Bristol Myers Squibb Data at ASCO and EHA 2022 Highlight Progress in Transforming Treatment for Patients with Cancer and Blood Disorders

Long-term data from Opdivo plus Yervoy-based combinations demonstrate durable survival in metastatic non-small cell lung cancer (NSCLC) and metastatic melanoma, including results from landmark five-year analysis of CheckMate -227 in NSCLC

First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm

New data from pivotal MEDALIST and BELIEVE studies of Reblozyl in myelodysplastic syndromes and beta thalassemia highlight long-term anemia control in serious myeloid diseases

Data from pivotal RELATIVITY -047 trial studying Opdualag reinforce efficacy of LAG-3 mechanism in advanced melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #ASCO22—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of scientific research across cancers and blood disorders at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Congress that underscores the company’s commitment to delivering transformational therapies for patients. Data from more than 140 company-sponsored studies, investigator-sponsored studies and collaborations evaluating compounds across 28 cancer types and blood disorders will be featured at the two meetings.

“We have made significant progress for patients with cancer and blood disorders by delivering clinically meaningful and differentiated treatment choices across modalities such as CAR T, immunotherapy and erythroid maturation,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “Driven by our deep understanding of human biology and leading scientific research, the results being presented at ASCO and EHA will provide greater insight into the potential for improving long-term outcomes, and rationale for moving innovative interventions into earlier lines of treatment. Beyond our data, we are focused on improving care for all patients through our Health Equity Commitments, aimed at increasing diversity in clinical trials, addressing health disparities, and investing in training for racially and ethnically diverse clinical investigators.”

Key data being presented by Bristol Myers Squibb at ASCO and EHA 2022 include:

Solid Tumor

• Landmark five-year analysis of CheckMate -227, the longest reported follow-up of a Phase 3 immunotherapy combination study in first-line metastatic non-small cell lung cancer (NSCLC), demonstrate long-term, durable survival outcomes with Opdivo (nivolumab) plus Yervoy (ipilimumab).
• Three-year follow-up data from CheckMate -9LA reinforce the long-term, durable survival outcomes of Opdivo plus Yervoy with two cycles of chemotherapy, in the first-line treatment of patients with metastatic NSCLC, including those with PD-L1 expression <1%.
• Analyses from the CheckMate -816 trial highlight the association between pathological response and improved event-free survival in patients with resectable NSCLC treated with Opdivo plus chemotherapy in the neoadjuvant setting.
• Overall survival and overall response rate data from the RELATIVITY-047 trial evaluating Opdualag (nivolumab and relatlimab-rmbw), the combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, demonstrate the clinical benefit of the company’s third distinct checkpoint inhibitor in patients with advanced melanoma. These data were first disclosed at the March ASCO Plenary Series.
• With the longest reported follow-up of median overall survival from a Phase 3 advanced melanoma trial, seven and a half-year survival results will be presented on the combination of Opdivo plus Yervoy from CheckMate -067 in patients with advanced melanoma.

Cell Therapy

• First disclosure of data from the PILOT study of Breyanzi (liso-cel), in patients with relapsed or refractory large B-cell lymphoma after one line of therapy who were not intended for transplant, show substantial durable responses. A patient-reported outcomes analysis from PILOT also showed treatment with Breyanzi improved health-related quality of life measures for patients.
• Correlative analysis of characteristics of patients treated with Abecma (ide-cel) in the KarMMa and KarMMa-2 clinical trials, with CAR T product quality attributes, informs further insights into potentially optimizing patient selection for CAR T manufacturing and improving clinical outcomes.

Hematology

• Long-term data from pivotal MEDALIST and BELIEVE studies highlight continued benefit of Reblozyl (luspatercept-aamt) for patients with lower-risk myelodysplastic syndromes and transfusion-dependent beta thalassemia (ASCO/EHA).
• Long-term survival results from the pivotal Phase 3 QUAZAR^® AML-001 study, highlight the survival benefit of Onureg (azacitidine tablets) following intensive chemotherapy (EHA).

Early Assets

• First dose expansion data for Eisai and Bristol Myers Squibb’s co-developed antibody-drug conjugate MORAb-202, demonstrate anti-tumor activity in platinum-resistant ovarian cancer patients at two dose levels as well as benefits of exploration of body surface area dosing to optimize safety.
• Data from Phase 1 studies of CC-99282, a cereblon E3 ligase modulator (CELMoD^®) agent, and CC-95251, an anti-signal regulatory protein-alpha (SIRPα) antibody combined with rituximab, show promising activity in patients with relapsed or refractory non-Hodgkin lymphoma (EHA).
• Health-related quality of life data from the Phase 1/2 MM-001 study of iberdomide plus dexamethasone, underscore the potential of CELMoD^® compounds in patients with relapsed or refractory multiple myeloma (EHA).

Summary of Presentations

Select Bristol Myers Squibb studies at the 2022 ASCO Annual Meeting include:

Abstract Title	Author	Presentation Type/#	Session Title	Session Date/ Time
Acute Myeloid Leukemia
Health-related quality of life (HRQoL) with enasidenib versus conventional care regimens in older patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML).	Courtney DiNardo	Poster Abstract #7032	Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Assessing eligibility for non-intensive chemotherapy (IC) randomized clinical trials (RCT) in patients (pts) with newly diagnosed (ND) AML from the Connect Myeloid Disease Registry.	Harry Erba	Poster Abstract #7029	Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Overall survival by IDH2 mutant allele (R140 or R172) in patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib or conventional care regimens in the phase 3 IDHENTIFY trial.	Stephane De Botton	Oral Abstract #7005	Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant	Tuesday, June 7, 2022: 10:45 AM – 1:45 PM EDT
Gastrointestinal
Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) versus chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): Expanded efficacy and safety analyses from CheckMate 648.	Ian Chau	Poster Abstract #4035	Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Five-year follow-up from CheckMate 142.	Michael Overman	Poster Abstract #3510	Gastrointestinal Cancer—Colorectal and Anal	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Genitourinary
Association between depth of response (DepOR) and clinical outcomes: Exploratory analysis in patients with previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 9ER.	Cristina Suarez	Oral Abstract #4501	Genitourinary Cancer—Kidney and Bladder	Friday, June 3, 2022: 3:45 PM – 6:45 PM EDT
The relationship between health-related quality of life (HRQoL) and clinical outcomes in patients with advanced renal cell carcinoma (aRCC) in CheckMate (CM) 214.	David Cella	Oral Abstract #4502	Genitourinary Cancer—Kidney and Bladder	Friday, June 3, 2022: 3:45 PM – 6:45 PM EDT
Racial differences in treatment patterns and outcomes of first-line (1L) therapies for advanced renal cell carcinoma (aRCC) in the real-world (RW) setting.	Daniel Geynisman	Poster Abstract #4548	Genitourinary Cancer—Kidney and Bladder	Saturday, June 4, 2022: 2:15 PM – 5:15 PM EDT
Prognostic value of the lung immune prognostic index in patients with untreated advanced renal cell carcinoma (aRCC) receiving nivolumab plus ipilimumab (N+I) or sunitinib (SUN) in the CheckMate 214 trial.	Lucia Carril-Ajuria	Poster Abstract #4538	Genitourinary Cancer—Kidney and Bladder	Saturday, June 4, 2022: 2:15 PM – 5:15 PM EDT
Results for patients with muscle-invasive bladder cancer (MIBC) in the CheckMate 274 trial.	Alfred Witjes	Poster Abstract #4585	Genitourinary Cancer—Kidney and Bladder	Saturday, June 4, 2022: 2:15 PM – 5:15 PM EDT
Melanoma
Nivolumab (NIVO) + relatlimab (RELA) versus NIVO in previously untreated metastatic or unresectable melanoma: OS and ORR by key subgroups from RELATIVITY-047.	Hussein A. Tawbi	Oral Abstract #9505	Melanoma/Skin Cancers	Sunday, June 5, 2022: 10:45 AM – 1:45 PM EDT
Relatlimab and nivolumab versus nivolumab in previously untreated metastatic or unresectable melanoma: Overall survival and response rates from RELATIVITY-047 (CA224-047).	Georgina V. Long	Oral Abstract #360385	ASCO Plenary Series: Rapid Abstract Updates	Sunday, June 5, 2022: 5:30 PM – 7:00 PM EDT
Long-term survival in advanced melanoma for patients treated with nivolumab plus ipilimumab in CheckMate 067.	F. Stephen Hodi	Poster Abstract #9522	Melanoma/Skin Cancers	Monday, June 6, 2022: 2:15 PM – 5:15 PM EDT
Outcomes in patients with resected stage IIIA melanoma treated with adjuvant nivolumab or monitored with observation: A real-world study.	Anna C. Pavlick	Online only	Online only	Online only
Multiple Myeloma
Pomalidomide, bortezomib, and dexamethasone in lenalidomide-pretreated multiple myeloma: A subanalysis of OPTIMISMM by frailty.	Albert Oriol Rocafiguera	Poster Abstract #8024	Hematologic Malignancies—Plasma Cell Dyscrasia	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Characteristics of long-surviving patients with multiple myeloma: Over 12 years of follow-up in the Connect MM Registry.	Howard R. Terebelo	Poster Abstract #8027	Hematologic Malignancies—Plasma Cell Dyscrasia	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Correlative analysis to define patient profiles associated with manufacturing and clinical endpoints in relapsed/refractory multiple myeloma (RRMM) patients treated with idecabtagene vicleucel (ide-cel; bb2121), an anti-BCMA CAR T cell therapy.	Julie Rytlewski	Poster Abstract #8021	Hematologic Malignancies—Plasma Cell Dyscrasia	Saturday, June 4, 2022: 5:30 PM – 7:00 PM EDT
Myelodysplastic Syndromes
Long-term utilization and benefit of luspatercept in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) from the MEDALIST trial.	Pierre Fenaux	Poster Abstract #7056	Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Real-world erythropoiesis-stimulating agent (ESA) treatment patterns and outcomes among U.S. patients with lower-risk myelodysplastic syndromes (LR-MDS).	Sudipto Mukherjee	Online only	N/A	Online only
Clinical outcomes and healthcare resource utilization (HCRU) in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) reinitiating erythropoiesis-stimulating agents (ESAs) following previous ESA treatment.	Guillermo Garcia-Manero	Online only	N/A	Online only
Lymphoma
Lisocabtagene maraleucel (liso-cel) as second-line (2L) therapy for R/R large B-cell lymphoma (LBCL) in patients (pt) not intended for hematopoietic stem cell transplantation (HSCT): Primary analysis from the phase 2 PILOT study.	Alison Sehgal	Poster Abstract #7062	Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant	Saturday, June 4, 2022: 9:00 AM – 12:00 PM EDT
Lisocabtagene maraleucel (liso-cel) as second-line (2L) treatment (tx) for R/R large B-cell lymphoma (LBCL) in patients (pt) not intended for hematopoietic stem cell transplantation (HSCT): Patient-reported outcomes (PRO) from the phase 2 PILOT study.	Leo I. Gordon	Poster Abstract #6567	Health Services Research and Quality Improvement	Monday, June 6, 2022: 2:15 PM – 5:15 PM EDT
Ovarian
Safety and efficacy of MORAb-202 in patients (pts) with platinum-resistant ovarian cancer (PROC): Results from the expansion part of a phase 1 trial.	Shin Nishio	Poster Abstract #5513	Gynecologic Cancer	Saturday, June 4, 2022: 5:30 PM – 7:00 PM EDT
Dose optimization for MORAb-202, an antibody-drug conjugate (ADC) highly selective for folate receptor-alpha (FRα), using population pharmacokinetic (PPK) and exposure-response (E-R) efficacy and safety analyses.	Seiichi Hayato	Poster Abstract #3090	Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology	Sunday, June 5, 2022; 9:00 AM – 12:00 PM EDT
Thoracic
Five-year survival outcomes with nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) as first-line (1L) treatment for metastatic non–small cell lung cancer (NSCLC): Results from CheckMate 227.	Julie R. Brahmer	Poster Abstract #LBA9025	Lung Cancer—Non-Small Cell Metastatic	Monday, June 6, 2022: 9:00 AM – 12:00 PM EDT
First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients (pts) with metastatic non–small cell lung cancer (NSCLC): 3-year update from CheckMate 9LA.	Luis G. Paz-Ares	Poster Abstract #LBA9026	Lung Cancer—Non-Small Cell Metastatic	Monday, June 6, 2022: 9:00 AM – 12:00 PM EDT
Association of early tumor growth rate and survival outcomes in first-line metastatic non–small cell lung cancer (mNSCLC).	Antonio Tito Fojo	Poster Abstract #9063	Lung Cancer—Non-Small Cell Metastatic	Monday, June 6, 2022: 9:00 AM – 12:00 PM EDT
Neoadjuvant nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) versus chemo for resectable (IB–IIIA) non-small cell lung cancer (NSCLC): Association of pathological regression with event-free survival (EFS) in CheckMate 816.	Mariano Provencio-Pulla	Poster Abstract #LBA8511	Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers	Monday, June 6, 2022: 12:30 PM – 2:00 PM EDT

All abstracts except late-breaking abstracts will be available on the ASCO website at 5:00 PM EDT on Thursday, May 26. All late-breaking abstracts will be available on the ASCO website at 8:00 AM EDT on the day of the scientific session for the abstract presentation.

Select Bristol Myers Squibb studies at the 2022 EHA Congress include:

Abstract Title	Author	Presentation Type/#	Session Date/Time
Acute Myeloid Leukemia
Clinical and Biological Markers Associated With Long-term Survival for Patients With Acute Myeloid Leukemia (AML) in Remission After Chemotherapy in the QUAZAR AML-001 Trial of Oral Azacitidine	Andrew Wei	Poster Abstract #P498	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Real-World Efficacy Outcomes of Venetoclax Plus Azacitidine vs. Intensive Chemotherapy for Induction Therapy in Adult Patients with Acute Myeloid Leukemia	Amer Zeidan	Poster Abstract #P570	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Oral Azacitidine vs. Midostaurin as Maintenance Treatment for FLT3 Mutant Acute Myeloid Leukemia in Complete Remission: An Indirect Treatment Comparison	Esther Natalie Olivia	Poster Abstract #P571	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Beta thalassemia
Long-term Safety Results of the BELIEVE Study of Luspatercept in Adults with Beta-thalassemia	Vip Viprakasit	Poster Abstract #P1518	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Examining the Burden of Illness Associated With Transfusion-Dependent Βeta-Thalassemia From the Patient’s Perspective	Russell L. Knoth	Poster Abstract #P1741	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Systematic Literature Review of the Burden of Illness and Outcome Analyses of Patients with Non-transfusion Dependent Beta Thalassemia	Yesim Aydinok	Poster Abstract #P1742	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Longer-term Analysis of Efficacy of Luspatercept vs. Placebo in Patients with Transfusion-Dependent Beta-thalassemia Enrolled in the BELIEVE Study	Maria Domenica Cappellini	Oral Abstract #S270	Saturday, June 11, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Lymphoma
Accuracy of Predicting Long-Term Survival of Chimeric Antigen Receptor (CAR) T Cell Therapies in Large B-Cell Lymphoma (LBCL)	Elisabeth J.M Verburg-Baltussen	Poster Abstract #P1744	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Treatment Patterns and Real-World Outcomes in Patients (PT) with Large B-Cell Lymphoma (LBCL) who received Second-Line (2L) Therapy	Matthew A. Lunning	Poster Abstract #P1204	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Lisocabtagene Maraleucel (liso-cel) as Second-Line Therapy for R/R Large B-Cell Lymphoma (LBCL) in Patients not Intended for HSCT: Primary Analysis from the Phase 2 PILOT Study	Alison Sehgal	Oral   Abstract #S258	Saturday, June 11, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Clinical Activity of CC-99282, a Cereblon E3 Ligase Modulator (CELMoD) Agent, in Patients (PTS) With Relapsed/Refractory Non-Hodgkin Lymphoma (R/R NHL) – Results From a Phase 1, Open-Label Study	Jean-Marie Michot	Oral Abstract #S216	Sunday, June 12, 2022: 12:30 PM – 1:45 PM EDT (6:30 – 7:45 PM CEST)
First Clinical Study of the Anti-Signal Regulatory Protein-alpha (SIRPα) Antibody CC-95251 Combined With Rituximab in Patients With Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL)	Paolo Strati	Oral Abstract #S219	Sunday, June 12, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Multiple Myeloma
Tumor Profiling of Idecabtagene Vicleucel (Ide-cel; bb2121) Patients in KarMMa Showed Comparable Responses in Existing Molecular High-risk Subsets and Preliminary Gene Signature of Durable Response	Nathan Martin	Poster Abstract #P867	Friday, June 10,2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Idecabtagene Vicleucel vs. Belantamab Mafodotin: a Matching-Adjusted Indirect Comparison Study	Nina Shah	Poster Abstract #P1740	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)
Biomarker Analysis to Support Dose Optimization of Iberdomide as Monotherapy and in Combination with Standard of Care Treatments for Multiple Myeloma From a Phase 1/2 Trial	Michael Amatangelo	Poster Abstract #P865	Friday, June 10, 2022: 12:30 – 1:45 PM EDT (6:30 – 7:45 PM CEST)

The EHA presentations will be available on demand on Monday, June 20.

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 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.

Contacts

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