New ipilimumab survival data in patients with metastatic melanoma presented at American Society of Clinical Oncology Annual Meeting



    MONTREAL, June 2 /CNW Telbec/ - Bristol-Myers Squibb Company (NYSE:   BMY)
and Medarex, Inc. (NASDAQ:   MEDX) announced yesterday preliminary survival data
for ipilimumab (10 mg/kg monotherapy), an investigational oncology
immunotherapy, in previously-treated patients with advanced metastatic
melanoma.
    Results of three Phase 2 studies (008, 022 and 007) and one Phase 1/2
study (MDX010-15), presented at the 44th Annual Meeting of the American
Society of Clinical Oncology, showed:

    
    - One-year projected survival rate of 46.7 percent and median overall
      survival of 10.2 months in patients who had progressed while on or
      after receiving standard treatment
      (Study 008, Abstract #9021);
    - One-year projected survival rate of 53.4 percent and median overall
      survival of 14.6 months 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 #9025);
    - One-year projected survival rate of 59.1 percent in treatment-naive
      patients and patients previously treated with therapy other than
      ipilimumab-at the time of analysis, the median overall survival had not
      been reached (Study 007, Abstract #9010); and
    - Two-year projected survival rate of 30 percent and median overall
      survival of 13.4 months in heavily pre-treated melanoma patients (Study
      MDX010-15, Abstract #3018).

    The median follow-up for survival in studies 008, 022 and 007 was 9.5, 8.9
and 10.9 months, respectively. The median follow-up for survival in study
MDX010-15 was 15.5 months.
    "Ultimately, when treating cancer patients with experimental cancer
therapies, the main objective is to extend their life expectancy," explains
Dr. Michael Smylie, Associate professor, Department of Oncology, Cross Cancer
Institute, Alberta. "The data provided by the ipilimumab studies are important
because investigators were able to observe an improvement of the one year
survival rate. Historically only about 25 to 30% of metastatic melanoma
patients are alive one year after diagnosis. Ipilimumab has the capacity to
enhance the immune response against tumors, which is vital in the case of
melanoma, as these types of treatments can be associated with long lasting
remissions. With ipilimumab, the body's immune system is better equipped to
aggressively fight the cancer."
    The four studies enrolled a total of 510 patients with Stage III or Stage
IV metastatic melanoma treated with10 mg/kg ipilimumab therapy. Approximately
half of the patients in each of the trials had stage M1c disease, which
indicates that melanoma metastases have spread to internal organs. M1c disease
can also be associated with an elevated level of serum LDH and is typically
indicative of the worst prognosis. 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. Long-term survival data from study MDX010-015 was collected in a
separate follow-up study (MDX010-28).
    Additional data presented from studies 008, 022 and 007, which further
demonstrated the potential clinical activity of ipilimumab at the 10 mg/kg
dosing regimen, included:

    - A statistically significant relationship between increased response
      rate and increased dose (p=0.0015) in study 022, favoring
      the 10 mg/kg regimen, as determined by independent radiology review
      (IRC); and
    - Disease control rates (proportion of patients with complete responses,
      partial responses or stable disease) of 27.1 percent (42 of 155),
      29.2 percent (21 of 72) and 35.1 percent (20 of 57) across studies 008,
      022 and 007, respectively.

    Investigators also discussed unique patterns of response observed in
studies 008, 022 and 007, which suggested that conventional criteria for
classifying short-term response and tumor progression may not accurately
capture the clinical activity observed with ipilimumab. For example, an
exploratory analysis utilizing endpoints that assessed total tumor burden
showed that some patients who received 10 mg/kg of ipilimumab can initially
demonstrate progression of the target lesion or new lesions but subsequently
go on to achieve responses. In these patients, both the initial lesion and new
lesions shrank in size or resolved with additional follow-up. The resulting
response rates observed by the investigators using the exploratory analyses
may correlate better with the survival data presented (Abstracts #3008 and
#3020).
    "Ipilimumab involves immune activation that begins early and builds an
immune response over time," said F. Steven Hodi, M.D., Clinical Director of
the Melanoma Program at Dana-Farber Cancer Institute. "The ipilimumab data
observed show patterns of response that are different from conventional
chemotherapy and underscore the need for criteria that more accurately
describe clinical activity and long-term benefit."
    Safety results from the four studies were generally consistent with data
from previously reported clinical trials of ipilimumab. The most common
immune-related adverse events (greater than five percent) were rash, diarrhea
and hepatitis, as well as endocrinopathies (four percent). The high-grade
(3/4) immune-related adverse event rate was approximately 20 to 40 percent in
patients who received 10 mg/kg of ipilimumab. The adverse events were
generally manageable and reversible within days or weeks with the use of
systemic steroids and established treatment guidelines in the majority of
patients.

    About the Studies
    -----------------

    The four studies enrolled patients across North America, Europe, South
America and Africa and included:

    - 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) in 115 patients
      comparing the safety of ipilimumab, with prophylactic oral budesonide
      or placebo (primarily evaluating the rate of grade 2+ diarrhea).
    - A Phase 1/2 trial (MDX010-15) evaluating the efficacy of the 10 mg/kg
      dosing regimen in 23 highly-refractory melanoma patients treated with
      ipilimumab.
    

    The primary endpoint of studies 008 and 022 was best overall response
rate and the primary endpoint of study 007 was to compare the safety of
ipilimumab with or without prophylactic oral budesonide. Top-line results from
these studies were previously announced. The primary endpoint of study
MDX010-15 was to determine the safety and pharmacokinetic profile of single
and multiple doses of ipilimumab.

    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).

    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.
    Except for the historical information presented herein, matters discussed
herein may constitute forward-looking statements, as defined in the Private
Securities Litigation Reform Act of 1995, that are subject to certain risks
and uncertainties that could cause actual results to differ materially from
any future results, performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including statements
preceded by, followed by, or that include the words; "potential"; "may"; or
similar statements are forward-looking statements. Medarex disclaims, however,
any intent or obligation to update these forward-looking statements. These
risks and uncertainties include whether the actual results in the clinical
studies described above will differ materially from results in future use of
ipilimumab, whether development of ipilimumab will be successful, whether the
clinical studies described in this release will support the filing of a BLA
with the FDA, or whether, if a BLA is filed with the FDA, it will be filed in
the timeframe developed by the parties or will receive regulatory approval, as
well as risks detailed from time to time in Medarex's public disclosure
filings with the U.S. Securities and Exchange Commission (SEC), including its
Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and its
quarterly reports on Form 10-Q. There can be no assurance that such
development efforts will succeed or that other developed products will receive
required regulatory clearance or that, even if such regulatory clearance were
received, such products would ultimately achieve commercial success. Copies of
Medarex's public disclosure filings are available from its investor relations
department.

    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.

    This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995, regarding the
research and development of ipilimumab. Such forward-looking statements are
based on current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and could
cause actual outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among other
risks, there can be no guarantee that the development of ipilimumab will be
successful or that the clinical studies described in this release will support
the filing of a Biological License Application (BLA) with the U.S. Food and
Drug Administration (FDA). Furthermore, there can be no assurances that if a
BLA is filed with the FDA, that it will be filed in the timeframe developed by
the parties or that such BLA will receive regulatory approval. There can be no
assurances that if approved, ipilimumab will be commercially successful.
Forward-looking statements in the press release should be evaluated together
with the many uncertainties that affect Bristol-Myers Squibb's business,
particularly those identified in the cautionary factors discussion in
Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December
31, 2007, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events, or otherwise.




For further information:

For further information: Muriel Haraoui, HKDP Communications and public
affairs, (514) 395-0375 ext. 235, mharaoui@hkdp.qc.ca; Marc Osborne, Director,
Public Relations, Bristol-Myers Squibb, (514) 333-2463, marc.osborne@bms.com

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