Bristol-Myers Squibb to Present New Data on 20 Types of Cancer from Across its Oncology Portfolio at ASCO and EHA 2019

May 16, 2019 Off By BusinessWire

New data on Opdivo (nivolumab) plus Yervoy (ipilimumab)
in patients with advanced hepatocellular carcinoma and in melanoma
patients with symptomatic brain metastases

New long-term survival data and health outcomes research on Opdivo
in combination with
Yervoy in advanced melanoma

Eighteen-month efficacy results for Empliciti (elotuzumab)
plus pomalidomide and low-dose dexamethasone for relapsed/refractory
multiple myeloma

Translational research exploring the use of novel technologies and
artificial intelligence to understand the association of inflammation
gene signatures with tumor immune cells

PRINCETON, N.J.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24BMY&src=ctag" target="_blank"gt;$BMYlt;/agt; lt;a href="https://twitter.com/hashtag/ASCO19?src=hash" target="_blank"gt;#ASCO19lt;/agt;–Bristol-Myers
Squibb Company
(NYSE:BMY) today announced the presentation of data
from across the company’s oncology portfolio at the American Society of
Clinical Oncology (ASCO) Annual Meeting 2019 in Chicago, May 31-June 4,
and the 24th Annual Congress of the European Hematology
Association (EHA) in Amsterdam, June 13-16. Data from over 90
Company-sponsored studies, investigator-sponsored studies and
collaborations evaluating oncology compounds and early translational
medicine across 20 types of cancer will be featured at the two meetings.
Presentations will highlight the role of Immuno-Oncology (I-O)
monotherapy and combination approaches in improving survival and quality
of life outcomes, as well as translational research investigating novel
biomarkers and diagnostics to aid in the selection of tailored
treatments for each patient based on their unique disease biology.

2019 ASCO Annual Meeting – Highlights of Bristol-Myers Squibb data
include:

*All times noted are Central Daylight Time

Hepatocellular Carcinoma

  • Primary efficacy and safety results from the Phase 1/2 CheckMate -040
    study evaluating the combination of Opdivo (nivolumab) plus Yervoy
    (ipilimumab) in patients with advanced hepatocellular carcinoma,
    the most common type of liver cancer, will be presented. These data
    (Abstract #4012), including objective response rate and overall
    survival, will be featured in a poster display on Monday, June 3 from
    8-11 AM CDT, and in a poster discussion from 3-4:30 PM CDT.

Melanoma

  • Safety and efficacy of Opdivo in combination with Yervoy
    in patients with symptomatic melanoma brain metastases (Abstract
    #9501) will be featured in an oral session on Tuesday, June 4, from
    9:45 AM-12:45 PM CDT.
  • New long-term survival data and health outcomes research evaluating Opdivo
    in combination with Yervoy in advanced melanoma—in terms of
    survival outcomes (CA209-004, Abstract #9533), quality of life after
    four years and during the treatment-free interval following
    discontinuation of therapy (CheckMate -067, Abstracts #9551 and
    #9568), and treatment-free survival (pooled data from CheckMate -067
    and -069, Abstract # 9550) – will be featured in a poster display on
    Monday, June 3 from 1:15-4:15 PM CDT.

Renal Cell Carcinoma

  • Safety and efficacy of Opdivo in combination with Yervoy
    in patients with asymptomatic advanced renal cell carcinoma brain
    metastases (Abstract #4517) will be featured in a poster display on
    Monday, June 3 from 1:15-4:15 PM CDT, and in a poster discussion from
    4:30-6 PM CDT.

Translational Medicine and Tumor Biology

  • Translational data to identify potentially predictive biomarkers and
    expand translational research capabilities will be presented. Through
    the use of gene expression profiling (GEP) and machine-learning
    modeling, a novel, tumor-associated inflammation gene signature was
    identified through correlative, immunohistochemistry assessment of CD8
    expression on T cells. This CD8-derived signature was then used to
    assess inflammation of the tumor microenvironment across 12 tumor
    types (Abstract #2593). Additionally, using an innovative artificial
    intelligence-based approach, combined with T-cell localization gene
    signatures by GEP, researchers quantified the abundance of immune
    cells and their spatial location within the tumor microenvironment
    (Abstract #2594). Both abstracts will be featured in a poster session
    on Saturday, June 1 from 8-11 AM CDT.

24th Annual Congress of the EHA – Highlights
of Bristol-Myers Squibb data include:

*All times noted are
Central European Standard Time

Multiple Myeloma

  • Extended 18-month follow-up data from the Phase 2 ELOQUENT-3 trial
    (Abstract #PS1370) evaluating the addition of Empliciti (elotuzumab)
    to pomalidomide and low-dose dexamethasone in relapsed/refractory
    (R/R) multiple myeloma, including a descriptive overall survival
    analysis for the combination, will be featured in a poster session on
    Saturday, June 15 from 5:30-7 PM CEST.

Classical Hodgkin and Non-Hodgkin Lymphoma

  • Updated safety and efficacy results in two patient subgroups from the
    Phase 2 CheckMate -744 study, the first risk-stratified,
    response-adapted study of Opdivo and ADCETRIS (brentuximab
    vedotin), followed by ADCETRIS and bendamustine for suboptimal
    response, in children, adolescents and young adults with R/R classical
    Hodgkin lymphoma (cHL), prior to autologous stem cell transplantation
    (Abstract #S822) will be presented in an oral presentation on
    Saturday, June 15 from 12:30-12:45 PM CEST.
  • Two-year results from cohort D of the Phase 2 CheckMate -205 study,
    evaluating Opdivo plus doxorubicin, vinblastine and dacarbazine
    in patients with newly diagnosed advanced-stage cHL (Abstract #S821),
    will be presented in an oral presentation on Saturday, June 15 from
    12:15-12:30 PM CEST.
  • A full analysis of the Phase 1/2 CheckMate -436 study, evaluating Opdivo
    and ADCETRIS in patients with R/R primary mediastinal large B-cell
    lymphoma (Abstract #S1601), will be presented in an oral presentation
    on Sunday, June 16 from 9-9:15 AM CEST.

2019 ASCO Annual Meeting – Company-sponsored and collaborative data
include:

*All times noted are Central Daylight Time

Gastrointestinal Malignancies

  • Nivolumab (NIVO) + ipilimumab (IPI) combination therapy in patients
    (pts) with advanced hepatocellular carcinoma (aHCC): Results from
    CheckMate 040

    Author: Yau
    Abstract: #4012
    Poster
    Discussion Session: Gastrointestinal (Noncolorectal) Cancer
    Monday,
    June 3, Poster Display: 8-11 AM, Hall A
    Discussion: 3-4:30 PM,
    Arie Crown Theater
  • Nivolumab (NIVO) + low-dose ipilimumab (IPI) as first-line (1L)
    therapy in microsatellite instability-high/DNA mismatch repair
    deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Clinical
    update

    Author: Lenz
    Abstract: #3521
    Poster
    Session: Gastrointestinal (Colorectal) Cancer
    Monday, June 3,
    Poster Display: 8-11 AM, Hall A

Melanoma

  • Long-term follow-up of CA209-004: A phase I dose-escalation study
    of combined nivolumab (NIVO) and ipilimumab (IPI) in patients with
    advanced melanoma

    Author: Atkins
    Abstract: #9533
    Poster
    Session: Melanoma/Skin Cancers
    Monday, June 3, Poster Display:
    1:15-4:15 PM, Hall A
  • Sensitivity of treatment-free survival (TFS), a novel outcome, to
    subgroup analyses of patients (pts) with advanced melanoma (MEL)
    treated with immune checkpoint inhibitors (ICI)

    Author:
    Mantia
    Abstract: #9550
    Poster Session: Melanoma/Skin Cancers
    Monday,
    June 3, Poster Display: 1:15-4:15 PM, Hall A
  • Patient-reported quality of life (QoL) of advanced melanoma
    patients in a Phase 3 study of nivolumab (NIVO) with or without
    ipilimumab (IPI) versus IPI: CheckMate 067 4-year data

    Author:
    Schadendorf
    Abstract: #9551
    Poster Session: Melanoma/Skin
    Cancers
    Monday, June 3, Poster Display: 1:15-4:15 PM, Hall A
  • Quality of life (QoL) and symptom burden in patients (pts) with
    advanced melanoma during the treatment-free interval (TFI) after
    discontinuation of nivolumab (NIVO) or NIVO plus ipilimumab (IPI)

    Author:
    Taylor
    Abstract: #9568
    Poster Session: Melanoma/Skin Cancers
    Monday,
    June 3, Poster Display: 1:15-4:15 PM, Hall A
  • An analysis of nivolumab-mediated adverse events and association
    with clinical efficacy in resected stage III or IV melanoma (CheckMate
    238)

    Author: Mandala
    Abstract: #9584
    Poster
    Session: Melanoma/Skin Cancers
    Monday, June 3, Poster Display:
    1:15-4:15 PM, Hall A
  • Efficacy and safety of the combination of nivolumab (NIVO) plus
    ipilimumab (IPI) in patients with symptomatic melanoma brain
    metastases (CheckMate 204)

    Author: Tawbi
    Abstract: #9501
    Oral
    Session: Melanoma/Skin Cancers
    Tuesday, June 4, 9:45 AM-12:45 PM,
    S406
    Presentation: 9:57-10:09 AM, S406

Genitourinary Malignancies

  • CheckMate 214 post-hoc analyses of nivolumab plus ipilimumab or
    sunitinib in IMDC intermediate/poor-risk patients with previously
    untreated advanced renal cell carcinoma with sarcomatoid features

    Author:
    McDermott
    Abstract: #4513
    Poster Discussion Session:
    Genitourinary (Nonprostate) Cancer
    Monday, June 3, Poster
    Display: 1:15-4:15 PM, Hall A
    Discussion: 4:30-6 PM, Hall D2
  • Safety and efficacy of nivolumab plus ipilimumab (NIVO+IPI) in
    patients with advanced renal cell carcinoma (aRCC) with brain
    metastases: Interim analysis of CheckMate 920

    Author:
    Emamekhoo
    Abstract: #4517
    Poster Discussion Session:
    Genitourinary (Nonprostate) Cancer
    Monday, June 3, Poster
    Display: 1:15-4:15 PM, Hall A
    Discussion: 4:30-6 PM, Hall D2
  • Consistent efficacy of nivolumab plus ipilimumab across number of
    International Metastatic Database Consortium (IMDC) risk factors in
    CheckMate 214

    Author: Escudier
    Abstract: #4575
    Poster
    Session: Genitourinary (Nonprostate) Cancer
    Monday, June 3,
    Poster Display: 1:15-4:15 PM, Hall A
  • Clinical and economic outcomes associated with sequential treatment
    in patients with advanced renal cell carcinoma (aRCC)

    Author:
    Regan
    Abstract: #4566
    Poster Session: Genitourinary
    (Nonprostate) Cancer
    Monday, June 3, Poster Display: 1:15-4:15
    PM, Hall A
  • Nivolumab monotherapy in patients with advanced platinum-resistant
    urothelial carcinoma: Efficacy and safety update from CheckMate 275

    Author:
    Siefker-Radtke
    Abstract: #4524
    Poster Session: Genitourinary
    (Nonprostate) Cancer
    Monday, June 3, Poster Display: 1:15-4:15
    PM, Hall A
  • Real-world outcomes with IO therapies: A prospective observational
    cohort study in patients (pts) with advanced melanoma (OPTIMIzE)

    Author:
    Kirkwood
    Abstract: #e14144
    Online Only

Translational Medicine and Biomarkers

  • Serum IL-6 and CRP as prognostic factors in melanoma patients
    receiving single agent and combination checkpoint inhibition

    Author:
    Weber
    Abstract: #100
    Clinical Science Symposium: Fine-Tuning
    Checkpoint Inhibition: Biomarkers of Response and Resistance
    Saturday,
    June 1, Clinical Science Symposium: 8-9:30 AM, Hall D1
    Presentation:
    8-8:12 AM, Hall D1
  • Development of a baseline prognostic cytokine signature that
    correlates with nivolumab (NIVO) clearance (CL): Translational
    pharmacokinetic/pharmacodynamic (PK/PD) analysis in patients with
    renal cell carcinoma (RCC)

    Author: Wang
    Abstract: #2544
    Poster
    Session: Developmental Immunotherapy and Tumor Immunobiology
    Saturday,
    June 1, Poster Display: 8-11 AM, Hall A
  • Association of an inflammatory gene signature with CD8 expression
    by immunohistochemistry (IHC) in multiple tumor types

    Author:
    Szabo
    Abstract: #2593
    Poster Session: Developmental
    Immunotherapy and Tumor Immunobiology
    Saturday, June 1, Poster
    Display: 8-11 AM, Hall A
  • CD8+ T cells in tumor parenchyma and stroma by image analysis (IA)
    and gene expression profiling (GEP): Potential biomarkers for
    immuno-oncology (I-O) therapy

    Author: Szabo
    Abstract:
    #2594
    Poster Session: Developmental Immunotherapy and Tumor
    Immunobiology
    Saturday, June 1, Poster Display: 8-11 AM, Hall A
  • Association of human endogenous retrovirus (hERV) expression with
    clinical efficacy of PD-1 blockade in metastatic clear cell renal cell
    carcinoma (mccRCC)

    Author: Pignon
    Abstract: #4568
    Poster
    Session: Genitourinary (Nonprostate) Cancer
    Monday, June 3,
    Poster Display: 1:15-4:15 PM, Hall A

New and Early Assets

  • Baseline tumor-immune signatures associated with response to
    bempegaldesleukin (NKTR-214) and nivolumab

    Author: Hurwitz
    Abstract:
    #2623
    Poster Session: Developmental Immunotherapy and Tumor
    Immunobiology
    Saturday, June 1, Poster Display: 8-11 AM, Hall A
  • CA224-060: A randomized, open label, phase II trial of relatlimab
    (anti-LAG-3) and nivolumab with chemotherapy versus nivolumab with
    chemotherapy as first-line treatment in patients with gastric or
    gastroesophageal junction adenocarcinoma

    Author: Feeney
    Abstract:
    #TPS4143
    Poster Session: Gastrointestinal (Noncolorectal) Cancer
    Monday,
    June 3, Poster Display: 8-11 AM, Hall A
  • CA045-001: A phase III, randomized, open label study of
    bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO
    monotherapy in patients (pts) with previously untreated, unresectable
    or metastatic melanoma (MEL)

    Author: Khushalani
    Abstract:
    #TPS9601
    Poster Session: Melanoma/Skin Cancers
    Monday, June
    3, Poster Display: 1:15-4:15 PM, Hall A
  • A phase III randomized open label study comparing bempegaldesleukin
    (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator’s
    choice) in patients with previously untreated advanced renal cell
    carcinoma

    Author: Tannir
    Abstract: #TPS4595
    Poster
    Session: Genitourinary (Nonprostate) Cancer
    Monday, June 3,
    Poster Display: 1:15-4:15 PM, Hall A
  • A phase 3 randomized study of neoadjuvant chemotherapy (NAC) alone
    or in combination with nivolumab (NIVO) ± BMS-986205 in
    cisplatin-eligible muscle invasive bladder cancer (MIBC)

    Author:
    Sonpavde
    Abstract: #TPS4587
    Poster Session: Genitourinary
    (Nonprostate) Cancer
    Monday, June 3, Poster Display: 1:15-4:15
    PM, Hall A

Clinical Collaborations

  • Preliminary immunogenicity, safety, and efficacy of JNJ-64041757
    (JNJ-757) in non-small cell lung cancer (NSCLC): Results from two
    phase 1 studies

    Author: Brahmer
    Abstract: #9093
    Poster
    Session: Lung Cancer-Non-Small Cell Metastatic
    Sunday, June 2,
    Poster Display: 8-11 AM, Hall A
  • An open label, multicenter, phase I/II study of RP1 as a single
    agent and in combination with PD1 blockade in patients with solid
    tumors

    Author: Middleton
    Abstract: #TPS2671
    Poster
    Session: Developmental Immunotherapy and Tumor Immunobiology
    Saturday,
    June 1, Poster Display: 8-11 AM, Hall A
  • Ph1/2 study of Rova-T in combination with nivolumab (Nivo) ±
    ipilimumab (Ipi) for patients (pts) with 2L+ extensive-stage (ED) SCLC

    Author:
    Malhotra
    Abstract: #8516
    Poster Session: Lung
    Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
    Sunday,
    June 2, Poster Display: 8-11 AM; Hall A
    Discussion: 11:15
    AM–12:45 PM, S406

24th Congress of the EHA – Company-sponsored
and collaborative data include:

*All times noted are Central
European Summer Time

Lymphoma

  • Nivolumab Plus Doxorubicin, Vinblastine and Dacarbazine for Newly
    Diagnosed Advanced-Stage Classical Hodgkin Lymphoma: 2-Year Extended
    Follow-Up From Cohort D of the Phase 2 CheckMate 205 Study

    Author:
    Domingo-Domènech
    Abstract: #S821
    Oral Session: Hodgkin
    lymphoma – Clinical
    Saturday, June 15, 11:30 AM-12:45 PM, Hall 5
    Presentation:
    12:15-12:30 PM, Hall 5
  • Nivolumab and Brentuximab Vedotin-Based, Response-Adapted Treatment
    in Primary Refractory and in Pediatric Patients with
    Relapsed/Refractory Classical Hodgkin Lymphoma in CheckMate 744

    Author:
    LeBlanc
    Abstract: #S822
    Oral Session: Hodgkin lymphoma –
    Clinical
    Saturday, June 15, 11:30 AM-12:45 PM, Hall 5
    Presentation:
    12:30-12:45 PM, Hall 5
  • Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory
    Primary Mediastinal Large B-cell Lymphoma: Efficacy and Safety Results
    from the Phase 2 CheckMate 436 Study

    Author: Zinzani
    Abstract:
    #S1601
    Oral Session: Aggressive lymphomas – First line,
    combination therapy and real-life data
    Sunday, June 16, 8-9:15
    AM, Hall 5
    Presentation: 9-9:15 AM, Hall 5

Multiple Myeloma

  • Elotuzumab Plus Pomalidomide and Dexamethasone for
    Relapsed/Refractory Multiple Myeloma: Efficacy Results After
    Additional Follow-Up of the Phase 2, Randomized ELOQUENT-3 Study

    Author:
    Dimopoulos
    Abstract: #PS1370
    Poster Session: Myeloma and
    other monoclonal gammopathies – Clinical
    Saturday, June 15,
    5:30-7 PM, Poster Area
  • Investigating Mechanisms of Elotuzumab and Lenalidomide in Multiple
    Myeloma

    Author: Richardson
    Abstract: #PF568
    Poster
    Session: Myeloma and other monoclonal gammopathies – Biology &
    Translational Research
    Friday, June 14, 5:30-7 PM, Poster Area
  • Use of Pomalidomide-Based Regimens in Relapsed/Refractory Multiple
    Myeloma in Four European Countries – Findings From PREAMBLE

    Author:
    Moreau
    Abstract: #PS1405
    Poster Session: Myeloma and other
    monoclonal gammopathies – Clinical
    Saturday, June 15, 5:30-7 PM,
    Poster Area

Leukemia

  • DASCERN 2-Year Extended Follow-Up of Dasatinib Efficacy and Safety
    in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase
    (CML-CP) Who Have Suboptimal Responses to 3 Months of Imatinib

    Author:
    Saglio
    Abstract: #PF405
    Poster Session: Chronic myeloid
    leukemia – Clinical
    Friday, June 14, 5:30-7 PM, Poster Area
  • DASFREE: 2-Year Update: Dasatinib Discontinuation in Patients (pts)
    with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) and Deep
    Molecular Response (DMR)

    Author: Shah
    Abstract: #PF408
    Poster
    Session: Chronic myeloid leukemia – Clinical
    Friday, June 14,
    5:30-7 PM, Poster Area
  • Growth Rate and Endocrine Effects of Dasatinib Therapy Observed in
    Retrospective Analysis of a Phase II Clinical Trial for Pediatric
    Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

    Author:
    Patterson
    Abstract: #PF416
    Poster Session: Chronic myeloid
    leukemia – Clinical
    Friday, June 14, 5:30-7 PM, Poster Area
  • Dosing Patterns of Dasatinib and Nilotinib Use in SIMPLICITY, an
    Observational Study in Chronic-Phase Chronic Myeloid Leukemia (CP-CML)
    Patients (pts) in Routine Clinical Practice

    Author: Cortes
    Abstract:
    #PS1181
    Poster Session: Chronic myeloid leukemia – Clinical
    Saturday,
    June 15, 5:30-7 PM, Poster Area

Bristol-Myers Squibb: Advancing Oncology
Research

At Bristol-Myers Squibb, patients are at the center of everything we do.
The focus of our research is to increase quality, long-term survival for
patients and make cure a possibility. Through a unique multidisciplinary
approach powered by translational science, we harness our deep
scientific experience in oncology and Immuno-Oncology (I-O) research to
identify novel treatments tailored to individual patient needs. Our
researchers are developing a diverse, purposefully built pipeline
designed to target different immune system pathways and address the
complex and specific interactions between the tumor, its
microenvironment and the immune system. We source innovation internally,
and in collaboration with academia, government, advocacy groups and
biotechnology companies, to help make the promise of transformational
medicines, like I-O, a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor
that is designed to uniquely harness the body’s own immune system to
help restore anti-tumor immune response. By harnessing the body’s own
immune system to fight cancer, Opdivo has become an
important treatment option across multiple cancers.

Opdivo’s leading global development program is based on
Bristol-Myers Squibb’s scientific expertise in the field of
Immuno-Oncology, and includes a broad range of clinical trials across
all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical
development program has treated more than 35,000 patients. The Opdivo trials
have contributed to gaining a deeper understanding of the potential role
of biomarkers in patient care, particularly regarding how patients may
benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint
inhibitor to receive regulatory approval anywhere in the world. Opdivo is
currently approved in more than 65 countries, including the United
States, the European Union, Japan and China. In October 2015, the
Company’s Opdivo and Yervoy combination regimen was the
first Immuno-Oncology combination to receive regulatory approval for the
treatment of metastatic melanoma and is currently approved in more than
50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO®

OPDIVO® (nivolumab) as a single agent is indicated for the
treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY®
(ipilimumab), is indicated for the treatment of patients with
unresectable or metastatic melanoma.

OPDIVO® (nivolumab) is indicated for the treatment of
patients with metastatic non-small cell lung cancer (NSCLC) with
progression on or after platinum-based chemotherapy. Patients with EGFR
or ALK genomic tumor aberrations should have disease progression on
FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of
patients with metastatic small cell lung cancer (SCLC) with progression
after platinum-based chemotherapy and at least one other line of
therapy. This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of
patients with advanced renal cell carcinoma (RCC) who have received
prior anti-angiogenic therapy.

OPDIVO® (nivolumab), in combination with YERVOY®
(ipilimumab), is indicated for the treatment of patients with
intermediate or poor risk, previously untreated advanced renal cell
carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult
patients with classical Hodgkin lymphoma (cHL) that has relapsed or
progressed after autologous hematopoietic stem cell transplantation
(HSCT) and brentuximab vedotin or after 3 or more lines of systemic
therapy that includes autologous HSCT. This indication is approved under
accelerated approval based on overall response rate. Continued approval
for this indication may be contingent upon verification and description
of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of
patients with recurrent or metastatic squamous cell carcinoma of the
head and neck (SCCHN) with disease progression on or after
platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of
patients with locally advanced or metastatic urothelial carcinoma who
have disease progression during or following platinum-containing
chemotherapy or have disease progression within 12 months of neoadjuvant
or adjuvant treatment with platinum-containing chemotherapy. This
indication is approved under accelerated approval based on tumor
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the
treatment of adult and pediatric (12 years and older) patients with
microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) metastatic colorectal cancer (CRC) that has progressed following
treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This
indication is approved under accelerated approval based on overall
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.

Contacts

Bristol-Myers Squibb Company
Media Inquiries:
Ken
Dominski
609-302-3114
[email protected]

Investors:
Tim Power
609-252-7509
[email protected]

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