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Bristol-Myers Squibb to Present New Data on 20 Types of Cancer from Across its Oncology Portfolio at ASCO and EHA 2019

by:Earlston     2020-01-26
Bristol-
Myers Squibb will present new data on 20 cancers on ASCO and EHA 2019nivolumab)plus Yervoy (ipilimumab)
Patients with advanced liver cancer and patients with melanoma with symptomatic brain metastasis
Long-term survival data and health outcomes of Opdivo combined with Yervoy for advanced melanoma
Results of monthly efficacy of Empliciti (elotuzumab)
Plus, uh, nadiamine and low-
Dose dex for the multi-grain spinal cord tumor national study for recurrence/recurrence explore the use of new technologies and artificial intelligence to understand the association of inflammatory gene features with tumor immune cellsJ. --
Bristol, May 16, 2019-
Shiguibao company (NYSE:BMY)
Announced today that data from the company\'s tumor product portfolio will be displayed at the American Society of Clinical Oncology (ASCO)
2019 Annual Meeting held in Chicago in May 31
June 4, 24 annual meeting of the European Society of Blood (EHA)
June 13-Amsterdam16.
Data from more than 90 companies
Research sponsored by researchers
The two sessions will present sponsored research and collaboration to evaluate tumor compounds and early translational medicine for 20 cancers.
The speech will emphasize the role of immunityOncology (I-O)
Single therapies and combined methods for improving outcomes for survival and quality of life, as well as translation studies to investigate new biomarkers and diagnostic methods to help select customized treatments based on the unique disease biology of each patient.
2019 Annual ASCO-
Highlights of Bristol
Miles shiguibao\'s data include: * all recorded times are the main efficacy and safety results of liver cancer * Phase 1/2 examination at Central Daylight
Research on the combination of 040 evaluation Opdivo (nivolumab)plus Yervoy(ipilimumab)
In patients with advanced liver cancer, the most common type of liver cancer will occur. These data (Abstract#4012)
Including objective response rate and overall survival rate, to be presented on the poster on Monday, June 3
CDT at eleven o\'clock A. M. and at 3-4:30 PM CDT.
Safety and efficacy of melanoma * Opdivo combined with Yervoy in the treatment of patients with symptomatic melanoma brain metastasis (Abstract #9501)
Oral meeting will be held on Tuesday, June 4 at 9: 45 A. M. 12:45 PM CDT. *New long-
Long-term survival data and health outcomes study to evaluate the combined application of Opdivoin and Yervoy in advanced melanoma
In terms of survival outcomes (CA209-
004, summary #9533)
Quality of life after four years and during treatment
Free interval after stopping treatment (CheckMate -
067, summary #9551, #9568)And treatmentfree survival(
Summary data from check mate067 and -
069, abstract #9550)
-Will be shown on the poster display on Monday, June 3 at 1: 15-4:15 PM CDT.
Safety and efficacy of renal tumor * Opdivo combined with Yervoy in the treatment of patients with asymptomatic advanced renal tumor brain metastasis (Abstract#4517)
Will be shown in the poster display on Monday, June 3
CDT at 4: 15 p. m. in the poster discussion at 4: 30 --6 PM CDT.
Translation medical and Oncology Biology * translation data will be presented to identify potential predictive biomarkers and translation research capabilities.
By using gene expression profiles (GEP)and machine-
Learning modeling, research, cancer
The relevant inflammatory gene features were identified by the associated immune tissue chemistry evaluation of CD8 expression on T cells. This CD8-
Derivative signatures are then used to evaluate the inflammation of the tumor micro-environment of 12 tumor types (Abstract #2593).
In addition, the use of innovative artificial intelligence
T-based approach
Through the cellular localization gene features of GEP, the researchers quantified the abundance of immune cells and their spatial location in the tumor micro-environment (Abstract #2594).
The two summaries will be published at the poster meeting on Saturday, June 1. 11 AM CDT.
EHA 24 annual meeting-
Highlights of Bristol
Shi Guibao datainclude: * always pointed out that the TimeMultiple multiple tumor * Extension Act of the Central European standard-month follow-
Data from Phase 23 trial(
Summary # PS1370
Evaluation except Empliciti (elotuzumab)
Come to nadiamine and low-
Dose of patients with recurrence/recurrenceR/R)
Mm, including a descriptive overall survival analysis of the combination, will be presented on the poster at 5: 30 on Saturday, June 157 PM CEST.
Classic he Jiejin and Fei
Nhl lymphoma * updates the safety and efficacy results of two patient groups examined in phase 2
744 study, first risk
Layered response
Adaptive Research of Opdivo and ADCETRIS (
Blentuci (vedotin)
Subsequently, in children, adolescents and young people with R/R classic hochkin\'s lymphoma, ADCETRISand bendstine stine had a sub-optimal response (cHL)
Before the transplant of autologous stem cells (Abstract #S822)
Will be presented at 12: 30 on Saturday, June 15 in the oral report-12:45 PM CEST. *Two-
Annual results of Phase 2 death cohort D
205 studies to evaluate Opdivo polybeniclazide, Changchun alkali, and dakabasine in newly diagnosed advanced patientsstage cHL (Abstract #S821)
Will be presented at 12: 15 on Saturday, June 15 in the oral report-12:30 PMCEST.
* Comprehensive analysis of Phase 1/2-
436 study, evaluation of Opdivoand ADCETRIS in patients with R/R primary longitudinal Greater B-celllymphoma (Summary # S1601)
Will be presented in the oral report on Sunday, June 169:15 AM CEST.
2019 Annual ASCO-Company-
Data for sponsorship and collaboration include: * all recorded times are intestinal and gastric cancer when central Daylight * Nivolumab (NIVO)+ ipilimumab (IPI)
Comprehensive treatment of patients (pts)
Advanced liver cancer (aHCC)
Author: YauAbstract: #4012 poster discussion session: intestines and stomach (Noncolorectal)
Poster display on Monday, June 3: 8-
ADiscussion Hall, eleven o\'clock A. M. : 3-
At 4: 30 p. m. , the Arui theater staged * Nivolumab (NIVO)+ low-
Dose of ipilimumab (IPI)as first-line (1L)
Treatment of micro-satellite instability
High/DNA mismatch repair defects (MSI-H/dMMR)
Metastasis of colorectal cancer (mCRC)
Author: LenzAbstract: #3521 poster theme: intestines and stomach (Colorectal)
Poster display on Monday, June 3: 8-
Eleven o\'clock A. M. AMelanoma Hall * Long-term follow-up of CA209-
004: Late dose-
Study on the upgrade of nivolumab (NIVO)
And ipilimumab (IPI)
Author: AtkinsAbstract: #9533 poster Conference: Melanoma/skin cancer on Monday, June 3, Poster Display: 1:15-
4: 15 p. m. , sensitivity of treatment in Hall-free survival (TFS)
, A new result, grouping analysis of patients (pts)
Advanced melanoma (MEL)
With an immune checkpoint inhibitor (ICI)
Author: mantia Digest: #9550 Poster Session: Melanoma/skin cancer Monday, June 3 Poster Display: 1:15-
4: 15 p. m. , Hall *
Quality of Life (QoL)
Late study of Nivolumab in patients with advanced melanoma (NIVO)
With or without ipilimumab (IPI)
VersusIPI: check mate 067 4-
Years dataauthor: schadendorfabstract: #9551 poster meeting: Melanin/skin cancersmonday June 3 poster show: 1:15-
4: 15 p. m. , Hall A * of quality of life (QoL)
Burden of symptoms in patients (pts)
Advanced melanoma during treatmentfree interval (TFI)
Ofnivolumab after withdrawal (NIVO)
Or NIVO plus ipilimumab (IPI)
Author: halllorabstract: #9568 Poster Session: Melanoma/skin cancer, Monday, June 3, Poster Display: 1: 15-
Analysis of nivolumab in Hall A at 4: 15 p. m.
Stage III or IV melanoma-mediated adverse events of resection and association with clinical efficacy (CheckMate 238)
Author: MandalaAbstract: #9584 Poster Session: Monday, June 3, melanoma/skin cancer, Poster Display: 1: 15-
Efficacy and safety of Hall A * nivolumab combination at 4: 15 p. m (NIVO)
With ipilimumab (IPI)
Patients with symptomatic melanoma brain metastasis (CheckMate204)
Author: TawbiAbstract: #9501 oral Conference: Melanoma/skin cancer, June 4, 9: 45 A. M-
12: 45 pm, s406 demo: 9: 57-
S406 malignant tumor of urinary and reproductive system * check mate 214 at 10: 09 A. M.
Special Analysis of Nivolumab plus ipilimumab or sunitinibin IMDC Intermediate/poor
Risk patients with previously untreated progressive renal cell carcinoma with muscle-like features author: McDermottAbstract: #4513 poster discussion meeting: urinary and reproductive system (Nonprostate)
Poster display on Monday, June 3: 1:15-
4: 15 p. m. , ADiscussion Hall: 4: 30-
Safety and efficacy of Hall D2 * nivolumab plus ipilimumab at six o\'clock P. M (NIVO+IPI)
In patients with advanced renal cell carcinoma (aRCC)
920 author: EmamekhooAbstract: #4517 poster discussion meeting: urinary and reproductive system (Nonprostate)
Poster display on Monday, June 3: 1:15-
4: 15 p. m. , ADiscussion Hall: 4: 30-
At six o\'clock P. M. , Hall D2 * nivolumab plus ipilimumab is in the International Union of transfer databases (IMDC)
214 author: EscudierAbstract: #4575 poster theme: urinary and reproductive system (Nonprostate)
Poster display on Monday, June 3: 1:15-
4: 15 pm, Hall A * clinical and economic results related to sequential treatment in hospitalized patients with advanced renal cell carcinoma (aRCC)
Author: ReganAbstract: #4566 Poster Session: urinary and reproductive system (Nonprostate)
Poster display on Monday, June 3: 1:15-
4: 15 p. m. single drug treatment of A * Nivolumab Hall in patients with advanced Platinum
Drug-Resistant Epithelial Cancer: efficacy and safety update of Checkmate 275 author: Siefker-
#4524 Poster Session: urinary and reproductive system (Nonprostate)
Poster display on Monday, June 3: 1:15-
4: 15 p. m. Hall
World results of IO treatment: Prospective Observational cohortresearch for patients (pts)
Advanced melanoma (OPTIMIzE)
Author: KirkwoodAbstract: # e14144Online only medical and biomarkers * serum IL-
6 and CRP as prognostic factors in patients with melanoma receiving single drug and combined checkpoint inhibition author: WeberAbstract: #100 clinical science workshop: Fine-
Regulatory checkpoint inhibition: Biomarkers of response and resistance, June 1, clinical science workshop: 8-
At 9: 30 a. m. , d1 Hall: 8-
At 8: 12 a. m. , Hall D1 * developed baseline prognostic cytokines features associated with nivolumab (NIVO)clearance (CL)
Translation of Pharmacology/Pharmacology (PK/PD)
Analysis of patients with Renalcell cancer (RCC)
Author: WangAbstract: #2544 Poster Session: developmental immunotherapy and tumor immunotherapy June 1, Poster Display: 8-
At eleven o\'clock A. M. , the Association of inflammatory gene features with CD8 expression through immune tissue chemistry (IHC)
Poster display on Saturday, June 1: 8-author in multiple tumor types: SzaboAbstract: #2593 poster display: developmental immunotherapy and tumor immunotherapy
At eleven o\'clock A. M. , through image analysis, Hall A * CD8 T cells in tumor essence and matrix (IA)
Gene expression profile (GEP)
: Potential biomarkers of immunityoncology(I-O)
Poster Display: 8-2594 poster display on Saturday, June 1: developing immunotherapy and tumor immunotherapy
At eleven o\'clock A. M. , the Association of Human endogenous reverse transcription virus A * Hall (hERV)
Expression of clinical efficacy of Parkinson\'s disease
1 blocked metastasis of renal clear cell carcinoma (mccRCC)
Author: PignonAbstract: #4568 Poster Session: Urology (Nonprostate)
Poster display on Monday, June 3: 1:15-
4: 15 p. m. , New and early Asset * baseline tumor-
Immune features associated with immune responseNKTR-214)
And nivolumabAuthor author: HurwitzAbstract: #2623 poster Conference: development of immunotherapy and tumor immunotherapy Saturday, June 1 Poster Presentation: 8-
Eleven o\'clock A. M. , A * Cajun-Hall
060: randomized open-label phaseII trial of relatlimab (anti-LAG-3)
And nivolumab chemotherapy with nivolumab withchemotherapy first
First-line treatment of patients with gastric and esophageal junction adenocarcinoma author: FeeneyAbstract: # tp4143 poster meeting: intestines and stomach (Noncolorectal)
Poster display on Monday, June 3: 8-
Eleven o\'clock A. M. , A * CA045-Hall
001: Phase III random open label study of bergamattin (NKTR-214)
Plus nivolumab (NIVO)
Compared with patients treated with NIVO single drug (pts)
Melanoma that has not been treated, is not removed, or is not transferred before (MEL)
Author: KhushalaniAbstract: # tp9601 Poster Session: Melanoma/skin cancer Monday, June 3, Poster Display: 1:15-
4: 15 p. m. , A * A hall Phase II random open label ResearchNKTR-214)
Add in Nitura or sunitini (
Investigator school)
Author: TannirAbstract: # tp4595 poster Conference: urinary and reproductive system (Nonprostate)
Poster display on Monday, June 3: 1:15-
4: 15 p. m. , A randomized study of phase A new auxiliary chemotherapy in Hall (NAC)
Alone or in combination with nivolumab (NIVO)± BMS-
986205 of DDP
Invasive Bladder Cancer (MIBC)
Author: SonpavdeAbstract: # tp4587 Poster Session: urinary and reproductive system (Nonprostate)
Poster display on Monday, June 3: 1:15-
Preliminary immunization, safety and efficacy of Hall AClinical Laboratories * JNJ-at 4: 15 p. m. 64041757 (JNJ-757)in non-
Small cell lung cancer (NSCLC)
Author: BrahmerAbstract: #9093 poster Conference: lung cancer-Non-
Poster display on Sunday, June 2: 8-
Eleven o\'clock A. M. , Hall A *, RP1 as A single drug and combined with PD1 blocking open label, multi-center, I/II study in patients with solid tumors, Saturday, June 1, Poster Display: 8-
At eleven o\'clock A. M. in the afternoon, room A * Ph1/2 of ofRova Research-
Combination of Tin with nivolumab (Nivo)± ipilimumab(Ipi)for patients (pts)
Extensive with 2L --stage (ED)
Abstr: #8516 Poster Session: lung cancer-Non-
Local community-
Poster display on Sunday, June 2: 8-11 AM;
Discussion in the Hall: 12: 45 a. m. to 12: 45 p. m. , EHA-S40624 sessionCompany-
The data for sponsorship and collaboration included: * All time notice of the Central European Summer timelympoma * Nivolumab polybenide, Changchun alkali and daccabassin
Stage of classic hochkin lymphoma: 2-
Extended year-
Author of the 205 study: dominguo-
Domenesh Digest: # s8 21 oral Conference: hochkin\'s lymphoma-Saturday, June 15, at 11: 30 a. m-
Lecture in Hall 5 at 12: 45 p. m-
12: 30 p. m. , Hall 5 Nivolumab and Brentuximab Vedotin-Response based
744 author: LeBlancAbstract: # s8 22 oral Conference: hochkin\'s lymphoma-clinical Saturday, June 15, 11: 30 A. M-
Speech in Hall 5 at 12: 45 p. m-
At 12: 45 pm in the afternoon, Hall 5 * Nivolumab combined with Brentuximab Vedotin in the treatment of recurrent/recurrent large B-
Cell Lymphoma: effectiveness and safety of Phase 2 checkmate 436 study results author: zinzani Digest: # s1601 oral Conference: aggressive lymphoma-first-line, combined therapy, and real-
Life Data Day, June 16
9-15 a. m. , Hall 5 speech: 9-
Hall 5mm * ilotuumab, pomalidamine and dex for recurrence/recurrence mm at 9: 15 pm in the morning: Results of efficacy after additional follow-up
The second stage, random eloquent-
3 Study author: dimopolos abstract: # ps1370 poster Conference: mm and other monoclonal gamm diseases-Saturday, June 15 5: 30-
Seven o\'clock P. M. poster area * multiplemyeloauthor Elotuzumab and the investigation mechanism of lenalamin: Richard dsonabstract: # PF568Poster Conference: single ResearchFriday gammopathies biology and transformation, 5: 30-June 14-
Seven o\'clock P. M. , poster area * use pomalidomede-
Recurrence/refractory multiple PREAMBLEAuthor Myelomain European four countries by course of treatment-results: MoreauAbstract: # ps145poster Conference: single gammopathies-ClinicalSaturday such as multiple mm, 5: 30-June 15-
Seven o\'clock P. M. poster area
One year extension
Efficacy and safety of dashatinib in hospitalized patients (Pts)
Chronic phase of chronic leukemia (CML-CP)
Poster meeting for 3 months of ImatinibAuthor author: SaglioAbstract: # pf405: chronic leukemia-Friday, June 14 5: 30-
Seven o\'clock P. M. , poster area * DASFREE: Month-
Annual Update: the patient stopped using dashatinib (pts)
Chronic leukemia (CML-CP)
Deep Molecular Reaction (DMR)
Author: ShahAbstract: # pf408 Poster Session: chronic leukemia-Friday, June 14-
At seven o\'clock P. M. in the afternoon, the poster area * growth rate and endocrine effects of dasationi treatment were observed in a retrospective analysis of chronic phase II clinical trials in children with chronic leukemia (CML-CP)
Author: PattersonAbstract: # pf46 Poster Session: chronic leukemia-Friday, June 14, 5: 30-
At seven o\'clock P. M. in the afternoon, the poster area * the simple administration mode of dashatini and nilotini, chronic-
Chronic leukemia (CP-CML)Patients (pts)
In routine clinical practice, author: CortesAbstract: # ps1181 poster Conference: chronic leukemia of the marrow cells-Saturday, June 15 5: 30-
Seven o\'clock P. M. poster
Miles shiguibao: research progress of Oncology in Bristol
Miles shiguibao, the patient is the center of everything we do.
The focus of our research is to improve quality.
The long-term survival of patients makes healing possible.
Through the unique, multi-disciplinary approach provided by translation science, we leverage our deep scientific experience in oncology and immunizationOncology (I-O)
The study identifies new treatments that suit the individual needs of patients.
Our researchers are developing a diverse, purposefully constructed pipeline designed to target different immune system pathways and address the complex and specific between tumors, tumor microenvironments, and immune systems
We work internally and with academia, government, advocacy groups, and biotechnology companies to seek innovation to help deliver the promise of transforming drugs, such as I-
O, the reality of the patient.
About the death of the opdivois Program-1 (PD-1)
An immune checkpoint inhibitor designed to uniquely use the body\'s own immune system to help restore resistance
Immune Response to tumor
By using the human body\'s own immune system to fight cancer, opdivoe has become an important treatment option for patients with multiple cancers.
Opdivo\'s leading global development program is based on Bristol-
Miles shiguibao\'s scientific expertise in the field of immunity
Tumors, including extensive clinical trials at all stages of various tumor types, include stage 3.
So far, the theOpdivoclinical development program has treated more than 35,000 patients.
Opdivotrials help to gain insight into the potential role of biomarkers in patient care, especially how patients can benefit from PD\'s ongoing opdivotrialsL1 expression.
In July 2014, opdiv became the first PD-
1 immune checkpoint inhibitor, subject to regulatory approval anywhere in the world.
At present, Opdivois is approved in more than 65 countries such as the United States, the European Union, Japan and China.
In October 2015, the company\'s Opdivo and yercombin combination program was the first immunization
The regulatory approved oncology portfolio that receives treatment for metastatic melanoma is currently approved in more than 50 countries, including the United States and the European Union. U. S. FDA-
Approved indications for OPDIVO ^®OPDIVO ^®(nivolumab)
As a single drug, it is used to treat patients with unremovable or metastatic melanoma. OPDIVO^® (nivolumab)
Combine YERVOY ^®(ipilimumab)
, For the treatment of patients with unremovable or metastatic melanoma. OPDIVO^® (nivolumab)
Treatment for non-transfer patients
Small cell lung cancer (NSCLC)
Progress on or after platinum-
Basic chemotherapy.
Patients with abnormal tumor of the receptor or ALK genome should have disease progression on the FDA
Prior to receiving OPDIVO, treatment for these abnormalities was approved. OPDIVO^® (nivolumab)
Patients with small cell lung cancer for treatment of metastasis (SCLC)
Progress after Platinum
Basic chemotherapy and at least one other therapy.
According to the overall response rate and response duration, the instruction is approved with accelerated approval.
Continuing to approve this indication may be an accidental result of verifying and describing clinical benefits in the validation trial. OPDIVO^® (nivolumab)
Treatment for patients with progressive renal cell carcinoma (RCC)
Who received it before?
Vascular TherapyOPDIVO^® (nivolumab)
Combine YERVOY ^®(ipilimumab)
For patients with advanced renal cell carcinoma at moderate or poor risk of treatment without treatment (RCC). OPDIVO^® (nivolumab)
Suitable for the treatment of adult patients with typical hochkin lymphoma (cHL)
Recurrence or progression after autologous hematopoietic stem cell transplant (HSCT)
Brentuximabvedotin or after 3 or more lines of systematic treatment including autologous transplant.
According to the overall response rate, the instruction was approved with accelerated approval.
The continued approval of this indication may depend on the validation and description of the clinical benefits in the validation trial. OPDIVO^® (nivolumab)
Applicable to the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)
Disease progression after platinum or platinum-based therapy. OPDIVO^® (nivolumab)
Used to treat patients with locally advanced or metastatic urinary tract urinary cancer with disease progression during or after platinum
With chemotherapy or disease progression within 12 months of platinum-assisted or adjuvant therapy
Including chemotherapy.
According to the tumor response rate and response duration, the indication was approved as under accelerated approval.
The continued approval of this indication may depend on the validation and description of the clinical benefits in the validation trial. OPDIVO^® (nivolumab)
As a single drug for the treatment of adults and children (
12 years and older)
Patients with satellite instabilityhigh (MSI-H)
Insufficient repair or mismatch (dMMR)
Metastasis of colorectal cancer (CRC)
This has progressed after treatment with fluizide, platinum, and elitikang.
Based on the overall response rate and response duration, the instruction is approved with accelerated approval.
The continued approval of this indication may depend on the validation and description of the clinical benefits in the validation trial. OPDIVO^® (nivolumab)
Combine YERVOY ^®(ipilimumab)
For the treatment of adults and children aged 12 and over with microsatellite instabilityhigh (MSI-H)
Insufficient repair or mismatch (dMMR)
Metastasis of colorectal cancer (CRC)
This has progressed after treatment with fluizide, platinum, and elitikang.
According to the overall response rate and response duration, the instruction is approved with accelerated approval.
Continuing to approve this indication may be an accidental result of verifying and describing clinical benefits in the validation trial. OPDIVO^® (nivolumab)
For the treatment of liver cancer patients (HCC)
I have been treated with sorafini before.
Depending on the tumor response rate and response persistence, this indication is approved with accelerated approval.
The continued approval of this indication may depend on the validation and description of the clinical benefits in the validation trial. OPDIVO^® (nivolumab)
Used for adjuvant therapy in patients with melanoma undergoing complete resection, including lymph node or metastatic disease.
Important security information tips: immunization-
Mediated adverse reactions can lead to severe and fatal immune responses
Adverse reactions mediated. Theseimmune-
The mediated response may involve any organ system;
However, the most common severe immunization
The adverse reactions mediated by the disease are: Xiaoyan, hepatitis, dermatitis (
Including toxic skin necrosis)
Neuropathy and endocrine disease
Most of these immunizations
The mediating reaction of the initial manifestation during the treatment;
However, within a few weeks and months after YERVOY stopped, a few happened.
To evaluate whether the patient has symptoms and signs of enteritis, dermatitis, neuropathy and endocrine diseases, and to evaluate clinical chemistry including liver function tests (LFTs)
Stimulating hormone (ACTH)
Levels and thyroid function tests before baseline and each dose.
YERVOY permanent stop and start-up system high quality
Dose steroid therapy for severe immunization
Mediated ReactionImmune-
Pneumonia can cause immunity-
Induced pneumonia
Fatal cases have been reported.
The patient\'s signs of radiation imaging and symptoms of pneumonia were monitored.
Severe pneumonia of grade 2 or above was treated with testosterone.
Level 3 or level 4 is permanently stopped and level 2 is permanently stopped.
In patients treated with OPDIVO single drug, immunization-
Pneumonia has been induced. Immune-
3 intermediary pneumonia. 1% (61/1994)of patients.
In patients receiving OPDIVO 1 mg/kg, immunization-
6% initiation of pneumonia (25/407)ofpatients.
In patients with RCC voy 1 mg/kg who received OPDIVO 3 mg/kg, immunization-
There were 4 cases of pneumonia. 4% (24/547)of patients. InMSI-
Accept OPDIVO 3 mg/kg, immune voy 1 mg/kg, immunization-
In one case, pneumonia was induced. 7% (2/119)of patients.
In Checkmate 205 and 039, pneumonia, including lung clearance disease, occurred at 6. 0% (16/266)
Patients receiving OPDIVO. Immune-
Intermediate pneumonia occurred in 4 cases. 9% (13/266)
Patients receiving OPDIVO: Level 3 (n=1)and Grade 2 (n=12). Immune-
E. coli can cause immunity.
Mediated inflammatory disease
Check the patient for their symptoms and signs.
Level 2 steroid use (
Duration of more than 5 days)
Colon 3 or 4
• Retain level 2 or level 3 OPDIVO single-drug treatment and permanently stop treating Grade 4 or recurrent colonitis
Startup of OPDIVO.
When administered with YERVOY, OPDIVO and YERVOY were retained for patients with Grade 2, and treatment or recurrent colonitis was permanently stopped for patients with Grade 3 or 4.
In patients treated with OPDIVO single drug, immunization-
2. the synergy of mediation. 9% (58/1994)of patients.
In patients receiving OPDIVO 1 mg/kg, immunization-
In 26% of patients, there was a mediating inflammatory disease (107/407)
Including 3 deaths.
In patients with RCC who received OPDIVO 3 mg/kg, immunization-
In 10% of patients, there was a mediating inflammatory disease (52/547)ofpatients. In MSI-
Accept OPDIVO 3 mg/kg, immune voy 1 mg/kg, immunization-
In 7% of patients, there was a mediating inflammatory disease (8/119)of patients.
In a separate Phase 3 study of yer3 mg/kg, severe life
Threatening or fatal (
7 cases of diarrhea, fever, intestinal obstruction and abdominal sign above baseline; Grade 3-5)immune-
In 34 patients, there were mediating enteritis (7%)patients.
Alimssall YERVOY-
Patients treated in the study (n=511), 5 (1%)
Intestinal perforation, 4 (0. 8%)
Death due to complications, 26 (5%)
Hospital treatment for severe intestinal inflammationImmune-
Hepatitis virus can cause immunity.
Hepatitis mediated
Regular monitoring of abnormal liver tests in patients before and during treatment.
Cortical steroids with Grade 2 or higher transaminase elevation.
For patients without liver cancer, grade 2 retains OPDIVO, and grade 3 or grade 4 permanently stops OPDIVO.
For patients with liver cancer, if AST/ALT is in the normal range at baseline and increases to> 3 times and 5 times the normal upper limit, OPDIVO and administration are retainedULN)
, If AST/ALT is> 1 andup to 3 times ULN at baseline and increases to> 5 times, ULN is increased to 10 times, if AST/ALT is> 3 times at baseline, up to 5 times ULN and increased to> 8 times, up to 10 times ULN.
If AST or ALT is increased to 10 times the increase of ULN or total bilirubin> ULN, the OPDIVO and administration of cortical steroids are permanently stopped.
Patients undergoing surgical treatment, immunization-
1. hepatitis mediated. 8% (35/1994)ofpatients.
In patients receiving OPDIVO 1 mg/kg and immune 3 mg/kg, immunization-
13% hepatitis mediated (51/407)of patients.
In patients with rcc who received OPDIVO 3 mg/kg and immune voy 1 mg/kg, immunization-
Hepatitis occurred in 7% of patients (38/547)of patients. In MSI-
Patients with H/dMMR mCRC received OPDIVO 3 mg/kg with immune 1 mg/kg, immune-
8% liver function guided by intermediary (10/119)of patients.
040, immunity-
Hepatitis mediated in 5% requiring systemic cortical steroids (8/154)
Patients receiving OPDIVO.
In a separate Phase 3 study of yer3 mg/kg, severe life
Threatening or fatal liver toxicity (
Increase of AST or ALT> 5 times of ULN or 3 times of total bilirubinations> ULN; Grade 3-5)occurred in 8 (2%)
In patients with liver failure, 0.
2% and hospitalized 0. 4%. Immune-
A separate Phase 3 study of the neural pathway mediated by Yer3 mg/kg, 1 case of fatal guilam-
1 Case of Barr syndrome (Grade 3)
The surrounding motor neuropathy was reported. Immune-
Endocrine disease can cause immune response.
Immune-mediated hyp inflammation
Adrenaline deficiency, self-immune thyroid disease, and type 1 diabetes.
Monitor the patient\'s ophysi inflammatory symptoms and signs, thyroid function before and during treatment, and blood sugar.
As clinically shown, hormone replacement and hormone therapy for Grade 2 or greater hyp inflammation.
Grade 2 or grade 3, Grade 4 hyp inflammation stops permanently.
Grade 3 or grade 4 cortical steroids.
Level 2 retention, level 3 or level 4 adrenaline deficiency stop permanently.
Taking hormones-
Alternative treatment for hypothyroidism
Initiate medical management to control hypothyroidism.
Suspension of OPDIVOfor level 3 and permanent cessation of treatment for Level 4 elevated blood sugar.
In patients treated with OPDIVO single drug, hyp fever occurred at 0. 6%(12/1994)of patients.
Hyp inflammation occurred in 9% of patients receiving OPDIVO 1 mg/kg and yer3 mg/kg (36/407)of patients.
In patients with RCC who received OPDIVO 3 mg/kg and YERVOY 1 mg/kg, hyp fever occurred at 4. 6%(25/547)of patients. In MSI-
Patients with H/dMMR mCRC who received OPDIVO 3 mg/kg and immune voy 1 mg/kg, immune-
3. hyp inflammation is mediated. 4% (4/119)ofpatients.
In 1% of patients treated with OPDIVO alone, there was a lack of adrenaline (20/1994)of patients.
Of the patients who received OPDIVO 1 mg/kg and yer3 mg/kg, 5% showed a lack of adrenaline (21/407)ofpatients.
In the RCC patients who received OPDIVO 3 mg/kg and YERVOY 1 mg/kg, 7% showed an adrenaline deficiency (41/547)of patients. In MSI-
In patients with H/dMMR mcrc who received OPDIVO 3 mg/kg and YERVOY 1 mg/kg, adrenaline deficiency occurred over 5 years. 9% (7/119)of patients.
In patients treated with OPDIVOmonotherapy, a decrease in thyroid function or a hypothyroidism results in a 9% reduction in thyroid function (171/1994)of patients.
2. hypothyroidism occurs. 7%(54/1994)
Patients treated with OPDIVO single drug.
In 22% of patients treated with yer33 mg/kg 1 mg/kg, there was a decrease in thyroid function or a decrease in thyroid function caused by hypothyroidism (89/407)of patients.
8% (34/407)
The patient received this OPDIVO dose with YERVOY.
In rcc patients receiving OPDIVO 3 mg/kg and YERVOY 1 mg/kg, 22% developed hypothyroidism-induced positive yro inflammation (119/547)of patients.
The occurrence of hyperthyroid disease is 12% (66/547)
Patients who received this dose of opdivo with YERVOY. In MSI-
In patients with H/dMMR mCRC who received OPDIVO 3 mg/kg and yer1 1 mg/kg, hypothyroidism or hypothyroidism resulted in 15% of hypothyroidism (18/119)of patients.
The occurrence of hyperthyroid disease is 12% (14/119)of patients.
In patients treated with OPDIVO alone, diabetes occurred at 0. 9% (17/1994)of patients.
In patients who received OPDIVO 1 mg/kg and yer3 mg/kg, diabetes occurred at 1. 5% (6/407)of patients.
In patients with RCC who received OPDIVO 3 mg/kg and YERVOY 1 mg/kg, diabetes occurred in 2. 7%(15/547)of patients.
In a separate Phase 3 study of yer3 mg/kg, serious life-threatening
Threat immunity
Endocrine Disease (
Need to be hospitalized, emergency medical intervention or interfere with daily life activities; Grade 3-4)occurred in 9 (1. 8%)patients.
All 9 patients had functional decline, and some were accompanied by other endocrine diseases such as adrenaline deficiency, hypothyroidism and hypothyroidism.
Of the 9 patients, 6 were hospitalized for serious endocrine diseases. Immune-
Immune-induced nephritis and renal dysfunction-
Inflammatory disease mediated
Patients were regularly monitored for elevated serum creatinine before and during treatment.
Grade 2 hormone
Elevated Serum incoside.
Level 2 or level 3 retains OPDIVO and permanently stops level 4 to increase serum incoside.
In patients treated with OPDIVO single drug, immunization-
Kidney damage and kidney function damage 1. 2% (23/1994)of patients.
In-patient patients who received OPDIVO 1 mg/kg took immune 3 mg/kg and were immune-
Kidney damage and kidney function damage 2. 2% (9/407)of patients.
In patients with rcc who received OPDIVO 3 mg/kg and immune voy 1 mg/kg, immunization-
There were 4 cases of renal damage and renal damage. 6% (25/547)of patients. InMSI-
Accept OPDIVO 3 mg/kg, immune voy 1 mg/kg, immunization-
1. the occurrence of mediated nephritis and renal dysfunction. 7% (2/119)ofpatients. Immune-
Immune response can be caused by skin adverse reactions
Mediated rash including Stevens
Johnson syndrome (SJS)
And necrosis of the toxic skin (TEN)
Some fatal cases.
Grade 3 or grade 4 rashes are treated with cortical steroids.
Grade 3 retention, Grade 4 rash stop permanently.
For symptoms or signs of SJS or TEN, stop OPDIVO and have the patient receive specialized care for evaluation and treatment;
If confirmed, stop permanently.
Patients undergoing surgical treatment, immunization-
9% introduction of rash (171/1994)of patients.
In-patient patients who received OPDIVO 1 mg/kg took immune 3 mg/kg and were immune-
The mediated rash occurred at 22. 6% (92/407)of patients.
In patients with RCC voy 1 mg/kg who received OPDIVO 3 mg/kg, immunization-
The rash was mediated in 16 cases. 6% (91/547)ofpatients. In MSI-
Accept OPDIVO 3 mg/kg, immune voy 1 mg/kg, immunization-
14% introduction of rash (17/119)of patients.
In a separate Phase 3 study of yer3 mg/kg, severe life
Threatening or lethal immunity
Mediated dermatitis (eg, Stevens-
Johnson syndrome, toxic necrosis of the skin or rash, with full-thickness dermal ulcer or necrosis, blisters or bleeding; Grade 3-5)
occurred in 13(2. 5%)patients. 1 (0. 2%)
The patient died of toxic necrosis and dissolution of the skin.
One case of serious dermatitis needs to be hospitalized. Immune-
Mediated brain bridge can cause immune response
Brain disease mediated
The assessment of patients with neurological symptoms may include, but is not limited to, consultations with eye physicians, brain MRI, and lumbar puncture physicians.
Keep OPDIVO in new patients
Moderate to severe nervous system signs or symptoms occur and other causes are assessed and excluded.
If other causes are excluded, take steroids and stop OPDIVO permanently for immunization-
Mediatedencephalitis.
In patients treated with OPDIVO single drug, 0. 2% (3/1994)of patients.
After seven years of age, a patient developed a fatal marginal meningitis.
Despite deactivating OPDIVO and taking steroids, 2 months of exposure remained.
Polio occurred in one patient treated with OPDIVO 1 mg/kg and YERVOY 3 mg/kg (0. 2%)after 1.
Seven months of exposure.
One person accepted OPDIVO 3 mg/kg and YERVOY 1 mg/kg (0. 2%)
About four months after exposure.
Dengue fever happened in an MSI-
H/dMMR in MCRC patients (0. 8%)
After 15 days of exposure, OPDIVO 3 mg/kg was accepted with yer1 1 mg/kg. Other Immune-
• Permanently stop or retain OPDIVO based on the severity of the adverse reactions, and give a high dose
Dose of cortical steroids, start the hormone if appropriate-
Alternative treatment.
Throughout the clinical trial of YERVOY OPDIVOmonotherapy, the following clinicallysignificant immunity
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