Bristol Myers Squibb Research at ESMO Virtual Congress 2020 Highlights Significant Progress in Cancers with High Unmet Medical Need
September 8, 2020Late-breaking data from pivotal Phase 3 CheckMate -577 and CheckMate -649 trials to be featured in ESMO Presidential Symposium III and highlight potential for Opdivo (nivolumab) and Opdivo-based regimens to change standard of care in early and advanced stages of certain esophageal and gastric cancers
Detailed results from CheckMate -9ER, presented in partnership with Exelixis, Inc. and featured in ESMO Presidential Symposium I, and four-year follow-up data from CheckMate -214 underscore the potential of Opdivo-based combinations to significantly improve survival among patients with advanced renal cell carcinoma
Late-breaking patient-reported outcomes from CheckMate -9LA examine impact of Opdivo plus Yervoy (ipilimumab) combined with limited chemotherapy on health-related quality of life in patients with metastatic non-small lung cancer (NSCLC)
Bristol Myers Squibb to Host Virtual Investor Event on Sept 21 to Discuss ESMO Highlights
PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE:BMY) today announced the presentation of research spanning 15 different cancers at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020, reinforcing the depth and breadth of its oncology development program, leadership in immuno-oncology and commitment to delivering value to patients and health systems by discovering potential options to improve long-term outcomes in cancer patients. The virtual congress will take place from September 19 to 21, 2020.
Presentations will highlight Bristol Myers Squibb’s research aimed at addressing cancer through clinical data evaluating Opdivo (nivolumab) as an adjuvant therapy, Opdivo plus Yervoy (ipilimumab) as a first-line treatment and Opdivo-based combinations across an expanding range of cancer types with the goal of advancing durable therapeutic outcomes for patients in need.
Bristol Myers Squibb will also present data exploring various novel tumor targets in early-stage pipeline therapies and novel combinations in cancers including non-Hodgkin lymphoma, extensive-stage small cell lung cancer, diffuse large B-cell lymphoma and glioblastoma, and nearly 20 presentations will share health economic and real-world research on the clinical and economic impact of Bristol Myers Squibb’s therapies.
Overall, data from more than 67 company-sponsored studies will be presented at the meeting, including 12 late-breaking abstracts and 14 proffered paper presentations. The volume and diversity of these data highlight the role of Bristol Myers Squibb as a company dedicated to transforming the lives of patients with different types of cancer through science.
Key data being presented by Bristol Myers Squibb and its partners at the ESMO Virtual Congress 2020 include:
Renal Cell Carcinoma
- First disclosure of detailed Phase 3 CheckMate -9ER efficacy and safety results for Opdivo in combination with Exelixis’ CABOMETYX® (cabozantinib) versus sunitinib in previously untreated advanced renal cell carcinoma (RCC); CheckMate -9ER results will be featured as part of an ESMO Presidential Symposium and in the official Press Programme. (Read more…)
- Four-year follow-up from Phase 3 CheckMate -214 study of Opdivo plus Yervoy compared with sunitinib in patients with previously untreated advanced or metastatic RCC; CheckMate -214 represents longest follow-up from a Phase 3 trial of an immunotherapy-based combination in previously untreated advanced RCC.
Gastrointestinal Cancers
- First disclosure of Phase 3 CheckMate -577 disease-free survival results for adjuvant Opdivo versus placebo for patients with resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy; CheckMate -577 results will be featured as part of an ESMO Presidential Symposium and in the official Press Programme.
- First disclosure of Phase 3 CheckMate -649 overall survival and progression-free survival results for Opdivo plus chemotherapy compared with chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma; CheckMate -649 results will be featured as part of an ESMO Presidential Symposium and in the official Press Programme.
Lung Cancer
- Patient-reported outcomes on health-related quality of life from the Phase 3 CheckMate –9LA trial of Opdivo plus Yervoy in combination with two cycles of chemotherapy versus chemotherapy in patients with metastatic advanced non-small cell lung cancer (NSCLC).
- Analyses in Asian patients with advanced NSCLC from both CheckMate –9LA and CheckMate-227, which investigated Opdivo plus Yervoy in combination with two cycles of chemotherapy versus chemotherapy and Opdivo plus Yervoy versus chemotherapy as a first-line treatment, respectively.
Melanoma
- Four-year results from CheckMate -238 evaluating Opdivo versus Yervoy in adjuvant melanoma and five-year characterizations of complete responses from CheckMate -066, CheckMate -067 and CheckMate -069 studies evaluating Opdivo plus Yervoy or Opdivo alone in advanced melanoma.
“Bristol Myers Squibb has made important progress in demonstrating the significant impact our treatments can have on long-term survival and patient outcomes in numerous cancers,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “New data we are presenting at ESMO will highlight the potential to change the standard of care for certain cancers, demonstrate the value our therapies can bring to patients, and showcase how we are defining the future of medicine. We are also grateful for the tireless support from and collaboration with the cancer community, especially from investigators and patients, without whom our research would not be possible.”
Virtual Investor Event
Bristol Myers Squibb will host a virtual Investor Event on Monday, September 21, 2020 at 4:30 p.m. EDT to discuss data presented at the European Society of Medical Oncology (ESMO). Company executives will provide an overview of data presented and address questions from investors and analysts.
Investors and the general public are invited to listen to a live webcast at http://investor.bms.com or by calling the U.S. toll free at 800-289-0571 or international +1 313-209-6672, confirmation code: 7966221, or using this link, which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Materials related to the webcast will be available at the same website prior to the event. An archived edition of the session will be available later that day.
Select Bristol Myers Squibb studies at the ESMO Virtual Congress 2020 include:
*All times noted are Central European Summer Time (CEST)
Gastrointestinal
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Nivolumab (NIVO) plus chemotherapy (CT) versus CT in first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): first results of the CheckMate 649 study
Author: M. Moehler
Abstract: #LBA6
Presidential Symposium III, Channel 1
Presentation Time: Monday, September 21, 18:30-18:42 CEST
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Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiation therapy (CRT): first results of the CheckMate 577 study
Author: R. J. Kelly
Abstract: #LBA9
Presidential Symposium III, Channel 1
Presentation Time: Monday, September 21, 19:31-19:43 CEST
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A nationwide population-based study comparing treatment patterns and outcomes in synchronous versus metachronous metastatic esophageal and gastric adenocarcinoma
Author: M. Pape
Abstract: #1465P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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The humanistic burden reported by patients with unresectable locally advanced or metastatic (adv/met) Gastric Cancer (GC), Gastroesophageal Junction Cancer (GEJC) and Esophageal Adenocarcinoma (EAC): An international real-world survey
Author: J. Hall
Abstract: #1469P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Impact on work productivity in unresectable locally advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma patients and their caregivers
Author: H. Xiao
Abstract: #1433P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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The experience associated with caregiving for patients with intermediate stage hepatocellular carcinoma (HCC) receiving transcatheter arterial chemoembolisation (TACE) treatment
Author: J. Edeline
Abstract: #1011P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
Genitourinary
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Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: first results from the randomized phase 3 CheckMate 9ER trial
Author: T. K. Choueiri
Abstract: #696O
Presidential Symposium I, Channel 1
Presentation Time: Saturday, September 19, 19:34-19:46 CEST
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Nivolumab + ipilimumab (N+I) vs sunitinib (S) for first-line treatment of advanced renal cell carcinoma (aRCC) in CheckMate 214: 4-year follow-up and subgroup analysis of patients (pts) without nephrectomy
Author: L. Albiges
Abstract: #711P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Nivolumab (N) alone or in combination with ipilimumab (I) in patients (pts) with platinum-pretreated metastatic urothelial carcinoma (mUC): extended follow-up from CheckMate 032
Author: P. Sharma
Abstract: #749P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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A phase 3, randomized, double-blind trial of nivolumab or placebo combined with docetaxel for metastatic castration-resistant prostate cancer (mCRPC; CheckMate 7DX)
Author: C. G. Drake
Abstract: #690TiP
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Treatment-free survival, with and without toxicity, after immuno-oncology vs targeted therapy for advanced renal cell carcinoma (aRCC): 42-month results of CheckMate 214
Author: M. Regan
Abstract: #713P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Time to deterioration in quality of life in previously untreated patients with advanced renal cell carcinoma (aRCC) in CheckMate 214
Author: D. Cella
Abstract: #714P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Comparison of long-term survival and cost-effectiveness (CE) of first-line (1L) treatment options in advanced renal cell carcinoma (aRCC) with intermediate or poor (I/P) prognostic risk
Author: T. K. Choueiri
Abstract: #717P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
Lung Cancer
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First-line nivolumab (NIVO) + ipilimumab (IPI) in combination with 2 cycles of platinum-based chemotherapy (chemo) vs 4 cycles of chemo in advanced non-small cell lung cancer (NSCLC): Patient-reported outcomes (PROs) from CheckMate 9LA
Author: M. Reck
Abstract: #LBA59
Mini Oral Session: NSCLC, metastatic
Presentation Time: Friday, September 18 (On-Demand)
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First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) + chemotherapy (chemo) in Asian patients (pts) with advanced non-small cell lung cancer (NSCLC) from CheckMate 9LA
Author: T. John
Abstract: #1311P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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First-line (1L) nivolumab (NIVO) plus ipilimumab (IPI) in Asian patients with advanced non-small cell lung cancer (aNSCLC) in CheckMate 227
Author: K. O’Byrne
Abstract: #1274P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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CheckMate 73L: A phase 3 study comparing nivolumab (NIVO) plus concurrent chemoradiotherapy (CCRT) followed by NIVO ± ipilimumab (IPI) versus CCRT followed by durvalumab (DURV) for previously untreated, locally advanced (LA) stage III non-small cell lung cancer (NSCLC)
Author: D. De Ruysscher
Abstract: #1255TiP
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Trial-based costs of all-cause adverse events in first-line therapy for advanced non-small-cell lung cancer: findings from CheckMate-227
Author: S. Lubinga
Abstract: #1282P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Trial-based costs of all-cause adverse events in first-line therapy for advanced non-small-cell lung cancer: findings from CheckMate-9LA
Author: D. Stenehjem
Abstract: #1316P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Pathologic response as early endpoint for survival following neoadjuvant therapy (NEO-AT) in resectable non-small cell lung cancer (rNSCLC): Systematic literature review and meta-analysis
Author: N. Waser
Abstract: #1243P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Nivolumab treatment in advanced non-small cell lung cancer (aNSCLC): real-world 3-year outcomes within overall and special populations (the UNIVOC study)
Author: J. Assié
Abstract: #1276P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Long-term survival and health-related quality of life in patients treated with nivolumab for advanced non-small cell lung cancer: a wide prospective French real-world study (EVIDENS)
Author: F. Barlesi
Abstract: #1325P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Integrating patients’ quality of life (QoL) into clinical practice: a Delphi method-based consensus among French physicians managing lung cancer patients
Author: V. Westeel
Abstract: #1569P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Treatment patterns and outcomes in malignant pleural mesothelioma (MPM) in England: A nationwide CAS registry analysis from the I-O Optimise initiative
Author: P. Baas
Abstract: #1909P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
Melanoma
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Adjuvant nivolumab (NIVO) vs ipilimumab (IPI) in resected stage III/IV melanoma: 4-yr recurrence-free and overall survival (OS) results from CheckMate 238
Author: J. Weber
Abstract: #1076O
Proffered Paper Session: Melanoma and Other Skin Tumours, Channel 2
Presentation Time: Saturday, September 19, 17:28-17:40 CEST
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5-year characterization of complete responses in patients with advanced melanoma who received nivolumab plus ipilimumab (NIVO+IPI) or NIVO alone
Author: C. Robert
Abstract: #1082MO
Mini Oral Session: Melanoma and Other Skin Tumours
Presentation Time: Friday, September 18 (On-Demand)
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Nivolumab (NIVO) monotherapy or combination therapy with ipilimumab (NIVO+IPI) in advanced melanoma patients with brain metastases: real-world evidence from the German non-interventional study NICO
Author: R. Gutzmer
Abstract: #1104P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
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Estimating long-term survivorship in patients with advanced melanoma treated with immune-checkpoint inhibitors: analyses from the phase 3 CheckMate 067 trial
Author: P. Mohr
Abstract: #1105P
E-Poster Display ( Presentation Time: Thursday, September 17 (On-Demand)
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Long-Term Outcomes of Stage IIB-IV Melanoma Patients: Nationwide Data From Norway
Author: A. Winge-Main
Abstract: #1150P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
Early Assets
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CC-90010, a reversible, oral bromodomain and extra-terminal (BET) inhibitor in patients (pts) with advanced solid tumors (STs) and relapsed/refractory (R/R) non-Hodgkin lymphoma: updated results of a phase 1 study
Author: V. Moreno
Abstract: #527O
Proffered Paper Session: Developmental Therapeutics, Channel 3
Presentation Time: Sunday September 20, 17:16-17:28 CEST
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CC-90011 in patients (Pts) with advanced solid tumors (STs) and relapsed/refractory non-Hodgkin lymphoma (R/R NHL): updated results of a phase I study
Author: A. Hollebecque
Abstract: #5280
Proffered Paper Session: Developmental Therapeutics, Channel 3
Presentation Time: Sunday, September 20, 17:28-17:40 CEST
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Phase 1b study of CC-90011 plus etoposide and cisplatin (EP) in patients with first-line extensive-stage (ES) small cell lung cancer (SCLC)
Author: L. Paz-Ares
Abstract: #559P
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
Safety
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Pan-Tumor Study CheckMate 8TT for Long-term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab
Author: C. Denlinger
Abstract: #1155TiP
E-Poster Display
Presentation Time: Thursday, September 17 (On-Demand)
Bristol Myers Squibb: Advancing Cancer Research
At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.
Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines 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.
INDICATIONS
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), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
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.
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