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Bristol-Myers Squibb Research at ESMO Demonstrates Breadth of Oncology Development Program and Focus on Improving Overall Survival Across Multiple Cancers

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Overall survival data from CheckMate -227 Part 1 evaluating Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in advanced non-small cell lung cancer featured in ESMO Presidential Symposium

Five-year survival data on Opdivo plus Yervoy in advanced melanoma from CheckMate -067, the longest follow-up from a dual Immuno-Oncology Phase 3 trial

New data exploring potential of Opdivo and Opdivo plus Yervoy in esophageal, cervical and prostate cancers

Bristol-Myers Squibb Company (NYSE:BMY) today announced the presentation of clinical, translational and health outcomes research across 18 tumor types, highlighting the breadth of the company's innovative oncology development program at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, September 27 to October 1. Research will be presented from over 66 Bristol-Myers Squibb-sponsored studies, investigator-sponsored studies and collaborations, and includes new data on Opdivo and the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination that adds to the existing body of clinical evidence for these regimens to improve survival outcomes and quality of life for patients with cancer.

  • Final analysis of CheckMate -227 Part 1, which met its co-primary endpoint of overall survival, demonstrating a superior benefit for Opdivo plus low-dose Yervoy versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients whose tumors express PD-L1 ≥1%.
  • Five-year survival outcomes data from CheckMate -067 evaluating Opdivo plus Yervoy in advanced melanoma.
  • Three-year results on recurrence-free survival and distant metastasis-free survival from the Phase 3 CheckMate -238 trial investigating adjuvant Opdivo versus Yervoy in resected stage III/IV melanoma.
  • First presentation of Phase 3 data evaluating Opdivo versus chemotherapy in advanced esophageal cancer, which will be featured in an ESMO Presidential Symposium.
  • Interim results for Opdivo plus Yervoy in cervical cancer from the combination cohort of CheckMate -358.
  • Innovative translational research examining novel biomarkers and diagnostic pathways geared towards enabling a more precise and customized approach to care based on each patient's unique disease biology.
  • Health economic outcomes research encompassing real-world evidence in second-line lung cancer, head and neck cancer, and melanoma, as well as other novel types of evidence demonstrating the clinical value of Opdivo plus Yervoy versus targeted therapies in advanced melanoma and renal cell carcinoma.

"The breadth of data we are presenting at ESMO demonstrates our focus on research that delivers transformative therapies, explores new approaches in difficult-to-treat tumors and highlights the commitment we have to patients with cancer," said Fouad Namouni, head, Oncology Development, Bristol-Myers Squibb. "We look forward to sharing five-year overall survival data in advanced melanoma and final results from CheckMate -227 Part 1 in the first-line treatment of patients with non-small cell lung cancer, data from two of the three types of cancer where the Opdivo plus Yervoy regimen has shown an overall survival benefit in randomized Phase 3 trials."

Key Bristol-Myers Squibb data being presented at the ESMO 2019 Congress include:

Non-Small Cell Lung Cancer

  • Final efficacy and safety results from Part 1 of the Phase 3 CheckMate -227 study evaluating Opdivo plus low-dose Yervoy in patients with first-line NSCLC. These data (Presentation #LBA4_PR) will be featured in the official Press Programme and in a Presidential Symposium on Saturday, September 28 from 4:30-6:20 PM CEST.

Melanoma

  • Five-year survival outcomes from the Phase 3 CheckMate -067 trial evaluating the durability and sustained clinical benefit of Opdivo plus Yervoy in advanced melanoma. These data (Presentation #LBA68_PR) will be featured in the official Press Programme and in a Proffered Paper session on Saturday, September 28 from 8:30-10:15 AM CEST.
  • Three-year efficacy and biomarker results from the Phase 3 CheckMate -238 trial investigating adjuvant Opdivo versus Yervoy in resected stage III/IV melanoma. These data (Presentation #1310O) will be featured in a Proffered Paper session on Saturday, September 28 from 8:30-10:15 AM CEST.

Prostate Cancer

  • Phase 2 results from the CheckMate -9KD study assessing the clinical activity seen with Opdivo in combination with docetaxel in male patients with metastatic castration-resistant prostate cancer. These data (Presentation #LBA52) will be featured in a Poster Discussion on Sunday, September 29 from 8:30-9:45 AM CEST.

Gastrointestinal Cancer

  • First presentation of the final analysis from the randomized Phase 3 ATTRACTION-3 study evaluating Opdivo versus chemotherapy in patients with unresectable advanced or recurrent esophageal squamous cell carcinoma that is refractory to or intolerant of one prior fluoropyrimidine/platinum-based therapy. These data (Presentation #LBA11) will be featured in a Presidential Symposium on Monday, September 30 from 4:30-6:15 PM CEST.
  • Phase 3 results from the CheckMate -459 study of Opdivo compared to standard of care sorafenib as a first-line treatment in patients with advanced hepatocellular carcinoma. These data (Presentation #LBA38_PR) will be featured on Friday, September 27 in a Proffered Paper Session from 2-3:30 PM CEST.

Cervical Cancer

  • Interim analysis from the Opdivo plus Yervoy cohort of the Phase 1/2 CheckMate -358 study in patients with recurrent or metastatic cervical cancer. These data (Presentation #LBA62) will be featured in a Proffered Paper Session on Sunday, September 29 from 8:30-10 AM CEST.

Translational Medicine and Early Assets

  • Translational data from a clinical study will highlight a potential predictive composite biomarker approach to aid in the biology-driven selection of patients for Immuno-Oncology (I-O) therapy. These data (Presentation #1874O) will be featured in a Proffered Paper session on Saturday, September 28 from 8:30-10 AM CEST.
  • New findings featuring emerging technologies that enable deeper exploration of tumor biology and the tumor microenvironment, and may ultimately inform our approach to I-O resistance, will also be presented. Research on how spatial analysis of immune and tumor cells in gastric and urothelial tumors may impact use of predictive biomarkers for I-O therapy (Presentation #2021P) will be showcased in a Poster Display session on Saturday, September 28 from 12-1 PM CEST. Data highlighting the application of an artificial intelligence-based computed tomography imaging platform to detect early radiomic changes associated with sensitivity to treatment in patients with squamous NSCLC (Presentation #1910P) and the development of a multiplex chromogenic immunohistochemistry approach for simultaneous quantitation, spatial analysis and checkpoint expression of tumor infiltrating lymphocytes (Presentation #128P) will be presented in a Poster Display session on Monday, September 30 from 12-1 PM CEST.

Bristol-Myers Squibb-sponsored and collaborative data at the ESMO 2019 Congress

*All times noted are Central European Summer Time (CEST)

Melanoma

  • 5-year survival outcomes of the CheckMate 067 phase 3 trial of nivolumab plus ipilimumab (NIVO+IPI) combination therapy in advanced melanoma

    Author: Larkin

    Presentation Number: #LBA68_PR

    Session: Proffered Paper – Melanoma and other skin tumours

    Session Time: Saturday, September 28, 8:30-10:15 AM, Cordoba Auditorium (Hall 7)

    Presentation Time: 9:21-9:33 AM
  • Adjuvant nivolumab (NIVO) versus ipilimumab (IPI) in resected stage III/IV melanoma: 3-year efficacy and biomarker results from the phase 3 CheckMate 238 trial

    Author: Weber

    Presentation Number: #1310O

    Session: Profferred Paper – Melanoma and other skin tumours

    Session Time: Saturday, September 28, 8:30-10:15 AM, Cordoba Auditorium (Hall 7)

    Presentation Time: 8:54-9:06 AM
  • Mixture-cure modeling for resected stage III/IV melanoma in the phase 3 CheckMate 238 trial

    Author: Weber

    Presentation Number: #1331P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Long-term efficacy of combination nivolumab and ipilimumab for first-line treatment of advanced melanoma: a network meta-analysis

    Author: Mohr

    Presentation Number: #1347P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Long-term real-world (RW) outcomes in patients with advanced melanoma (MEL) treated with ipilimumab (IPI) and non-IPI therapies: IMAGE study

    Author: Dalle

    Presentation Number: #1348P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Health-related quality of life of advanced melanoma survivors treated with CTLA-4 immune checkpoint inhibition: a matched cohort study

    Author: Boekhout

    Presentation Number: #1621P

    Session: Poster Display Session 1

    Session Time: Saturday, September 28, 12-1 PM, Poster Area (Hall 4)

Renal Cell Carcinoma

  • Association between depth of response and overall survival: exploratory analysis in patients with previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 214

    Author: Grünwald

    Presentation Number: #950P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Quality of life in previously untreated patients with advanced renal cell carcinoma (aRCC) in CheckMate 214: updated results

    Author: Cella

    Presentation Number: #951P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Treatment-free survival, with and without toxicity, as a novel outcome applied to immuno-oncology agents in advanced renal cell carcinoma

    Author: Regan

    Presentation Number: #971P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Tailored immunotherapy approach with nivolumab in advanced renal cell carcinoma (TITAN-RCC)

    Author: Grimm

    Presentation Number: #LBA57

    Session: Proffered Paper 2 – Genitourinary tumours, non-prostate

    Session Time: Saturday, September 28, 2:45-4 PM, Sevilla Auditorium (Hall 2)

    Presentation Time: 3-3:15 PM
  • NIVOREN GETUG-AFU 26 translational study: CD8 infiltration and PD-L1 expression are associated with outcome in patients (pts) with metastatic clear cell renal cell carcinoma (mccRCC) treated with nivolumab (N)

    Author: Vano

    Presentation Number: #909PD

    Session: Poster Discussion – Genitourinary tumours, non-prostate

    Session Time: Sunday, September 29, 3-4:15 PM, Pamplona Auditorium (Hall 2)

    Discussion Time: 3:20-3:35 PM
  • A phase II trial of TKI induction followed by a randomized comparison between nivolumab or TKI continuation in renal cell carcinoma (NIVOSWITCH)

    Author: Grünwald

    Presentation Number: #959P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)

Genitourinary

  • Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD

    Author: Fizazi

    Presentation Number: #LBA52

    Session: Poster Discussion – Genitourinary tumours, prostate

    Session Time: Sunday, September 29, 8:30-9:45 AM, Malaga Auditorium (Hall 5)

    Discussion Time: 8:55-9:10 AM

Lung Cancer

  • Nivolumab (NIVO) + low-dose ipilimumab (IPI) vs platinum-doublet chemotherapy (chemo) as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (NSCLC): CheckMate 227 Part 1 final analysis

    Author: Peters

    Presentation Number: #LBA4_PR

    Session: Presidential Symposium I

    Session Time: Saturday, September 28, 4:30-6:20 PM, Barcelona Auditorium (Hall 2)

    Presentation Time: 5:32-5:44 PM
  • Impact of second-line (2L) immune checkpoint inhibitors (ICIs) on the treatment (Tx) of advanced non-small cell lung cancer (NSCLC) in a UK centre: a REAL-Oncology analysis from the I-O Optimise initiative

    Author: Snee

    Presentation Number: #1501P

    Session: Poster Display Session 1

    Session Time: Saturday, September 28, 12-1 PM, Poster Area (Hall 4)
  • Real-world effectiveness of nivolumab monotherapy after prior systemic therapy in advanced non-small cell lung cancer (NSCLC) in the United States

    Author: Stenehjem

    Presentation Number: #1498P

    Session: Poster Display Session 1

    Session Time: Saturday, September 28, 12-1 PM, Poster Area (Hall 4)
  • Nivolumab treatment in advanced non-small cell lung cancer (aNSCLC): a French nationwide retrospective cohort (UNIVOC Study)

    Author: Chouaid

    Presentation Number: #1281P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • IO-Synthesise NSCLC: A pooled analysis of real-world survival outcomes for non-small cell lung cancer patients treated with nivolumab in France and Germany

    Author: Dixmier

    Presentation Number: #1496P

    Session: Poster Display Session 1

    Session Time: Saturday, September 28, 12-1 PM, Poster Area (Hall 4)
  • Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: Updated survival and subgroup analysis from the real-world EVIDENS study

    Author: Barlesi

    Presentation Number: #1494P

    Session: Poster Display Session 1

    Session Time: Saturday, September 28, 12-1 PM, Poster Area (Hall 4)

Gastrointestinal Cancer

  • Nivolumab versus chemotherapy in patients with previously treated advanced esophageal squamous cell carcinoma: the ATTRACTION-3 trial

    Author: Cho

    Presentation Number: #LBA11

    Session: Presidential Symposium III

    Session Time: Monday, September 30, 4:30-6:15 PM, Barcelona Auditorium (Hall 2)

    Presentation Time: 4:42-4:54 PM
  • CheckMate 459: a randomized, multi-center phase 3 study of nivolumab (NIVO) versus sorafenib (SOR) as first-line treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC)

    Author: Yau

    Presentation Number: #LBA38_PR

    Session: Profferred Paper 1 – Gastrointestinal tumours, non-colorectal

    Session Time: Friday, September 27, 2-3:30 PM, Madrid Auditorium (Hall 2)

    Presentation Time: 2-2:15 PM

Cervical Cancer

  • Efficacy and safety of nivolumab (Nivo) + ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: Results from CheckMate 358

    Author: Oaknin

    Presentation Number: #LBA62

    Session: Profferred Paper 2 – Gynaecological cancers

    Session Time: Sunday, September 29, 8:30-10 AM, Madrid Auditorium (Hall 2)

    Presentation Time: 9:15-9:30 AM

Translational Medicine and Early Assets

  • Clinical and analytical accuracy of a 523 gene panel next-generation sequencing (NGS) assay on formalin-fixed paraffin-embedded (FFPE) solid tumor samples

    Author: Deras

    Presentation Number: #1410P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, Poster Display: 12-1 PM, Poster Area (Hall 4)
  • Microsatellite Instability Testing and Lynch Syndrome Screening For Colorectal Cancer Patients Through Tumor Sequencing

    Author: Liu

    Presentation Number: #1406P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, Poster Display: 12-1 PM, Poster Area (Hall 4)
  • Interferon ɣ (IFN-ɣ) gene signature and tryptophan 2,3-dioxygenase 2 (TDO2) gene expression: a potential predictive composite biomarker for linrodostat mesylate (BMS-986205; indoleamine 2,3-dioxygenase 1 inhibitor [IDO1i]) + nivolumab (NIVO)

    Author: Luke

    Presentation Number: #1874O

    Session: Proffered Paper – Translational research

    Session Time: Saturday, September 28, 8:30-10 AM, Pamplona Auditorium (Hall 2)

    Presentation Time: 9:15-9:30 AM
  • Comparison of platforms for determining tumor mutational burden (TMB) in patients with non-small cell lung cancer (NSCLC)

    Author: Baden

    Presentation Number: #90PD

    Session: Poster Discussion 1 – Translational research

    Session Time: Sunday, September 29, 8:45-9:45 AM, Salamanca Auditorium (Hall 3)

    Discussion Time: 9:15-9:35 AM
  • Comparison of platforms for determining tumor mutational burden (TMB) from blood samples in patients with non-small cell lung cancer (NSCLC)

    Author: Baden

    Presentation Number: #99P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Multiplex chromogenic immunohistochemistry (IHC) for spatial analysis of checkpoint-positive tumor infiltrating lymphocytes (TILs)

    Author: Ely

    Presentation Number: #128P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Radiomic signatures for identification of tumors sensitive to nivolumab or docetaxel in squamous non-small cell lung cancer (sqNSCLC)

    Author: Dercle

    Presentation Number: #1910P

    Session: Poster Display Session 3

    Session Time: Monday, September 30, 12-1 PM, Poster Area (Hall 4)
  • Cell phenotypes associated with response and toxicity defined by high resolution flow cytometry in melanoma patients receiving checkpoint inhibition

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