New Research From Bristol-Myers Squibb at ESMO 2016 Congress Reinforces Leadership in Immuno-Oncology and Differentiated Research Approach

On October 3, 2016 Bristol-Myers Squibb Company (NYSE:BMY) reported new data across eight tumor types evaluating Opdivo (nivolumab) and Yervoy (ipilimumab), as monotherapy or in combination, as well as new assets, to be presented at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Copenhagen, Denmark from October 7–11 (Press release, Bristol-Myers Squibb, OCT 3, 2016, View Source [SID:SID1234515557]). Data presented at this congress underscore the Company’s commitment to its portfolio and to discover the next wave of transformational Immuno-Oncology medicines, including combination therapies, for difficult-to-treat cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Bristol-Myers Squibb continues to lead the scientific understanding of Immuno-Oncology with an extensive portfolio and a differentiated clinical development program where we have set a high bar of success to look for clear and differentiated improvements over currently available therapies," said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. "We remain focused on expanding the use of the Opdivo and Yervoy combination to more tumors, and bringing forward novel agents and combination regimens in earlier lines of therapy, to help even more patients with cancer."

Bristol-Myers Squibb assets featured in a total of 26 data presentations. A select listing of Presidential Symposia and oral abstract sessions is included below:

CheckMate -064: Baseline tumor T cell receptor sequencing analysis and neo-antigen load is associated with response and survival in melanoma patients receiving sequential Opdivo and Yervoy (Abstract #1047O). Data will be presented during an oral proferred paper session on Friday, October 7 at 4:45 – 5:00 p.m. CEST.
CheckMate -275: First disclosure of efficacy and safety of Opdivo monotherapy in patients with metastatic urothelial cancer who have received prior treatment (Abstract #LBA31_PR). Data will be presented during an oral proffered paper session on Saturday, October 8 at 9:15 – 9:30 a.m. CEST.
CA184-169: First disclosure of overall survival and safety data from a Phase 3 trial evaluating Yervoy at 3 mg/kg vs. 10 mg/kg in patients with metastatic melanoma (Abstract #1106O). Data will be presented during an oral proffered paper session on Saturday, October 8 at 3:37 – 3:50 p.m. CEST.
CA184-029 (EORTC 18071): Initial report of survival data from a Phase 3 trial evaluating Yervoy versus placebo after complete resection of stage III melanoma (Abstract #LBA2_PR). Data will be featured during the ESMO (Free ESMO Whitepaper) Press Program on Saturday, October 8 at 8:15 a.m. CEST and presented during a Presidential Symposium at 5:00 – 5:15 p.m. CEST.
CheckMate -040: Interim analysis of a Phase 1/2 study evaluating the safety and preliminary efficacy of Opdivo in patients with advanced hepatocellular carcinoma (Abstract #615O). Data will be presented during an oral proffered paper session on Sunday, October 9 at 12:00 – 12:15 p.m. CEST.
CheckMate -141: Evaluation of patient-reported outcomes data in recurrent or metastatic squamous cell carcinoma of the head and neck treated with Opdivo or investigator’s choice (Abstract #LBA4_PR). Data will be presented during a Presidential Symposium on Sunday, October 9 at 4:25 – 4:40 p.m. CEST.
CheckMate -026: Phase 3 trial of Opdivo versus investigator’s choice of platinum-based doublet chemotherapy as first-line therapy for stage IV/recurrent PD-L1 positive non-small cell lung cancer (Abstract #LBA7_PR). Data will be presented during a Presidential Symposium on Sunday, October 9 at 5:35 – 5:50 p.m. CEST.
The full set of data to be presented by Bristol-Myers Squibb include:

Bladder

CheckMate -275: Efficacy and safety of nivolumab monotherapy in patients with metastatic urothelial cancer who have received prior treatment; results from the phase 2 study

Author: Galsky
Abstract # LBA31_PR
Proffered Paper Session, Genitourinary Tumors, Non-Prostate
Saturday, October 8, 2016, 9:15 – 9:30 a.m. CEST, Madrid

CheckMate -032: Nivolumab monotherapy in metastatic urothelial cancer: Updated efficacy by subgroups and safety results

Author: J. Rosenberg
Abstract #784P
Poster Session, Genitourinary Tumours, Non-Prostate
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Colorectal

CheckMate -142: Nivolumab ± ipilimumab treatment efficacy, safety, and biomarkers in patients with metastatic colorectal cancer with and without high microsatellite instability

Author: M. Overman
Abstract #479P
Poster Session, Gastrointestinal Tumours, Colorectal
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Glioblastoma

CheckMate -548: A randomized phase 2, single-blind study of temozolomide and radiotherapy combined with nivolumab or placebo in newly diagnosed adult patients with tumor O6-methylguanine DNA methyltransferase-methylated glioblastoma

Author: M. Weller
Abstract # 356TiP
Poster Session, CNS Tumors
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Head and Neck

Safety of the natural killer cell-targeted anti-KIR antibody, lirilumab, in combination with nivolumab or ipilimumab in two phase 1 studies in advanced refractory solid tumors

Author: N. Segal
Abstract #1086P
Poster Session, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -651: A randomized, open-label, phase 3 study of nivolumab in combination with ipilimumab vs extreme regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as first-line therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Author: A. Argiris
Abstract #1016TiP
Poster Session, Head and Neck Cancer
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -714: Double-blind, two-arm, phase 2 study of nivolumab in combination with ipilimumab versus nivo and ipi-placebo as first-line therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Author: R. Haddad
Abstract #1017TiP
Poster Session, Head and Neck Cancer
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -141: Evaluation of patient-reported outcomes data in recurrent or metastatic squamous cell carcinoma of the head and neck treated with nivolumab or investigator’s choice

Author: K. Harrington
Abstract # LBA4_PR
Presidential Symposium 2
Sunday, October 9, 2016, 4:25 – 4:40 p.m. CEST, Copenhagen

Hepatocellular Carcinoma

CheckMate -040: Safety and preliminary efficacy of nivolumab in patients with advanced hepatocellular carcinoma: Phase 1/2 interim analysis

Author: I. Melero
Abstract # 615O
Proffered Paper, Gastrointestinal Tumors, Non-Colorectal 2
Sunday, October 9, 2016, 12:00 – 12:15 p.m. CEST, Vienna

Lung

CheckMate -017 and -057: Healthcare resource utilization in patients with advanced non-small cell lung cancer based on treatment-related adverse events

Author: M. Venkatachalam
Abstract #1220P
Poster Session, NSCLC, Metastatic
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Cost of care in first line advanced non-small cell lung cancer patients: Chemotherapy vs. targeted therapy

Author: J. Radtchenko
Abstract #1273P
Poster Session, NSCLC, Metastatic
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

FRACTION-Lung: A phase 2, fast real-time assessment of combination therapies in immuno-oncology trial in patients with advanced non-small cell lung cancer

Author: P. Fracasso
Abstract #1295TiP
Poster Session, NSCLC, Metastatic
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

The humanistic burden of small cell lung cancer: A systematic review of health-related quality of life literature

Author: C. Panter
Abstract: #1429P
Poster Session, SCLC
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -017 and CheckMate -057: Long-term outcomes with nivolumab versus docetaxel in patients with advanced non-small cell lung cancer: two-year update

Author: F. Barlesi
Abstract #1215PD
Poster Discussion, NSCLC, Metastatic
Sunday, October 9, 2016, 2:45 – 4:15 p.m. CEST (3:46 – 4:06 p.m. CEST), Oslo

CheckMate -057: Overall health status in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel

Author: M. Reck
Abstract #1217PD
Poster Discussion, NSCLC, Metastatic
Sunday, October 9, 2016, 2:45 – 4:15 p.m. CEST (3:46 – 4:06 p.m. CEST), Oslo

A phase 1/2 trial of a monoclonal antibody targeting fucosyl GM1 in relapsed/refractory small cell lung cancer: Safety and preliminary efficacy

Author: Q. Chu
Abstract #1427PD
Poster Discussion, Non-Metastatic NSCLC and Other Thoracic Malignancies
Monday, October 10, 2016, 3:00 – 4:00 p.m. CEST (3:20 – 3:30 p.m. CEST), Berlin

CheckMate -026: A phase 3 trial of nivolumab vs investigator’s Choice of platinum-based doublet chemotherapy as first-line therapy for stage IV/recurrent programmed death ligand 1−positive non-small cell lung cancer

Author: M. Socinski
Abstract #LBA7_PR
Presidential Symposium 2
Sunday, October 9, 2016, 5:35 – 5:50 p.m. CEST, Copenhagen

Melanoma

Baseline tumor T cell receptor sequencing analysis and neo antigen load is associated with benefit in melanoma patients receiving sequential nivolumab and ipilimumab

Author: J. Weber
Abstract #1047O
Proffered Paper, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Friday, October 07, 2016, 4:45 – 5:00 p.m. CEST, Copenhagen

Overall survival and safety results from a phase 3 trial of ipilimumab at 3 mg/kg vs. 10 mg/kg in patients with metastatic melanoma

Author: P. Ascierto
Abstract #1106O
Proffered Paper, Melanoma and Other Skin Tumors
Saturday, October 8, 2016, 3:37 – 3:50 p.m. CEST, Copenhagen

Ipilimumab vs. placebo after complete resection of stage III melanoma: final overall survival results from the EORTC 18071 randomized, double-blind, phase 3 trial

Author: L. Eggermont
Abstract #LBA2_PR
Presidential Symposium 1
Saturday, October 8, 2016, 5:00 – 5:15 p.m. CEST, Copenhagen

Safety profile of nivolumab and ipilimumab combination therapy in patients with advanced melanoma

Author: M. Sznol
Abstract #1123P
Poster Session, Melanoma And Other Skin Tumors
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Safety of reduced infusion times for nivolumab plus ipilimumab and nivolumab alone in advanced melanoma

Author: S. Martin-Algarra
Abstract #1125P
Poster Session, Melanoma and Other Skin Tumors
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

PD-L1 expression as a biomarker for nivolumab plus ipilimumab and nivolumab alone in advanced melanoma: A pooled analysis

Author: G. Long
Abstract #1112PD
Poster Discussion, Melanoma and Other Skin Tumors
Monday, October 10, 2016, 11:00 a.m. – 12:00 p.m. CEST (11:30 – 11:50 a.m. CEST), Rome

Renal Cell Carcinoma

Cost-effectiveness of nivolumab in patients with advanced renal cell carcinoma in Sweden

Author: S. Johal
Abstract #1032P
Poster Session, Health Economics
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -016: Updated results from a phase 1 study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma

Author: H. Hammers
Abstract #1062P
Poster Session, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Pan-Tumor

Assessment of nivolumab benefit-risk profile from a 240-mg flat dose versus a 3-mg/kg dosing regimen in patients with solid tumors

Author: X. Zhao
Abstract #1098P
Poster Session, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E