase 2, Randomized, Open-Label Study Evaluating the Antitumor Activity of MEDI- 522, a Humanized Monoclonal Antibody Directed Against the Human Alpha v Beta 3 (avb3) Integrin, plus or minus Dacarbazine (DTIC) in Patients with Metastatic Melanoma."
Malignant melanoma, the most serious form of skin cancer, is now the tenth most common cancer in the U.S., responsible for nearly 80 percent of all deaths from skin cancer. It is the fastest-rising form of cancer among men and the second fastest form among women. Although five-year survival may approach 85 percent for melanoma patients diagnosed at the earliest stage, these rates decline precipitously once tumors have metastasized.
About Vitaxin
Vitaxin targets the alpha-v beta-3 integrin, which is a protein expressed on the surface of newly forming blood vessels, certain tumor types and on a number of other cell types, including macrophages and osteoclasts. Based on preclinical models, the alpha-v beta-3 integrin has been implicated in a number of disease processes, including the growth and metastasis of tumors and bone degradation. In addition to the Phase 2 trial in advanced melanoma, MedImmune is also currently conducting a Phase 2 trial in patients with androgen-independent prostate cancer that has metastasized to bone. The company completed enrolling 126 patients in this trial in April 2005.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With approximately 2,000 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website at medimmune.com. |
