Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analysis of Yervoy™ (Ipilimumab) Treatment in More Than

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

  PR Newswire

  PRINCETON, New Jersey, September 27, 2013

PRINCETON, New Jersey, September 27, 2013 /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 (NYSE:BMY) 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™
(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

"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

"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™ (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.


1.Yervoy Summary of Product Characteristics. July 2011. Available at:∣=WC0b01ac058001d124
    Last accessed September 2013.

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