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More than bisected (53%) of patients advised with Opdivo added Yervoy survived to four years, with average all-embracing adaptation (OS) not yet reached

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Higher admeasurement of patients advised with aggregate were treatment-free at four years compared to those advised with Opdivo or Yervoy alone

Results represent the longest aftereffect to date for patients who accustomed a aggregate of allowed checkpoint inhibitors in a Phase 3, randomized, controlled trial

Bristol-Myers Squibb Aggregation (BMY) today appear four-year abstracts from the Phase 3 CheckMate -067 analytic balloon – the longest aftereffect to date – which continues to authenticate durable, abiding adaptation allowances with the first-line aggregate of Opdivo (nivolumab) and Yervoy (ipilimumab), against Yervoy alone, in patients with avant-garde melanoma. With a minimum aftereffect of 48 months, four-year all-embracing adaptation ante were 53% for the Opdivo added Yervoy combination, 46% for Opdivo alone, and 30% for Yervoy alone. Additionally, the allotment of patients experiencing a complete acknowledgment accept connected to access with complete acknowledgment ante of 21% for Opdivo added Yervoy, 18% for Opdivo alone, and 5% for Yervoy alone.

In addition, after-effects of an assay of patients who were animate at the time of the four-year assay showed that a college admeasurement of patients were treatment-free (i.e., off abstraction assay and chargeless of systemic consecutive therapy) in the aggregate accumulation (71%) compared with the monotherapy groups (50% for Opdivo and 39% for Yervoy). The assurance contour for Opdivo added Yervoy in CheckMate -067 at four years was constant with above-mentioned findings, with no new assurance signals and no added treatment-related deaths.

Data from CheckMate -067 (Presentation #LBA44) will be featured in an articulate presentation at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany, October 19-23, with accompanying advertisement in The Lancet Oncology.

“These four-year after-effects from CheckMate -067, which represent the longest aftereffect to date for patients accepting aggregate assay with nivolumab and ipilimumab, enhance our compassionate of the abeyant abiding adaptation allowances of aggregate therapy, behindhand of PD-L1 announcement levels, to activity this advancing anatomy of melanoma,” said CheckMate -067 investigator F. Stephen Hodi, M.D., administrator of the Melanoma Centermost at Dana-Farber Blight Institute, and investigator at the Ludwig Centermost at Harvard. “To the best of our knowledge, we accept not apparent a 53% all-embracing adaptation amount with any accessible assay at four years of aftereffect in a randomized setting.”

“These latest after-effects from CheckMate -067 accommodate added abutment of the abiding accurate account for accumulation Opdivo and Yervoy for the assay of avant-garde melanoma,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “This abstraction advances our mission of compassionate how we can best accouter the body’s allowed arrangement to activity this advancing anatomy of blight and accommodate healthcare professionals and patients with a abiding and safe assay option.”

CheckMate -067 is a Phase 3, double-blind, randomized balloon that evaluated the aggregate of Opdivo plus Yervoy or Opdivo monotherapy versus Yervoy monotherapy in 945 patients with ahead basic avant-garde melanoma. Patients in the aggregate accumulation (n=314) received Opdivo 1 mg/kg plus Yervoy 3 mg/kg (Q3W) for four doses followed by Opdivo 3 mg/kg every two weeks (Q2W). Patients in the Opdivo monotherapy accumulation (n=316) received Opdivo 3 mg/kg Q2W added placebo. Patients in the Yervoy monotherapy accumulation (n=315) received Yervoy 3 mg/kg every three weeks for four doses added placebo. Patients were advised until progression or unacceptable baneful effects. All-embracing adaptation (OS) and progression-free adaptation (PFS) were co-primary endpoints of the trial. Secondary endpoints included cold acknowledgment ante (ORR), ability by bump PD-L1 announcement akin and safety.

ORR remained constant with the above-mentioned three-year assay and were 58% for the combination, 45% for Opdivo abandoned and 19% for Yervoy alone; however, the best ORRs added hardly with complete responses of 21%, 18% and 5%, respectively. The hazard arrangement (HR) for progression-free adaptation (PFS) for the aggregate against Yervoy abandoned was 0.42 (95% Confidence Interval [CI]: 0.35-0.51; p: <0.0001) and for Opdivo abandoned against Yervoy abandoned was 0.53 (95% CI: 0.44-0.64; p: <0.0001).

Overall, adaptation outcomes advantaged the Opdivo-containing groups over Yervoy for all subgroups evaluated, and a anecdotic assay showed bigger adaptation ante for the aggregate of Opdivo and Yervoy compared with Opdivo monotherapy aloft subgroups. Four-year adaptation ante for patients with tumors accepting a BRAF alteration were 62% for the combination, 50% for Opdivo, and 33% for Yervoy, and those for patients with wild-type BRAF were 49%, 45%, and 28%, respectively. In a anecdotic allegory for patients with a BRAF mutation, the aggregate provided added account than Opdivo abandoned with a PFS hazard arrangement of 0.62 (95% CI: 0.44-0.88) and an OS hazard arrangement of 0.70 (95% CI: 0.46-1·07).

At this four-year analysis, treatment-related adverse contest were constant with those ahead appear and occurred in 300 (96%) patients in the aggregate group, 270 (86%) patients in the Opdivo group, and 268 (86%) patients in the Yervoy group; brand 3/4 adverse contest occurred in 185 (59%), 70 (22%), and 86 (28%) patients, respectively.

About Metastatic Melanoma

Melanoma is a anatomy of bark blight characterized by the amoral beforehand of pigment-producing beef (melanocytes) amid in the skin. Metastatic melanoma is the deadliest anatomy of the ache and occurs aback blight spreads aloft the apparent of the bark to added organs. The accident of melanoma has been accretion steadily for the aftermost 30 years. In the United States, 91,270 new diagnoses of melanoma and added than 9,320 accompanying deaths are estimated for 2018. Globally, the Apple Bloom Organization estimates that by 2035, melanoma accident will ability 424,102, with 94,308 accompanying deaths. Melanoma is mostly curable aback advised in its aboriginal stages. However, patients in the United States diagnosed with avant-garde melanoma classified as Stage IV historically accept a five-year adaptation amount of 15% to 20% and 10-year adaptation of about 10% to 15%.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the centermost of aggregate we do. Our eyes for the approaching of blight affliction is focused on researching and developing transformational medicines, including Immuno-Oncology (I-O) ameliorative approaches, for hard-to-treat cancers that could potentially beforehand outcomes for these patients.

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We are arch the chip accurate compassionate of both bump corpuscle and allowed arrangement pathways, through our all-encompassing portfolio of investigational compounds and accustomed agents. Our differentiated analytic development affairs is belief ample accommodating populations aloft added than 50 types of cancers with 24 clinical-stage molecules advised to ambition altered allowed arrangement pathways. Our abysmal ability and avant-garde analytic balloon designs position us to beforehand the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies aloft assorted tumors and potentially bear the aing beachcomber of therapies with a faculty of urgency. We additionally abide to avant-garde analysis that will advice facilitate a added compassionate of the role of allowed biomarkers and how a patient’s bump analysis can be acclimated as a adviser for assay decisions throughout their journey.

We accept authoritative the affiance of transformational medicines like I-O therapies a absoluteness for the abounding patients who may account from these therapies requires not abandoned addition on our allotment but additionally aing accord with arch experts in the field. Our partnerships with academia, government, advancement and biotech companies abutment our aggregate ambition of accouterment new assay options to beforehand the standards of analytic practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) allowed checkpoint inhibitor that is advised to abnormally accouter the body’s own allowed arrangement to advice restore anti-tumor allowed response. By harnessing the body’s own allowed arrangement to activity cancer, Opdivo has become an important assay advantage aloft assorted cancers.

Opdivo’s arch all-around development affairs is based on Bristol-Myers Squibb’s accurate ability in the acreage of Immuno-Oncology, and includes a ample ambit of analytic trials aloft all phases, including Phase 3, in a array of bump types. To date, the Opdivo clinical development affairs has enrolled added than 25,000 patients. The Opdivo trials accept contributed to accepting a added compassionate of the abeyant role of biomarkers in accommodating care, decidedly apropos how patients may account from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the aboriginal PD-1 allowed checkpoint inhibitor to accept authoritative approval anywhere in the world. Opdivo is currently accustomed in added than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination dieting was the aboriginal Immuno-Oncology aggregate to accept authoritative approval for the assay of metastatic melanoma and is currently accustomed in added than 50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO®

OPDIVO® (nivolumab) as a distinct abettor is adumbrated for the assay of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This adumbration is accustomed beneath accelerated approval based on progression-free survival. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials.

OPDIVO® (nivolumab) as a distinct abettor is adumbrated for the assay of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in aggregate with YERVOY® (ipilimumab), is adumbrated for the assay of patients with unresectable or metastatic melanoma. This adumbration is accustomed beneath accelerated approval based on progression-free survival. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials.

OPDIVO® (nivolumab) is adumbrated for the assay of patients with metastatic non-small corpuscle lung blight (NSCLC) with progression on or afterwards platinum-based chemotherapy. Patients with EGFR or ALK genomic bump aberrations should accept ache progression on FDA-approved assay for these aberrations above-mentioned to accepting OPDIVO.

OPDIVO® (nivolumab) is adumbrated for the assay of patients with metastatic baby corpuscle lung blight (SCLC) with progression afterwards platinum-based chemotherapy and at atomic one added band of therapy. This adumbration is accustomed beneath accelerated approval based on all-embracing acknowledgment amount and continuance of response. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in acknowledging trials.

OPDIVO® (nivolumab) is adumbrated for the assay of patients with avant-garde renal corpuscle blight (RCC) who accept accustomed above-mentioned anti-angiogenic therapy.

OPDIVO® (nivolumab), in aggregate with YERVOY® (ipilimumab), is adumbrated for the assay of patients with average or poor risk, ahead basic avant-garde renal corpuscle blight (RCC).

OPDIVO® (nivolumab) is adumbrated for the assay of developed patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed afterwards autologous hematopoietic axis corpuscle transplantation (HSCT) and brentuximab vedotin or afterwards 3 or added curve of systemic assay that includes autologous HSCT. This adumbration is accustomed beneath accelerated approval based on all-embracing acknowledgment rate. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in acknowledging trials.

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OPDIVO® (nivolumab) is adumbrated for the assay of patients with alternate or metastatic squamous corpuscle blight of the arch and close (SCCHN) with ache progression on or afterwards platinum-based therapy.

OPDIVO® (nivolumab) is adumbrated for the assay of patients with locally avant-garde or metastatic urothelial blight who accept ache progression during or afterward platinum-containing chemotherapy or accept ache progression aural 12 months of neoadjuvant or accessory assay with platinum-containing chemotherapy. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and continuance of response. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in acknowledging trials.

OPDIVO® (nivolumab), as a distinct agent, is adumbrated for the assay of developed and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or conflict adjustment amiss (dMMR) metastatic colorectal blight (CRC) that has progressed afterward assay with a fluoropyrimidine, oxaliplatin, and irinotecan. This adumbration is accustomed beneath accelerated approval based on all-embracing acknowledgment amount and continuance of response. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in acknowledging trials.

OPDIVO® (nivolumab), in aggregate with YERVOY® (ipilimumab), is adumbrated for the assay of adults and pediatric patients 12 years and earlier with microsatellite instability-high (MSI-H) or conflict adjustment amiss (dMMR) metastatic colorectal blight (CRC) that has progressed afterward assay with a fluoropyrimidine, oxaliplatin, and irinotecan. This adumbration is accustomed beneath accelerated approval based on all-embracing acknowledgment amount and continuance of response. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in acknowledging trials.

OPDIVO® (nivolumab) is adumbrated for the assay of patients with hepatocellular blight (HCC) who accept been ahead advised with sorafenib. This adumbration is accustomed beneath accelerated approval based on bump acknowledgment amount and backbone of response. Connected approval for this adumbration may be accidental aloft analysis and description of analytic account in the acknowledging trials.

OPDIVO® (nivolumab) is adumbrated for the accessory assay of patients with melanoma with captivation of lymph nodes or metastatic ache who accept undergone complete resection.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can aftereffect in astringent and baleful immune-mediated adverse reactions. These immune-mediated reactions may absorb any agency system; however, the best accepted astringent immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including baneful epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially embodied during treatment; however, a boyhood occurred weeks to months afterwards cessation of YERVOY.

Assess patients for signs and affection of enterocolitis, dermatitis, neuropathy, and endocrinopathy, and appraise analytic chemistries including alarmist activity tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid activity tests, at baseline and afore anniversary dose.

Permanently abandon YERVOY and admit systemic high-dose corticosteroid assay for astringent immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can account immune-mediated pneumonitis. Baleful cases accept been reported. Monitor patients for signs with radiographic imaging and for affection of pneumonitis. Administrate corticosteroids for Brand 2 or added astringent pneumonitis. Assuredly abandon for Brand 3 or 4 and abstain until resolution for Brand 2. In patients accepting OPDIVO monotherapy, baleful cases of immune-mediated pneumonitis accept occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients accepting OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients accepting OPDIVO: Brand 3 (n=1) and Brand 2 (n=12).

Immune-Mediated Colitis

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OPDIVO can account immune-mediated colitis. Monitor patients for signs and affection of colitis. Administrate corticosteroids for Brand 2 (of added than 5 canicule duration), 3, or 4 colitis. Abstain OPDIVO monotherapy for Brand 2 or 3 and assuredly abandon for Brand 4 or alternate colitis aloft re-initiation of OPDIVO. Aback administered with YERVOY, abstain OPDIVO and YERVOY for Brand 2 and assuredly abandon for Brand 3 or 4 or alternate colitis. In patients accepting OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three baleful cases. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a abstracted Phase 3 abstraction of YERVOY 3 mg/kg, severe, life-threatening, or baleful (diarrhea of ≥7 stools aloft baseline, fever, ileus, peritoneal signs; Brand 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Aloft all YERVOY-treated patients in that abstraction (n=511), 5 (1%) developed belly perforation, 4 (0.8%) died as a aftereffect of complications, and 26 (5%) were ailing for astringent enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can account immune-mediated hepatitis. Monitor patients for aberrant alarmist tests above-mentioned to and periodically during treatment. Administrate corticosteroids for Brand 2 or greater transaminase elevations. For patients afterwards HCC, abstain OPDIVO for Brand 2 and assuredly abandon OPDIVO for Brand 3 or 4. For patients with HCC, abstain OPDIVO and administrate corticosteroids if AST/ALT is aural accustomed banned at baseline and increases to >3 and up to 5 times the high absolute of accustomed (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Assuredly abandon OPDIVO and administrate corticosteroids if AST or ALT increases to >10 times the ULN or absolute bilirubin increases >3 times the ULN. In patients accepting OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis astute systemic corticosteroids occurred in 5% (8/154) of patients accepting OPDIVO.

In a abstracted Phase 3 abstraction of YERVOY 3 mg/kg, severe, life-threatening, or baleful hepatotoxicity (AST or ALT elevations >5x the ULN or absolute bilirubin elevations >3x the ULN; Brand 3-5) occurred in 8 (2%) patients, with baleful hepatic abortion in 0.2% and analysis in 0.4%.

Immune-Mediated Neuropathies

In a abstracted Phase 3 abstraction of YERVOY 3 mg/kg, 1 case of baleful Guillain-Barré affection and 1 case of astringent (Grade 3) borderline motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can account immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and affection of hypophysitis, signs and affection of adrenal insufficiency, thyroid activity above-mentioned to and periodically during treatment, and hyperglycemia. Administrate hormone backup as clinically adumbrated and corticosteroids for Brand 2 or greater hypophysitis. Abstain for Brand 2 or 3 and assuredly abandon for Brand 4 hypophysitis. Administrate corticosteroids for Brand 3 or 4 adrenal insufficiency. Abstain for Brand 2 and assuredly abandon for Brand 3 or 4 adrenal insufficiency. Administrate hormone-replacement assay for hypothyroidism. Admit medical administering for ascendancy of hyperthyroidism. Abstain OPDIVO for Brand 3 and assuredly abandon for Brand 4 hyperglycemia.

In patients accepting OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients accepting OPDIVO monotherapy, adrenal dearth occurred in 1% (20/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal dearth occurred in 5% (21/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal dearth occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal dearth occurred in 5.9% (7/119) of patients. In patients accepting OPDIVO monotherapy, hypothyroidism or thyroiditis consistent in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients accepting OPDIVO monotherapy. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis consistent in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients accepting this dosage of OPDIVO with YERVOY. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis consistent in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients accepting this dosage of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis consistent in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients accepting OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a abstracted Phase 3 abstraction of YERVOY 3 mg/kg, astringent to life-threatening immune-mediated endocrinopathies (requiring hospitalization, burning medical intervention, or interfering with activities of circadian living; Brand 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had added accessory endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were ailing for astringent endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can account immune-mediated nephritis. Monitor patients for animated serum creatinine above-mentioned to and periodically during treatment. Administrate corticosteroids for Grades 2-4 added serum creatinine. Abstain OPDIVO for Brand 2 or 3 and assuredly abandon for Brand 4 added serum creatinine. In patients accepting OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Bark Adverse Reactions and Dermatitis

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OPDIVO can account immune-mediated rash, including Stevens-Johnson affection (SJS) and baneful epidermal necrolysis (TEN), some cases with baleful outcome. Administrate corticosteroids for Brand 3 or 4 rash. Abstain for Brand 3 and assuredly abandon for Brand 4 rash. For affection or signs of SJS or TEN, abstain OPDIVO and accredit the accommodating for specialized affliction for appraisal and treatment; if confirmed, assuredly discontinue. In patients accepting OPDIVO monotherapy, immune-mediated adventurous occurred in 9% (171/1994) of patients. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated adventurous occurred in 22.6% (92/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated adventurous occurred in 16.6% (91/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated adventurous occurred in 14% (17/119) of patients.

In a abstracted Phase 3 abstraction of YERVOY 3 mg/kg, severe, life-threatening, or baleful immune-mediated dermatitis (eg, Stevens-Johnson syndrome, baneful epidermal necrolysis, or adventurous complicated by abounding array dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Brand 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) accommodating died as a aftereffect of baneful epidermal necrolysis. 1 added accommodating adapted analysis for astringent dermatitis.

Immune-Mediated Encephalitis

OPDIVO can account immune-mediated encephalitis. Evaluation of patients with neurologic affection may include, but not be bound to, appointment with a neurologist, academician MRI, and lumbar puncture. Abstain OPDIVO in patients with new-onset abstinent to astringent neurologic signs or affection and appraise to aphorism out added causes. If added etiologies are disqualified out, administrate corticosteroids and assuredly abandon OPDIVO for immune-mediated encephalitis. In patients accepting OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Baleful limbic encephalitis occurred in one accommodating afterwards 7.2 months of acknowledgment admitting cessation of OPDIVO and administering of corticosteroids. Encephalitis occurred in one accommodating accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) afterwards 1.7 months of exposure. Encephalitis occurred in one RCC accommodating accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) afterwards about 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC accommodating (0.8%) accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg afterwards 15 canicule of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, assuredly abandon or abstain OPDIVO, administrate high-dose corticosteroids, and, if appropriate, admit hormone-replacement therapy. Aloft analytic trials of OPDIVO monotherapy or in aggregate with YERVOY, the afterward clinically cogent immune-mediated adverse reactions, some with baleful outcome, occurred in <1.0% of patients accepting OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens assumption paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic anarchic acknowledgment syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic syndrome.

If uveitis occurs in aggregate with added immune-mediated adverse reactions, accede a Vogt-Koyanagi-Harada-like syndrome, which has been empiric in patients accepting OPDIVO and may crave assay with systemic steroids to abate the accident of abiding eyes loss.

Infusion Reactions

OPDIVO can account astringent beverage reactions, which accept been appear in <1.0% of patients in analytic trials. Abandon OPDIVO in patients with Grade 3 or 4 beverage reactions. Interrupt or apathetic the amount of beverage in patients with Grade 1 or 2. In patients accepting OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a abstracted abstraction in which patients accustomed OPDIVO monotherapy as a 60-minute beverage or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, accomplished adverse reactions aural 48 hours of beverage that led to dosage delay, abiding cessation or denial of OPDIVO. In patients accepting OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In RCC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients accepting OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients.

Complications of Allogeneic HSCT afterwards OPDIVO

Complications, including baleful events, occurred in patients who accustomed allogeneic HSCT afterwards OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT afterwards alternate OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT afterwards OPDIVO. Five deaths occurred in the ambience of astringent or adverse GVHD. Brand 3 or college astute GVHD was appear in 29% (5/17) of patients. Hyperacute GVHD was appear in 20% (n=2) of patients. A steroid-requiring delirious syndrome, afterwards an articular communicable cause, was appear in 35% (n=6) of patients. Two cases of encephalitis were reported: Brand 3 (n=1) lymphocytic encephalitis afterwards an articular communicable cause, and Brand 3 (n=1) doubtable viral encephalitis. Hepatic veno-occlusive ache (VOD) occurred in one patient, who accustomed reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Added cases of hepatic VOD afterwards reduced-intensity conditioned allogeneic HSCT accept additionally been appear in patients with lymphoma who accustomed a PD-1 receptor blocking antibiotic afore transplantation. Cases of baleful hyperacute GVHD accept additionally been reported. These complications may activity admitting amid assay amid PD-1 barricade and allogeneic HSCT.

Follow patients carefully for aboriginal affirmation of transplant-related complications such as hyperacute GVHD, astringent (Grade 3 to 4) astute GVHD, steroid-requiring delirious syndrome, hepatic VOD, and added immune-mediated adverse reactions, and arbitrate promptly.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can account fetal abuse aback administered to a abundant woman. Admonish abundant women of the abeyant accident to a fetus. Admonish females of changeable abeyant to use able contraception during assay with an OPDIVO- or YERVOY- absolute dieting and for at atomic 5 months afterwards the aftermost dosage of OPDIVO.

Lactation

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Breastfeeding assessment instruments and their use in clinical practice – lactation assessment form | lactation assessment form

It is not accepted whether OPDIVO or YERVOY is present in animal milk. Because abounding drugs, including antibodies, are excreted in animal milk and because of the abeyant for austere adverse reactions in nursing breed from an OPDIVO-containing regimen, admonish women to abandon feeding during treatment. Admonish women to abandon feeding during assay with YERVOY and for 3 months afterward the final dose.

Serious Adverse Reactions

In Checkmate 037, austere adverse reactions occurred in 41% of patients accepting OPDIVO (n=268). Brand 3 and 4 adverse reactions occurred in 42% of patients accepting OPDIVO. The best accepted Brand 3 and 4 adverse biologic reactions appear in 2% to <5% of patients accepting OPDIVO were belly pain, hyponatremia, added aspartate aminotransferase, and added lipase. In Checkmate 066, austere adverse reactions occurred in 36% of patients accepting OPDIVO (n=206). Brand 3 and 4 adverse reactions occurred in 41% of patients accepting OPDIVO. The best accepted Brand 3 and 4 adverse reactions appear in ≥2% of patients accepting OPDIVO were gamma-glutamyltransferase access (3.9%) and diarrhea (3.4%). In Checkmate 067, austere adverse reactions (73% and 37%), adverse reactions arch to abiding cessation (43% and 14%) or to dosing delays (55% and 28%), and Brand 3 or 4 adverse reactions (72% and 44%) all occurred added frequently in the OPDIVO added YERVOY arm (n=313) about to the OPDIVO arm (n=313). The best accepted (≥10%) austere adverse reactions in the OPDIVO added YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and agitation (10% and 0.6%). In Checkmate 017 and 057, austere adverse reactions occurred in 46% of patients accepting OPDIVO (n=418). The best accepted austere adverse reactions appear in ≥2% of patients accepting OPDIVO were pneumonia, pulmonary emism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, austere adverse reactions occurred in 45% of patients accepting OPDIVO (n=245). The best accepted austere adverse reactions appear in at atomic 2% of patients accepting OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. In Checkmate 025, austere adverse reactions occurred in 47% of patients accepting OPDIVO (n=406). The best accepted austere adverse reactions appear in ≥2% of patients were astute branch injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, austere adverse reactions occurred in 59% of patients accepting OPDIVO added YERVOY and in 43% of patients accepting sunitinib. The best accepted austere adverse reactions appear in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, astute branch injury, dyspnea, adrenal insufficiency, and colitis; in patients advised with sunitinib, they were pneumonia, pleural effusion, and dyspnea. In Checkmate 205 and 039, adverse reactions arch to cessation occurred in 7% and dosage delays due to adverse reactions occurred in 34% of patients (n=266). Austere adverse reactions occurred in 26% of patients. The best accepted austere adverse reactions appear in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes added than ache progression: 3 from adverse reactions aural 30 canicule of the aftermost OPDIVO dose, 2 from infection 8 to 9 months afterwards commutual OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, austere adverse reactions occurred in 49% of patients accepting OPDIVO (n=236). The best accepted austere adverse reactions appear in ≥2% of patients accepting OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory amplitude infection, and sepsis. In Checkmate 275, austere adverse reactions occurred in 54% of patients accepting OPDIVO (n=270). The best accepted austere adverse reactions appear in ≥2% of patients accepting OPDIVO were urinary amplitude infection, sepsis, diarrhea, baby civil obstruction, and accepted concrete bloom deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients accepting OPDIVO with YERVOY, austere adverse reactions occurred in 47% of patients. The best accepted austere adverse reactions appear in ≥2% of patients were colitis/diarrhea, hepatic events, belly pain, astute branch injury, pyrexia, and dehydration. In Checkmate 040, austere adverse reactions occurred in 49% of patients (n=154). The best accepted austere adverse reactions appear in ≥2% of patients were pyrexia, ascites, aback pain, accepted concrete bloom deterioration, belly pain, and pneumonia. In Checkmate 238, Brand 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The best accepted Brand 3 and 4 adverse reactions appear in ≥2% of OPDIVO-treated patients were diarrhea and added lipase and amylase. Austere adverse reactions occurred in 18% of OPDIVO-treated patients.

Common Adverse Reactions

In Checkmate 037, the best accepted adverse acknowledgment (≥20%) appear with OPDIVO (n=268) was adventurous (21%). In Checkmate 066, the best accepted adverse reactions (≥20%) appear with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal affliction (32% vs 25%), adventurous (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the best accepted (≥20%) adverse reactions in the OPDIVO added YERVOY arm (n=313) were fatigue (59%), adventurous (53%), diarrhea (52%), abhorrence (40%), agitation (37%), airsickness (28%), and dyspnea (20%). The best accepted (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), adventurous (40%), diarrhea (31%), and abhorrence (28%). In Checkmate 017 and 057, the best accepted adverse reactions (≥20%) in patients accepting OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 032, the best accepted adverse reactions (≥20%) in patients accepting OPDIVO (n=245) were fatigue (45%), decreased appetence (27%), musculoskeletal affliction (25%), dyspnea (22%), abhorrence (22%), diarrhea (21%), ache (20%), and ahem (20%). In Checkmate 025, the best accepted adverse reactions (≥20%) appear in patients accepting OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), ahem (34% vs 38%), abhorrence (28% vs 29%), adventurous (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), ache (23% vs 18%), decreased appetence (23% vs 30%), aback affliction (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the best accepted adverse reactions (≥20%) appear in patients advised with OPDIVO added YERVOY (n=547) vs sunitinib (n=535) were fatigue (58% vs 69%), adventurous (39% vs 25%), diarrhea (38% vs 58%), musculoskeletal affliction (37% vs 40%), pruritus (33% vs 11%), abhorrence (30% vs 43%), ahem (28% vs 25%), agitation (25% vs 17%), arthralgia (23% vs 16%), decreased appetence (21% vs 29%), dyspnea (20% vs 21%), and airsickness (20% vs 28%). In Checkmate 205 and 039, the best accepted adverse reactions (≥20%) appear in patients accepting OPDIVO (n=266) were high respiratory amplitude infection (44%), fatigue (39%), ahem (36%), diarrhea (33%), agitation (29%), musculoskeletal affliction (26%), adventurous (24%), abhorrence (20%), and pruritus (20%). In Checkmate 141, the best accepted adverse reactions (≥10%) in patients accepting OPDIVO (n=236) were ahem and dyspnea at a college accident than investigator’s choice. In Checkmate 275, the best accepted adverse reactions (≥20%) appear in patients accepting OPDIVO (n=270) were fatigue (46%), musculoskeletal affliction (30%), abhorrence (22%), and decreased appetence (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients accepting OPDIVO as a distinct agent, the best accepted adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), belly affliction (34%), abhorrence (34%), airsickness (28%), musculoskeletal affliction (28%), ahem (26%), agitation (24%), adventurous (23%), ache (20%), and high respiratory amplitude infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients accepting OPDIVO with YERVOY, the best accepted adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), agitation (36%), musculoskeletal affliction (36%), belly affliction (30%), pruritus (28%), abhorrence (26%), adventurous (25%), decreased appetence (20%), and airsickness (20%). In Checkmate 040, the best accepted adverse reactions (≥20%) in patients accepting OPDIVO (n=154) were fatigue (38%), musculoskeletal affliction (36%), belly affliction (34%), pruritus (27%), diarrhea (27%), adventurous (26%), ahem (23%), and decreased appetence (22%). In Checkmate 238, the best accepted adverse reactions (≥20%) appear in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), adventurous (35% vs 47%), musculoskeletal affliction (32% vs 27%), pruritus (28% vs 37%), cephalalgia (23% vs 31%), abhorrence (23% vs 28%), high respiratory infection (22% vs 15%), and belly affliction (21% vs 23%). The best accepted immune-mediated adverse reactions were adventurous (16%), diarrhea/colitis (6%), and hepatitis (3%). In a abstracted Phase 3 abstraction of YERVOY 3 mg/kg, the best accepted adverse reactions (≥5%) in patients who accustomed YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), adventurous (29%), and colitis (8%).

Checkmate Trials and Accommodating Populations

Checkmate 067–advanced melanoma abandoned or in aggregate with YERVOY® (ipilimumab); Checkmate 214–intermediate or poor accident avant-garde renal corpuscle blight in aggregate with YERVOY; Checkmate 142–MSI-H/dMMR metastatic colorectal cancer; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 040–hepatocellular carcinoma; Checkmate 037/066–advanced melanoma; Checkmate 017–squamous non-small corpuscle lung blight (NSCLC); Checkmate 057–non-squamous NSCLC; Checkmate 025–previously advised renal corpuscle carcinoma; Checkmate 141–squamous corpuscle blight of the arch and neck; Checkmate 275–urothelial carcinoma; Checkmate 238–adjuvant assay of melanoma.

Please see U.S. Abounding Prescribing Advice for OPDIVO and YERVOY, including Boxed WARNING apropos immune-mediated adverse reactions for YERVOY.

About the Bristol-Myers Squibb and Ono Biologic Collaboration

In 2011, through a accord acceding with Ono Biologic Co., Bristol-Myers Squibb broadcast its territorial rights to advance and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, area Ono had retained all rights to the admixture at the time. On July 23, 2014, Ono and Bristol-Myers Squibb added broadcast the companies’ cardinal accord acceding to accordingly advance and commercialize assorted immunotherapies – as distinct agents and aggregate regimens – for patients with blight in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a all-around biopharmaceutical aggregation whose mission is to discover, advance and bear avant-garde medicines that advice patients abound over austere diseases. For added advice about Bristol-Myers Squibb, appointment us at BMS.com or chase us on LinkedIn, Twitter, YouTube and Facebook.

Bristol-Myers Squibb Forward-Looking Statement

This columnist absolution contains “forward-looking statements” as that appellation is authentic in the Private Securities Litigation Reform Act of 1995 apropos the research, development and commercialization of biologic products. Such advanced statements are based on accepted expectations and absorb inherent risks and uncertainties, including factors that could delay, alter or change any of them, and could account absolute outcomes and after-effects to alter materially from accepted expectations. No advanced account can be guaranteed. Among added risks, there can be no agreement that Opdivo or Yervoy will accept authoritative approval for an added indication. Advanced statements in this columnist absolution should be evaluated calm with the abounding uncertainties that affect Bristol-Myers Squibb’s business, decidedly those articular in the cautionary factors altercation in Bristol-Myers Squibb’s Annual Report on Anatomy 10-K for the year concluded December 31, 2017 in our Quarterly Reports on Anatomy 10-Q and our Accepted Reports on Anatomy 8-K. Bristol-Myers Squibb undertakes no obligation to about amend any advanced statement, whether as a aftereffect of new information, approaching contest or otherwise.

View antecedent adaptation on businesswire.com: https://www.businesswire.com/news/home/20181022005105/en/

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