On August 30, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported more than 60 presentations, including seven late-breaking abstracts, from its Oncology portfolio will be featured at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain, September 8-12 (Press release, Bristol-Myers Squibb, AUG 30, 2017, View Source [SID1234520340]). Presentations of data from company-sponsored studies, clinical collaborations and investigator-sponsored research will explore the potential role of Opdivo (nivolumab) as monotherapy and in combination with Yervoy (ipilimumab); with relatlimab (formerly known as BMS-986016), a fully human monoclonal antibody that targets lymphocyte activation gene-3 (LAG-3); or with chemotherapy in 13 types of cancer and analyses that provide insights into the potential role of biomarkers to predict patients’ treatment response.
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Presentations that illustrate the company’s approach include the following:
Late-breaking research to be featured in Presidential Symposia from CheckMate -238 evaluating the safety and efficacy of adjuvant Opdivo in resected high-risk melanoma, and from CheckMate -214 on Opdivo in combination with Yervoy in previously untreated advanced renal cell carcinoma.
Additional late-breaking presentations featuring the first disclosures of data on Opdivo in advance of surgery in squamous cell cancer of the head and neck, from CheckMate -358, and for Opdivo following induction treatment in triple-negative breast cancer.
Late-breaking updated efficacy results from an ongoing study of relatlimab in combination with Opdivo in patients with melanoma who progressed during prior anti-PD-1/PD-L1 therapy in all-comer and biomarker-enriched populations.
Analyses of emerging biomarkers, including tumor mutation burden, microsatellite instability, LAG-3, T cell infiltration and immune cell profiles, that may help inform more precise treatment approaches. Data on the clinical impact of a fixed duration of Opdivo in non-small cell lung cancer from CheckMate -153 will also be presented.
Additional data evaluating Opdivo-based combinations that are rationally designed based on BMS’ deep understanding of cancer biology, including studies of Opdivo in combination with Yervoy, and the first disclosure of data from ONO-37 on the safety and clinical activity of Opdivo in combination with chemotherapy in previously untreated gastric/gastroesophageal junction cancer.
The full set of data from research investigating the company’s I-O medicines includes the following:
Gastrointestinal Malignancies
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A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer: updated results and subset analysis by PD-L1 expression (ATTRACTION-02/ONO-4538-12)
Author: N. Boku
Abstract #617O
Proffered Paper Session: Gastrointestinal Tumors, Non-Colorectal 1
Friday, September 8, 2:51–3:03 PM CEST, Barcelona Auditorium
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Two-year survival and safety update for esophageal squamous cell carcinoma treated with nivolumab (ATTRACTION-01/ONO-4538-07)
Author: Y. Kitagawa
Abstract #638P
Poster Display Session
Saturday, September 9, 1:15–2:15 PM CEST, Hall 8
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Interim safety and clinical activity of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated unresectable advanced or recurrent gastric/gastroesophageal junction cancer: part 1 study of ATTRACTION-04/ONO-4538-37
Author: Y-K. Kang
Abstract #671P
Poster Display Session
Saturday, September 9, 1:15–2:15 PM CEST, Hall 8
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Nivolumab in patients with advanced chemotherapy-refractory esophagogastric cancer according to microsatellite instability status: CheckMate -032
Author: P. Ott
Abstract #674P
Poster Display Session
Saturday, September 9, 1:15–2:15 PM CEST, Hall 8
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ATTRACTION-04/ONO-4538-37: A randomized, multicenter, phase 2/3 study of nivolumab plus chemotherapy in patients with previously untreated advanced or recurrent gastric or gastroesophageal junction cancer
Author: L.-T. Chen
Abstract #777TiP
Poster Display Session
Saturday, September 9, 1:15–2:15 PM CEST, Hall 8
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ATTRACTION-05/ONO-4538-38/BMS CA209844: A randomized, multicenter, double-blind, placebo- controlled phase 3 study of nivolumab in combination with adjuvant chemotherapy in Stage III gastric and esophagogastric junction cancer
Author: M. Terashima
Abstract #778TiP
Poster Display Session
Saturday, September 9, 1:15–2:15 PM CEST, Hall 8
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Real-world productivity, healthcare resource utilization, and quality of life in patients with advanced gastric cancer in Canada and Europe
Author: G. Maglinte
Abstract #1112PD
Poster Discussion Session: Public Health Policy and Health Economics
Saturday, September 9, 4:30–5:45 PM CEST, Tarragona Auditorium
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Analysis of tumor PD-L1 expression and biomarkers in relation to clinical activity in patients with deficient DNA mismatch repair/high microsatellite instability metastatic colorectal cancer treated with nivolumab + ipilimumab: CheckMate -142
Author: T. André
Abstract #484PD
Poster Discussion Session: Gastrointestinal Tumors, Colorectal
Sunday, September 10, 3–4 PM CEST, Sevilla Auditorium
Genitourinary Cancer
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Medical costs and health care resource use in elderly U.S. patients with newly diagnosed metastatic or surgically unresectable urothelial carcinoma using Surveillance, Epidemiology, and End Results (SEER) Medicare data
Author: A. Aly
Abstract #1131P
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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A phase 3, randomized, double-blind, multicenter study of adjuvant nivolumab vs placebo in patients with high-risk invasive urothelial carcinoma (CheckMate -274)
Author: D. Bajorin
Abstract #921TiP
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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Impact of tumor mutation burden on nivolumab efficacy in second-line urothelial carcinoma patients: exploratory analysis of the phase 2 CheckMate -275 study
Author: M. Galsky
Abstract #848PD
Poster Discussion Session: Genitourinary Tumors, Non-Prostate
Sunday, September 10, 2:45–4:15 PM CEST, Cordoba Auditorium
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Epithelial-mesenchymal transition, T cell infiltration, and outcomes with nivolumab in urothelial cancer
Author: M. Galsky
Abstract #850PD
Poster Discussion Session: Genitourinary Tumors, Non-Prostate
Sunday, September 10, 2:45–4:15 PM CEST, Cordoba Auditorium
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CheckMate -214: Efficacy and safety of nivolumab + ipilimumab v sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups
Author: B. Escudier
Abstract #LBA5
Presidential Symposium II
Sunday, September 10, 4:30–6:20 PM CEST, Madrid Auditorium
Glioblastoma
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Nivolumab in combination with radiotherapy ± temozolomide: updated safety results from CheckMate -143 in patients with methylated or unmethylated newly diagnosed glioblastoma
Author: M. Lim
Abstract #325O
Proffered Paper Session: CNS Tumors
Friday, September 8, 4–4:12 PM CEST, Alicante Auditorium
Head and Neck Cancer
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An open-label, multicohort, phase 1/2 study in patients with virus-associated cancers (CheckMate -358): safety and efficacy of neoadjuvant nivolumab in squamous cell carcinoma of the head and neck
Author: R. Ferris
Abstract #LBA46
Poster Discussion Session: Head and Neck Cancer
Saturday, September 9, 2:45–4:15 PM CEST, Alicante Auditorium
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Nivolumab vs investigator’s choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: treatment effect on clinical outcomes by best overall response in CheckMate -141
Author: L. Licitra
Abstract #1055P
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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Estimated costs of treatment-related adverse events for recurrent or metastatic squamous cell carcinoma of the head and neck in the CheckMate -141 trial
Author: M. Venkatachalam
Abstract #1056P
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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Treatment beyond progression with nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck in the phase 3 CheckMate -141 study: a biomarker analysis and updated clinical outcomes
Author: R. Haddad
Abstract #1043O
Proffered Paper Session: Head and Neck Cancer
Monday, September 11, 3:12–3:24 PM CEST, Granada Auditorium
Melanoma
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Characterization of complete responses in patients with advanced melanoma who received the combination of nivolumab and ipilimumab, nivolumab or IPI alone
Author: C. Robert
Abstract #1213O
Proffered Paper Session: Melanoma and Other Skin Tumors
Saturday, September 9, 2:45–3 PM CEST, Madrid Auditorium
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Cost-effectiveness of nivolumab + ipilimumab in first-line treatment of advanced melanoma: analysis using 28-month overall survival from CheckMate -067
Author: J. Sabater
Abstract #1115P
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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Late physical, psychological and social consequences of ipilimumab treatment in advanced melanoma
Author: A. Boekhout
Abstract #1260TiP
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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Real-world use of ipilimumab and nivolumab monotherapy or in combination in patients with advanced melanoma: results from a retrospective chart review
Author: A. Tarhini
Abstract #1250P
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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Regional differences in overall survival in patients with advanced melanoma who received nivolumab combined with ipilimumab or nivolumab alone in a phase 3 trial (CheckMate -067)
Author: J.-J. Grob
Abstract #1222PD
Poster Discussion Session: Melanoma and Other Skin Tumors
Monday, September 11, 11 AM–12:15 PM CEST, Pamplona Auditorium
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Quality-adjusted survival of combined nivolumab plus ipilimumab or NIVO alone vs IPI among treatment-naïve patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis
Author: M. Botteman
Abstract #1223PD
Poster Discussion Session: Melanoma and Other Skin Tumors
Monday, September 11, 11 AM–12:15 PM CEST, Pamplona Auditorium
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Adjuvant therapy with nivolumab versus ipilimumab after complete resection of Stage III/IV melanoma: a randomized, double-blind, phase 3 trial (CheckMate -238)
Author: J. Weber
Abstract #LBA8
Presidential Symposium III
Monday, September 11, 5:15–5:30 PM CEST, Madrid Auditorium
Thoracic Malignancies
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Randomized results of fixed-duration (1-yr) vs continuous nivolumab in patients with advanced non-small cell lung cancer
Author: D. Spigel
Abstract #1297O
Proffered Paper Session: NSCLC, Metastatic 1
Friday, September 8, 4:39–4:51 PM CEST, Madrid Auditorium
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Efficiency of nivolumab in the treatment of second-line advanced non-squamous non-small cell lung cancer in Spain
Author: P. González
Abstract #1319P
Poster Display Session
Saturday, September 9, 1:15–2:15 PM CEST, Hall 8
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Three-year follow-up from CheckMate -017/-057: nivolumab versus docetaxel in patients with previously treated advanced non-small cell lung cancer
Author: E. Felip
Abstract #1301PD
Poster Discussion Session: NSCLC, Metastatic
Sunday, September 10, 4:30–6 PM CEST, Barcelona Auditorium
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Nivolumab in previously treated patients with metastatic squamous NSCLC: results of a European single-arm, phase 2 trial (CheckMate -171) including patients aged ≥70 years and with poor performance status
Author: S. Popat
Abstract #1303PD
Poster Discussion Session: NSCLC, Metastatic
Sunday, September 10, 4:30–6 PM CEST, Barcelona Auditorium
Early Assets & Cross-tumor
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Impact of licensing and reimbursement discrepancies on patient access to cancer treatments across Europe and Canada
Author: J. McKendrick
Abstract #1124P
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8
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Anti-CC-chemokine receptor 4 (CCR4) antibody mogamulizumab and nivolumab combination phase 1 study in patients with advanced or metastatic solid tumors
Author: N. Yamamoto
Abstract #LBA17
Proffered Paper Session: Developmental Therapeutics
Sunday, September 10, 4:30–4:45 PM CEST, Cordoba Auditorium
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Efficacy of BMS-986016, a monoclonal antibody that targets lymphocyte activation gene-3 (LAG-3), in combination with nivolumab in patients with melanoma who progressed during prior anti–PD-1/PD-L1 therapy in all-comer and biomarker-enriched populations
Author: P. Ascierto
Abstract #LBA18
Proffered Paper Session: Developmental Therapeutics
Sunday, September 10, 4:45–5 PM CEST, Cordoba Auditorium
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Initial results of BMS-986012, a first-in-class fucosyl-GM1 mAb, in combination with nivolumab, in patients with relapsed/refractory small-cell lung cancer
Author: Q. Chu
Abstract #1528PD
Poster Discussion Session: Non-metastatic NSCLC and Other Thoracic Malignancies
Monday, September 11, 2:45–4:15 PM CEST, Pamplona Auditorium
Clinical Collaborations
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A phase 1/2 study on safety of rovalpituzumab tesirine in combination with nivolumab or nivolumab + ipilimumab in small cell lung cancer
Author: C. Scripture
Abstract #1538TiP
Poster Display Session
Saturday, September 9, 1:15–2:15 PM CEST, Hall 8
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PIVOT-02: A phase 1/2, open-label, multicenter, dose escalation and dose expansion study of NKTR-214 and nivolumab in patients with select, locally advanced or metastatic solid tumor malignancies
Author: A. Diab
Abstract #1212TiP
Poster Display Session
Sunday, September 10, 1:15–2:15 PM CEST, Hall 8