Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analysis of Yervoy(TM) (Ipilimumab) Treatment in More Than 1,800 Patients with Metastatic or Locally Advanced or Unresectable Mela

Princeton, New Jersey (ots/PRNewswire) -

- In this pooled analysis of 12 studies, a plateau in the survival curve
begins at approximately three years, with some patients followed for up to ten years
- Three-year estimated survival rate of 22% observed in patients treated with
ipilimumab
- Findings are based on different doses and regimens and show consistency of
long-term survival data for ipilimumab in metastatic melanoma
- Data presented as a late-breaker at the 2013 European Cancer Congress and
highlighted at Congress press briefing

Bristol-Myers Squibb Company today announced results from a
pooled analysis of survival data for 12 studies (n=1,861) in patients
with metastatic or locally advanced or unresectable melanoma who were
treated with Yervoy(TM) (ipilimumab) at different doses and regimens.
A plateau in the survival curve begins at approximately three years,
with follow-up of up to ten years in some patients. Approximately 22%
of patients were alive at three years. The data will be presented at
the 2013 European Cancer Congress on September 28 at 1:00 p.m. CEST
and were highlighted at a Congress press briefing (Abstract # 24LBA,
"Pooled analysis of long-term survival data from Phase 2 and Phase 3
trials of ipilimumab in metastatic or locally advanced, unresectable
melanoma").

Safety data were not included in this analysis. However, safety
data from these individual studies have been reported. Overall, the
types of adverse events (AEs) attributed to ipilimumab are generally
mechanism (immune)-based. Ipilimumab can result in severe and fatal
immune-related adverse reactions due to T-cell activation and
proliferation. In these clinical trials, adverse events associated
with ipilimumab were managed with protocol-specific guidelines,
including the administration of systemic corticosteroids, dose
interruption/discontinuation and/or other immunosuppressants.

"This pooled analysis reinforces the long-term survival data seen
in the individual studies and provides additional insight into the
overall survival of metastatic melanoma patients treated with
ipilimumab," said Brian Daniels, senior vice president, Global
Development and Medical Affairs. "The durability and consistency of
long-term survival observed in this analysis is encouraging as we
continue to advance the research and development of our
immuno-oncology portfolio."

"In this analysis, approximately 26% of treatment-naïve and 20% of
previously treated patients were alive at three years after being
treated with an ipilimumab regimen," said F. Stephen Hodi, M.D.,
Department of Medicine, Harvard Medical School, Dana-Farber Cancer
Institute. "This pooled analysis is encouraging, particularly when
considering that metastatic melanoma is one of the most aggressive
forms of cancer and historically, average survival was just six to
nine months."

About The Analysis

This pooled analysis was conducted to provide a more precise
estimate of the long-term survival effect of ipilimumab in patients
with metastatic melanoma. It is comprised of patient-level data from
12 prospective and retrospective studies, including two Phase 3
trials (n=790), eight Phase 2 trials (n=821), and two retrospective,
observational studies (n=250), which have been or will be reported on
as individual studies. Three studies included OS follow-up in some
patients for up to ten years.

The analysis included both previously-treated (n=1,257) and
previously untreated patients (n=604) who received ipilimumab at
different doses and regimens. The majority of patients received
ipilimumab 3 mg/kg (n=965) or at 10 mg/kg (n=706). Ipilimumab was
given every 3 weeks for 4 doses, and most studies included the option
to receive either ipilimumab retreatment or ipilimumab maintenance
therapy for eligible patients.

About ipilimumab

Ipilimumab, which is a recombinant, human monoclonal antibody,
blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4).
CTLA-4 is a negative regulator of T-cell activation. Ipilimumab binds
to CTLA-4 and blocks the interaction of CTLA-4 with its ligands,
CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell
activation and proliferation. The mechanism of action of ipilimumab's
effect in patients with melanoma is indirect, possibly through T-cell
mediated anti-tumor immune responses. On March 25, 2011, the FDA
approved ipilimumab 3 mg/kg monotherapy for patients with
unresectable or metastatic melanoma. In July 2011, the EU approved
ipilimumab 3 mg/kg for the treatment of adult patients with
previously-treated unresectable or metastatic melanoma. Yervoy(TM)
(ipilimumab) is now approved in more than 40 countries.

For full Prescribing Information, please refer to the SMPC.[1]

YERVOY is a registered trademark of Bristol-Myers Squibb Company.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines that
help patients prevail over serious diseases.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. 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.
Forward-looking statements in this 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, 2012, in our Quarterly Reports
on Form 10-Q and our 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.

Reference

1) Yervoy Summary of Product Characteristics. July 2011. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002213/human_med_001465.jsp&mid=WC0b01ac058001d124
Last accessed September 2013.

ots Originaltext: Bristol-Myers Squibb GmbH & Co.KG aA
Im Internet recherchierbar: http://www.presseportal.de

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