Data Presented at 33rd Congress of the European Society for Medical Oncology
PRINCETON, NJ, USA | September, 15 2008 | Bristol-Myers Squibb Company (NYSE: BMY) and Medarex, Inc. (NASDAQ: MEDX) today announced updated survival data from three Phase 2 studies of ipilimumab in patients with advanced metastatic melanoma (Stage III or IV) who had previously been treated. Study results show that approximately half of patients who received ipilimumab (10 mg/kg) remained alive beyond one year.
The results are based on follow-up of the patient population from studies 008, 022 and 007 treated with 10 mg/kg of ipilimumab (induction and maintenance) and show a consistent one-year survival rate between 47 and 51 percent. Specifically, the results show:
– One-year survival rate of 47 percent in patients who had progressed while on or after receiving standard treatment (Study 008, Abstract #776PD);
– One-year survival rate of 48 percent in patients who were previously treated, relapsed or failed to respond to experimental treatment or were unable to tolerate currently approved therapies (Study 022, Abstract #769O);
– One-year survival rate of 51 percent in patients previously treated with therapy other than ipilimumab (Study 007, Abstract #778PD).
Follow-up for survival was up to 24.8, 21.88 and 26.32 months in studies 008, 022 and 007, respectively.
Recent medical literature based on a meta-analysis of 42 Phase 2 trials with 2,100 patients reported a one-year survival rate of approximately 25 percent for patients with Stage III or IV metastatic melanoma, the most advanced type of the disease .
"Currently, there are few treatment options available for patients with advanced melanoma," said Michele Maio, M.D., Ph.D. Director, Division of Medical Oncology and Immunotherapy, University Hospital of Siena. "As these data on ipilimumab continue to mature, we are encouraged by the durability of response and consistency of survival results observed across all three Phase 2 studies.
" Safety results from the three studies were generally consistent with data from previously reported clinical trials of ipilimumab. The most common immune-related adverse events were rash, diarrhea and hepatitis. Grade 3 and 4 immune-related adverse event rates were approximately 20 to 28 percent and zero to 12 percent, respectively, in patients who received 10 mg/kg of ipilimumab. Adverse events were generally manageable and reversible within days or weeks with the use of supportive care and systemic steroids using established treatment guidelines in the majority of patients. Additional data on efficacy and survival with an active control group will come from an ongoing Phase 3, randomized, double-blind study (024) assessing ipilimumab (10 mg/kg) in combination with dacarbazine (DTIC) versus DTIC alone in patients with untreated, unresectable Stage III or Stage IV metastatic melanoma. A Phase 3 study (029) of ipilimumab administered as adjuvant therapy in patients with high-risk Stage III metastatic melanoma is also currently being conducted.
"We are excited by the consistent one-year survival rates among the three Phase 2 studies," said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. "Medarex and Bristol-Myers Squibb remain fully committed to the registrational program, including advanced melanoma, adjuvant melanoma, lung and prostate cancer trials."
About Studies 008, 022 and 007Z
The three studies enrolled a total of 487 patients across North America, Europe, South America, Africa and Australia with Stage III or Stage IV metastatic melanoma treated with 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of ipilimumab therapy. Approximately half of the patients in each of the trials had stage M1c disease, which indicates that cancer has spread to internal organs. M1c disease can also be associated with an elevated level of serum cholesterol and lactate dehydrogenase (LDH) and is typically indicative of the worst prognosis. Additionally, 10 percent of patients in study 007 had brain metastases at baseline as determined by an Independent Review Committee (IRC). Specifically, the three Phase 2 monotherapy trials include:
– A Phase 2 open-label, single-arm trial (008) evaluating overall response rate in 155 patients who progressed while on or after receiving standard treatment;
– A Phase 2 randomized, double-blind trial (022) evaluating the efficacy of three dose levels of ipilimumab in 217 patients who were previously treated, relapsed or failed to respond to experimental treatment or were unable to tolerate currently approved therapies; and
– A Phase 2 randomized, double-blind trial (007) evaluating the rate of Grade 2+ diarrhea in 115 patients receiving ipilimumab with or without prophylactic oral budesonide.
The primary endpoint of studies 008 and 022 was best overall response rate and the primary endpoint of study 007 was to compare the rate of Grade 2+ diarrhea in patients receiving ipilimumab with or without prophylactic oral budesonide. Overall survival, one-year survival rates, disease control rate, stable disease, and other measurements of anti-tumor activity and patterns of responses were secondary endpoints in studies 008, 022 and 007.
About Ipilimumab
Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. The absence or presence of CTLA-4 can augment or suppress the immune system’s T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells.
About Advanced Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. As with many cancers, it is more difficult to treat once the disease has spread beyond the skin to other parts of the body by way of the bloodstream or the lymphatic system (metastatic disease). Melanoma accounts for about three percent of skin cancer cases, but it causes most skin cancer deaths. The American Cancer Society estimates that in 2008, there will be 62,480 new cases of melanoma in the U.S., and about 8,420 people will die of this disease.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. More than 40 of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with seven of the most advanced product candidates currently in Phase 3 clinical trials or the subject of regulatory applications for marketing authorization. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world’s unmet healthcare needs. For more information about Medarex, visit its Web site at www.medarex.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.
SOURCE: Medarex, Inc.
Post Views: 59
Data Presented at 33rd Congress of the European Society for Medical Oncology
PRINCETON, NJ, USA | September, 15 2008 | Bristol-Myers Squibb Company (NYSE: BMY) and Medarex, Inc. (NASDAQ: MEDX) today announced updated survival data from three Phase 2 studies of ipilimumab in patients with advanced metastatic melanoma (Stage III or IV) who had previously been treated. Study results show that approximately half of patients who received ipilimumab (10 mg/kg) remained alive beyond one year.
The results are based on follow-up of the patient population from studies 008, 022 and 007 treated with 10 mg/kg of ipilimumab (induction and maintenance) and show a consistent one-year survival rate between 47 and 51 percent. Specifically, the results show:
– One-year survival rate of 47 percent in patients who had progressed while on or after receiving standard treatment (Study 008, Abstract #776PD);
– One-year survival rate of 48 percent in patients who were previously treated, relapsed or failed to respond to experimental treatment or were unable to tolerate currently approved therapies (Study 022, Abstract #769O);
– One-year survival rate of 51 percent in patients previously treated with therapy other than ipilimumab (Study 007, Abstract #778PD).
Follow-up for survival was up to 24.8, 21.88 and 26.32 months in studies 008, 022 and 007, respectively.
Recent medical literature based on a meta-analysis of 42 Phase 2 trials with 2,100 patients reported a one-year survival rate of approximately 25 percent for patients with Stage III or IV metastatic melanoma, the most advanced type of the disease .
"Currently, there are few treatment options available for patients with advanced melanoma," said Michele Maio, M.D., Ph.D. Director, Division of Medical Oncology and Immunotherapy, University Hospital of Siena. "As these data on ipilimumab continue to mature, we are encouraged by the durability of response and consistency of survival results observed across all three Phase 2 studies.
" Safety results from the three studies were generally consistent with data from previously reported clinical trials of ipilimumab. The most common immune-related adverse events were rash, diarrhea and hepatitis. Grade 3 and 4 immune-related adverse event rates were approximately 20 to 28 percent and zero to 12 percent, respectively, in patients who received 10 mg/kg of ipilimumab. Adverse events were generally manageable and reversible within days or weeks with the use of supportive care and systemic steroids using established treatment guidelines in the majority of patients. Additional data on efficacy and survival with an active control group will come from an ongoing Phase 3, randomized, double-blind study (024) assessing ipilimumab (10 mg/kg) in combination with dacarbazine (DTIC) versus DTIC alone in patients with untreated, unresectable Stage III or Stage IV metastatic melanoma. A Phase 3 study (029) of ipilimumab administered as adjuvant therapy in patients with high-risk Stage III metastatic melanoma is also currently being conducted.
"We are excited by the consistent one-year survival rates among the three Phase 2 studies," said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. "Medarex and Bristol-Myers Squibb remain fully committed to the registrational program, including advanced melanoma, adjuvant melanoma, lung and prostate cancer trials."
About Studies 008, 022 and 007Z
The three studies enrolled a total of 487 patients across North America, Europe, South America, Africa and Australia with Stage III or Stage IV metastatic melanoma treated with 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of ipilimumab therapy. Approximately half of the patients in each of the trials had stage M1c disease, which indicates that cancer has spread to internal organs. M1c disease can also be associated with an elevated level of serum cholesterol and lactate dehydrogenase (LDH) and is typically indicative of the worst prognosis. Additionally, 10 percent of patients in study 007 had brain metastases at baseline as determined by an Independent Review Committee (IRC). Specifically, the three Phase 2 monotherapy trials include:
– A Phase 2 open-label, single-arm trial (008) evaluating overall response rate in 155 patients who progressed while on or after receiving standard treatment;
– A Phase 2 randomized, double-blind trial (022) evaluating the efficacy of three dose levels of ipilimumab in 217 patients who were previously treated, relapsed or failed to respond to experimental treatment or were unable to tolerate currently approved therapies; and
– A Phase 2 randomized, double-blind trial (007) evaluating the rate of Grade 2+ diarrhea in 115 patients receiving ipilimumab with or without prophylactic oral budesonide.
The primary endpoint of studies 008 and 022 was best overall response rate and the primary endpoint of study 007 was to compare the rate of Grade 2+ diarrhea in patients receiving ipilimumab with or without prophylactic oral budesonide. Overall survival, one-year survival rates, disease control rate, stable disease, and other measurements of anti-tumor activity and patterns of responses were secondary endpoints in studies 008, 022 and 007.
About Ipilimumab
Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. The absence or presence of CTLA-4 can augment or suppress the immune system’s T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells.
About Advanced Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. As with many cancers, it is more difficult to treat once the disease has spread beyond the skin to other parts of the body by way of the bloodstream or the lymphatic system (metastatic disease). Melanoma accounts for about three percent of skin cancer cases, but it causes most skin cancer deaths. The American Cancer Society estimates that in 2008, there will be 62,480 new cases of melanoma in the U.S., and about 8,420 people will die of this disease.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. More than 40 of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with seven of the most advanced product candidates currently in Phase 3 clinical trials or the subject of regulatory applications for marketing authorization. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world’s unmet healthcare needs. For more information about Medarex, visit its Web site at www.medarex.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.
SOURCE: Medarex, Inc.
Post Views: 59
