Updated Clinical Phase 2 data presented at American Society of Clinical
Oncology Annual Meeting
PRINCETON, N.J., June 1 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) today announced updated long-term follow-up and overall
survival (OS) results from a Phase 2 clinical study (MDX010-08) of 3 mg/kg
of ipilimumab in combination with dacarbazine (DTIC) where 11.4%, or 4 of
35 patients, were still alive at or greater than 4 years of follow-up. This
included 1 patient that experienced a complete response (4.7 years), 1
patient that experienced a partial response (4.2 years), 1 patient with
stable disease (4.6 years) and 1 patient with RECIST defined progressive
disease (4.4 years). The median OS for patients treated with ipilimumab in
combination with DTIC was 15 months in this study. These results compare
favorably with data in medical literature, in which median OS ranges from 6
to 9 months for patients with treated or previously untreated advanced
melanoma treated with standard chemotherapy. These findings were presented
at the Annual Meeting of the American Society of Clinical Oncology (ASCO),
being held in Chicago, IL May 30-June 3, 2008. (Abstract # 9022)
"The long-term survival data suggests that ipilimumab in combination
with DTIC may have long-lasting effects," said Geoffrey M. Nichol, MBChB,
Senior Vice President of Product Development at Medarex. "With a median
survival of approximately 15 months in the patients treated with 3 mg/kg of
ipilimumab in combination with DTIC in this Phase 2 study, we look forward
with interest to the outcome of the ongoing Phase 3 study being performed
by our collaborator Bristol-Myers Squibb Company, comparing 10 mg/kg of
ipilimumab in combination with DTIC versus DTIC alone in
previously-untreated patients with advanced melanoma."
In the Phase 2 trial (MDX010-08), 72 chemotherapy-naive patients with
advanced melanoma were treated with 3 mg/kg of ipilimumab monthly for four
months and were randomized to receive either ipilimumab in combination with
DTIC (n=35) or ipilimumab alone (n=37). Patients originally treated in the
MDX010-08 study were subsequently enrolled into study MDX010-028 to
determine long-term follow-up data and OS. The disease control rate
(proportion of patients with complete responses, partial responses or
stable disease) for patients treated with ipilimumab in combination with
DTIC was 37.1%, or 13 of 35 patients, with 2 complete responses, 3 partial
responses and 8 patients with stable disease. Two of 37 patients, or 5.4%,
treated with 3 mg/kg of ipilimumab alone experienced partial responses,
which were ongoing more than 4 years and 4.2 years in duration,
respectively. The disease control rate in the ipilimumab alone treatment
arm was 21.6%, or 8 of the 37 patients, with median OS of 12 months.
Ipilimumab is being developed through a joint partnership between
Bristol-Myers Squibb and Medarex. Based on preclinical and clinical studies
showing that antibody blockade of CTLA-4 plays an important role in
sustaining an active immune response to fight cancer, the companies are
pursuing a broad clinical development program with ipilimumab. More than
2,000 patients have been treated in clinical trials with ipilimumab as a
monotherapy or in combination with other agents. Patients in the ongoing
Phase 3 study (BMS study CA184-024) are randomized to receive induction
therapy with 10 mg/kg of ipilimumab in combination with DTIC or placebo.
Eligible patients are permitted maintenance dosing with ipilimumab or
placebo after the induction phase has been completed.
For further information about ipilimumab clinical trials, please visit
http://www.clinicaltrials.gov.
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 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 http://www.medarex.com.
Medarex Statement on Cautionary Factors
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
"suggests"; "potential"; or "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.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
SOURCE Medarex, Inc.
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CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880, x2216, or Nichol Harber, Corporate
Communications (media), +1-609-430-2880, x2214, both of Medarex,
Inc.
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