Long-term data continue to reinforce benefits of Opdivo (nivolumab)-based combinations
Response outcomes data continue to build upon the clinical evidence of Opdualag (nivolumab and relatlimab-rmbw) in advanced melanoma
Exploratory analyses in non-small cell lung cancer and urothelial carcinoma support the potential benefit of immunotherapy in earlier stages of cancer
PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #ESMO—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of scientific research across several solid tumors showcasing the breadth of the Company’s oncology development program at the European Society for Medical Oncology (ESMO) Congress 2022 from September 9-13 in Paris, France. Over 90 Bristol Myers Squibb-sponsored studies, investigator-sponsored studies, and collaborations will be presented at the Congress. Presentations will include data across our oncology portfolio, such as data that support the role of Opdivo-based approaches in earlier stages of cancer, reinforce the durable long-term survival and health-related quality of life benefits of Opdivo-based combinations, and further demonstrate the benefit of LAG-3 blocking antibody combinations in melanoma with Opdualag.
“Research at this year’s ESMO reinforces the depth and breadth of our development program, spanning from earlier to late stages of cancer. Our robust clinical research program and transformative science is helping to drive improved long-term outcomes for people living with cancer,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “We look forward to sharing data that highlight our strategic approach to drug development in oncology, as well as coming together with the scientific community to exchange information about how the critical work in this field can continue to better the lives of patients.”
Key data highlighting approved or investigational therapies from Bristol Myers Squibb at ESMO 2022 include:
- Exploratory analyses from CheckMate -816 evaluating neoadjuvant Opdivo with platinum-doublet chemotherapy in patients with resectable non-small cell lung cancer, including pathological features analysis and health-related quality of life outcomes.
- Biomarker analyses from CheckMate -274 evaluating adjuvant Opdivo in patients with muscle-invasive urothelial carcinoma, including tumor and immune features associated with disease-free survival.
- Exploratory analyses from CheckMate -915 evaluating adjuvant Opdivo and Opdivo plus Yervoy in patients with stage IIIB-D/IV melanoma, including the association of pre-treatment ctDNA with disease recurrence and clinical and translational factors.
- Four-year update and biomarker analyses from CheckMate -743 evaluating first-line Opdivo plus Yervoy vs. chemotherapy in patients with unresectable malignant pleural mesothelioma.
- Exploratory analysis from CheckMate -9LA evaluating Opdivo plus Yervoy with two cycles of chemotherapy vs. chemotherapy alone in patients with metastatic non-small cell lung cancer and tumor PD-L1 expression <1%.
- Additional response outcomes from RELATIVITY-047 evaluating Opdualag (nivolumab and relatlimab-rmbw), the fixed-dose combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, vs. Opdivo monotherapy in previously untreated metastatic or unresectable melanoma.
- Safety, efficacy, pharmacokinetic and pharmacodynamic data from the Phase 1/2 study of BMS-98629 alone and in combination with nivolumab in patients with advanced cancers.
- In addition, Exelixis announces first presentation of results from the COSMIC-313 study evaluating the combination of cabozantinib, nivolumab and ipilimumab vs. the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma.
Summary of Select Presentations
|
Abstract Title |
Author |
Presentation |
Session Title |
Session/Poster |
|
Adrenocortical Carcinoma/Malignant Pheochromocytoma |
||||
|
EO2401 (EO) therapeutic vaccine for patients (pts) with adrenocortical carcinoma (ACC) and malignant pheochromocytoma/paraganglioma (MPP): phase 1/2 SPENCER study |
Eric Baudin |
Mini Oral |
Mini Oral |
Monday,
09:40-09:45 CEST |
|
Gastrointestinal |
||||
|
PD-L1 Detection Using Combined Positive Score (CPS) and Assay Performance in Gastric, Gastroesophageal Junction (GEJ), and Esophageal Carcinoma Using PD-L1 IHC 28-8 pharmDx |
Tabitha Chan |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
A phase II study of regorafenib in combination with nivolumab in patients with recurrent or metastatic solid tumors: results of the ESCC cohort |
Li-Yuan Bai |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Genitourinary |
||||
|
Adjuvant nivolumab plus ipilimumab versus placebo for localized renal cell carcinoma at high risk of relapse after nephrectomy: results from the randomized, phase 3 CheckMate 914 trial |
Robert J. |
LBA4 |
Presidential |
Sunday,
16:30-16:45 CEST |
|
Tumor and immune features associated with disease-free survival (DFS) with adjuvant nivolumab (NIVO) in the phase III CheckMate 274 trial |
Andrea |
Mini Oral |
Mini Oral |
Monday,
09:05-09:10 CEST |
|
Bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) in previously untreated advanced renal cell carcinoma (RCC): Results from a Phase 3 randomized study (PIVOT-09) |
Nazir Tannir |
LBA68 |
Proffered |
Monday,
14:45-14:55 CEST |
|
Phase 3 study of cabozantinib (C) in combination with nivolumab (N) and ipilimumab (I) in previously untreated advanced RCC (aRCC) of intermediate or poor risk (COSMIC-313) |
Toni K. |
LBA8
|
Presidential |
Monday,
16:30-16:45 CEST |
|
Association between health-related quality of life (HRQoL) and clinical outcomes in patients with first-line (1L) advanced renal cell carcinoma (aRCC): exploratory analysis of CheckMate 9ER (CM 9ER) |
David Cella |
Poster |
Poster
|
Monday,
10:25-10:35 CEST |
|
Analysis of long-term efficacy outcomes from the CheckMate 025 (CM 025) trial comparing nivolumab (NIVO) vs everolimus (EVE) based on ≥ 7 years (yrs) of follow-up in pre-treated patients (pts) with advanced renal cell carcinoma (aRCC) |
Bernard Escudier |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Real-world (RW) outcomes in metastatic renal cell carcinoma (mRCC) patients treated with first-line (1L) nivolumab plus ipilimumab (NIVO+IPI) in the United States |
Daniel M. Geynisman |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Long-term survivorship rates for first-line intermediate or poor (I/P) risk advanced renal cell carcinoma (aRCC) patients achieving objective response (OR) with nivolumab plus ipilimumab (N+I) |
Saby George |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
IO-Synthesise RCC: analysis of real-world (RW) health-related quality of life (HRQoL) outcomes with nivolumab for previously treated metastatic renal cell carcinoma (mRCC) using pooled data from France and Germany |
Guillaume |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
IO-Synthesise RCC: Real-world outcomes of nivolumab in patients (pts) with previously treated advanced non-clear cell renal cell carcinoma (nccRCC): a pooled analysis from France and Germany |
Philippe |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Cost-effectiveness (CE) of nivolumab (NIVO) as adjuvant treatment of muscle invasive urothelial carcinoma at high risk of recurrence (MIUC-HR) in France |
Marie Sylivie |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Characteristics, management and survival of French patients (pts) with Muscle Invasive Bladder Cancer (MIBC) at high risk of recurrence: a study based on the COBLAnCE cohort |
Alderic |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Disease-free survival (DFS) and distant metastasis-free survival (DMFS) as surrogates for overall survival (OS) in adjuvant treatment of muscle invasive bladder cancer (MIBC) |
Cora |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Glioblastoma |
||||
|
EO2401 (EO) therapeutic vaccine for patients (pts) with recurrent glioblastoma (GB): phase 1/2 ROSALIE study |
David A. |
Poster |
Poster |
Saturday,
12:00-13:00 CEST |
|
Gynecological |
||||
|
Safety and efficacy of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic cervical cancer (R/M Cx Ca) in CheckMate 358 |
Ana Oaknin |
Mini Oral |
Mini Oral
|
Saturday,
08:40-08:45 CEST |
|
Head and Neck |
||||
|
Effectiveness and quality-of-life (QoL) data from real-world study (ProNiHN) in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN) treated with nivolumab (nivo) in France |
Christophe |
Poster |
Poster |
Sunday,
12:00-13:00 CEST |
|
HANNA: Real-world data of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), including first-line population, treated with nivolumab in Germany |
Christine |
Poster |
Poster |
Sunday,
12:00-13:00 CEST |
|
Thoracic |
||||
|
First-line nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) in patients with unresectable malignant pleural mesothelioma (MPM): 4-year update from CheckMate 743 |
Gérard |
LBA71 |
Mini Oral |
Monday,
15:15-15:20 CEST |
|
Clinical outcomes in patients (pts) with tumor PD-L1 < 1% with first-line (1L) nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of chemotherapy (chemo) vs chemo alone for metastatic NSCLC (mNSCLC): Results from CheckMate 9LA |
Thomas John |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
|
Analysis of pathological features and efficacy outcomes with neoadjuvant nivolumab (N) plus platinum-doublet chemotherapy (C) for resectable non-small cell lung cancer (NSCLC) in CheckMate 816 |
Janis Taube |
LBA50
|
Mini Oral |
Monday,
15:50-15:55 CEST |
|
Nivolumab (NIVO) plus platinum-doublet chemotherapy (chemo) versus chemo as neoadjuvant treatment for resectable non-small cell lung cancer (NSCLC): health-related quality of life (HRQoL) outcomes from CheckMate 816 |
Enriqueta |
Mini Oral |
Mini Oral |
Monday,
15:45-15:50 CEST |
|
Treatment switching adjustment of overall survival in the CheckMate 227 clinical trial of nivolumab plus ipilimumab versus chemotherapy in first line treatment of patients with advanced non–small-cell lung cancer |
Martin Reck |
Poster |
Poster
|
Monday,
12:00-13:00 CEST |
|
Adverse event (AE) burden of nivolumab-based immuno-oncology (IO) therapy with/without chemotherapy (chemo) for first-line (1L) advanced non-small cell lung cancer (aNSCLC) |
Lee |
Poster |
Poster
|
Monday,
12:00-13:00 CEST |
|
Melanoma |
||||
|
Nivolumab (NIVO) + relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: additional response outcomes from RELATIVITY-047 |
Hussein |
Poster |
Poster
|
Saturday,
12:00-13:00 CEST |
|
Association of Pre-Treatment ctDNA with Disease Recurrence and Clinical and Translational Factors in Patients with Stage IIIB-D/IV Melanoma Treated with Adjuvant Immunotherapy (CheckMate 915) |
Georgina |
Proffered |
Proffered |
Monday,
10:25-10:35 CEST |
|
PIVOT IO 001: first disclosure of efficacy and safety of bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) vs NIVO monotherapy in advanced melanoma (MEL) |
Adi Diab |
Proffered |
Proffered |
Saturday,
15:40-15:50 CEST |
|
Subcutaneous vs intravenous nivolumab in patients with melanoma following complete resection |
Paolo |
Poster |
Poster
|
Saturday,
12:00-13:00 CEST |
|
PRESERV MEL: Real-world outcomes and health-related quality of life (HRQoL) in patients receiving adjuvant nivolumab for melanoma in Belgium and Luxembourg |
Anne Rogiers |
Poster |
Poster |
Saturday,
12:00-13:00 CEST |
|
Investigating surrogate endpoints (SE) for overall survival (OS) in first-line (1L) advanced melanoma: A pooled-analysis of immune checkpoint inhibitor (ICI) trials |
James Larkin |
Poster |
Poster |
Saturday,
12:00-13:00 CEST |
|
Cross-Tumor/Solid Tumor |
||||
|
Patient preference for subcutaneous nivolumab (NIVO) with/without recombinant human hyaluronidase PH20 (RHuPH20) vs intravenous NIVO: an exploratory analysis of a phase 1/2 pharmacokinectic multi-tumor study |
Sara Lonardi |
Poster |
Poster
|
Monday,
12:00-13:00 CEST |
|
Personalized, off-the-shelf KRAS neoantigen-specific immunotherapy for the treatment of advanced solid tumors: clinical benefit associated with decreases in ctDNA (SLATE-KRAS) |
Chrisann Kyi |
Mini Oral |
Mini Oral |
Saturday,
15:50-15:55 CEST |
|
Real-world management of immune-related adverse events in the community setting |
Douglas |
Poster |
Poster
|
Saturday,
12:00-13:00 CEST |
|
Organizational impact of immune-checkpoint inhibitors in advanced cancers based on the French ‘Organizational Impact Map’ published by the Haute Autorité de Santé (HAS): final analysis |
Isabelle Borget |
Poster |
Poster |
Monday,
12:00-13:00 CEST |
| Early Assets | ||||
|
Anti–Cytotoxic T Lymphocyte Antigen-4 (CTLA 4) Probody BMS-986249 ± Nivolumab (NIVO) in Patients (pts) With Advanced Cancers: Updated Phase 1 Results |
Martin Gutierrez |
Poster |
Poster
|
Monday,
12:00-13:00 CEST |
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
OPDIVO U.S. INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
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 adult 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), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
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 adult 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 adult 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.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
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.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older 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.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 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 the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
OPDIVO IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY.
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