New Four- and Five-Year Survival Data for YERVOY® (ipilimumab) in Treatment-Naïve and Previously-Treated Metastatic Melanoma Presented at the ESMO 2012 Congress (European Society for Medical Oncology)

Princeton, New Jersey (ots/PRNewswire) -

- Long-Term Follow Up From Phase 3 Study (024) Demonstrated That 19.0
Percent of Treatment-Naïve Patients Who Received YERVOY at Investigational Dose of 10
mg/kg Plus Dacarbazine (DTIC) Were Alive at Four Years vs. 9.6 Percent of Patients
Treated with DTIC Alone
- Few New Immune-Related Adverse Events Occurred Beyond Two Years of Treatment
in Study 024
- Five-Year Follow Up from Three Exploratory Phase 2 Trials Add to Growing Body
of Survival Data for YERVOY in Metastatic Melanoma
- In Both Analyses, Updated Survival Rates Remained Relatively Stable Over Time

Bristol-Myers Squibb Company today announced four- and five-year
survival rates based on long-term follow up from Phase 3 and Phase 2
YERVOY(R) (ipilimumab) clinical trials in patients with
treatment-naïve and previously-treated metastatic melanoma. The data
were presented at the ESMO 2012 Congress (European Society for
Medical Oncology). (Abstract #1127 and 1116.)

In the Phase 3 trial (024), patients who had not previously
received treatment for metastatic melanoma (n=502) were randomized to
receive either the investigational dose of YERVOY 10 mg/kg in
combination with dacarbazine (DTIC, 850 mg/m[2]) or DTIC alone.
Long-term follow-up from this study demonstrated that treatment with
YERVOY plus DTIC resulted in a four-year survival rate of 19.0%
compared to 9.6% for DTIC alone. Additionally, the overall survival
data appeared relatively stable between years three and four for
patients treated with YERVOY plus DTIC (21.2% at three years and
19.0% at four years). The three and four-year survival rates for
patients treated with placebo plus DTIC were 12.1% and 9.6%,
respectively.

In three Phase 2 trials (007 [n=115], 008 [n=155] and 022
[n=217]) in which five-year follow-up data are available through a
rollover study (025), patients received YERVOY at 0.3 mg/kg, 3.0
mg/kg or 10 mg/kg. No comparator treatment arms were included in
these studies. In treatment-naïve patients, the five-year estimated
survival rates ranged from 38% to 49%, which was unchanged from the
four-year rates. In previously-treated patients, the five-year
estimated survival rates (12% to 28%) were relatively stable compared
to the rates at four years (14% to 28%).

For patients who were alive after four years and who continue on
therapy in study 024, few new immune-related adverse events occurred
beyond two years of treatment. Overall safety data from these
investigational studies have been previously presented.
[1],[2],[3],[4] The types of adverse events (AEs) attributed to
YERVOY in these studies were generally mechanism (immune)- based.
YERVOY can result in severe and fatal immune-related adverse
reactions due to T-cell activation and proliferation. Adverse events
associated with YERVOY were managed with protocol-specific
guidelines, including the administration of systemic corticosteroids,
dose interruption/discontinuation and/or other immunosuppressants.

"Metastatic melanoma is one of the most aggressive forms of
cancer with a historical five-year survival rate of less than ten
percent in patients with distant metastasis.[5] Results from these
investigational studies showed a prolonged survival benefit with
YERVOY at four and five years for some patients," said Celeste Lebbe,
M.D., Professor of Dermatology, Hôpital Saint-Louis. "These results
add to the growing body of long-term survival data seen in some
patients treated with YERVOY and further our understanding of the
potential of this immunotherapy in the treatment of metastatic
melanoma."

About Study 024

Study 024 is a multi-national, randomized, double-blind Phase 3
study that evaluated the safety and efficacy of YERVOY (10 mg/kg)
plus DTIC (850 mg/m[2]) vs. DTIC alone in treatment naive patients
with Stage III unresectable or Stage IV metastatic melanoma. Patients
who received prior adjuvant therapy were allowed in the trial.
Patients were randomly assigned in a 1:1 ratio to receive either
YERVOY plus DTIC (n=250) or DTIC plus placebo (n=252) at Weeks 1, 4,
7, 10 followed by DTIC alone every 3 weeks through Week 22 (induction
phase). If drug intolerance or progressive disease (PD) was noted
during Weeks 12-24, treatment was discontinued. At Week 24, patients
who had stable disease (SD) or an objective response (OR) during
induction with no dose-limiting toxicity could enter a maintenance
phase in which they received placebo or YERVOY every 12 weeks until
PD, drug intolerance or end of study. The primary endpoint of study
024 was overall survival. Results from study 024, which included
three-year follow-up data, were originally published in the New
England Journal of Medicine and presented at the American Society of
Clinical Oncology Annual Meeting in 2011.

The combination of DTIC with YERVOY is not an FDA
approved-regimen. In addition, study 024 was not designed to compare
the safety and efficacy of the FDA-approved monotherapy dose of 3
mg/kg for unresectable or metastatic melanoma vs. the investigational
dose of 10 mg/kg. Bristol-Myers Squibb is conducting a head-to-head
Phase 3 study comparing the safety and efficacy of the
currently-approved dose of 3 mg/kg vs. 10 mg/kg as monotherapy in
patients with previously-treated or treatment naïve unresectable or
metastatic melanoma. This study rapidly accrued patients and
completed enrollment in just over four months.

About Study 025

Study 025 is a rollover Phase 2 study that includes patients from
three trials who only received YERVOY: CA184-008, a single-arm study
of YERVOY 10 mg/kg in previously treated patients (n=155); CA184-022,
a dose-ranging study in which previously treated patients were
randomized to receive YERVOY at 0.3 mg/kg (n=73), 3 mg/kg (n=72), or
10 mg/kg (n=72) with crossover from lower doses to 10 mg/kg allowed
in patients whose disease progressed; and CA184-007, a randomized
study of YERVOY 10 mg/kg with or without prophylactic budesonide in
treatment-naïve (n=53) and previously treated patients (n=62).
Treatment was administered every 3 weeks for up to four doses, at
which point eligible patients could receive reinduction or
maintenance YERVOY every 12 weeks starting at week 24. The analysis
reported overall survival with updated last known alive date or death
based on data collected through March 2012.

About Metastatic Melanoma

Melanoma is a form of skin cancer characterized by the
uncontrolled growth of pigment-producing cells (melanocytes) located
in the skin. Metastatic melanoma is the deadliest form of the
disease, and occurs when cancer spreads beyond the surface of the
skin to other organs, such as the lymph nodes, lungs, brain or other
areas of the body. Some cancer cells can actively evade surveillance
by the immune system, allowing tumors to survive. Melanoma is mostly
curable when treated in its early stages. However, in its late
stages, the average survival rate is just 6 months with a 1-year
mortality rate of 75%, making it one of the most aggressive forms of
cancer. These rates are based on a meta-analysis of 42 Phase 2 trials
of more than 2,100 previously-treated and treatment-naïve patients
with Stage IV metastatic melanoma conducted by multiple cooperative
groups from 1975-2005. The incidence of melanoma has been increasing
for at least 30 years. The median age at diagnosis for melanoma is 57
and the median age at death is 67.

About YERVOY

On 25March 2011, the US Food and Drug Administration (FDA)
approved ipilimumab 3 mg/kg for the treatment of patients with
unresectable (inoperable) or metastatic melanoma in the US. On 13
July 2011, the EU approved ipilimumab 3 mg/kg for the treatment of
adult patients with previously-treated unresectable or metastatic
melanoma.

YERVOY, which is a recombinant, human monoclonal antibody, is the
first FDA-approved cancer immunotherapy that blocks the cytotoxic T-
lymphocyte 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.

For full Prescribing Information, please refer to the SMPC.

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.

This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding product development. 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 product described in this release will become commercially
successful. 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, 2010, 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. Weber J, Thompson JA, Hamid O, et al. A randomized,
double-blind, placebo-controlled, phase II study comparing the
tolerability and efficacy of ipilimumab administered with or without
prophylactic budesonide in patients with unresectable stage III or IV
melanoma. Clin Cancer Res 2009;15:5591-5598.

2. Wolchok JD, Neyns B, Linette G, et al. Ipilimumab monotherapy
in patients with pretreated advanced melanoma: a randomised,
double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol
2010;11:155-164.

3. O'Day SJ, Maio M, Chiarion-Sileni V, et al. Efficacy and
safety of ipilimumab monotherapy in patients with pretreated advanced
melanoma: a multicentre, single-arm, phase II study. Ann Oncol
2010;21:1712-1717.

4. Thomas L, Wolchok JD, Garbe C, et al. Safety of ipilimumab in
patients (pts) with untreated, advanced melanoma alive beyond 2
years: Results from a phase III study. J Clin Oncol. 2012;30(15s):
abstract 8512.

5. National Comprehensive Cancer Network (NCCN) Web site. "NCCN
Clinical Practice Guidelines in Oncology (NCCN Guidelines):
Melanoma." Available at:
http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf
Accessed on September 19, 2012.

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

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