{"id":61080,"date":"2025-04-11T22:05:26","date_gmt":"2025-04-11T20:05:26","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/u-s-food-and-drug-administration-approves-opdivo-nivolumab-plus-yervoy-ipilimumab-as-a-first-line-treatment-for-unresectable-or-metastatic-hepatocellular-carcinoma\/"},"modified":"2025-04-11T22:05:26","modified_gmt":"2025-04-11T20:05:26","slug":"u-s-food-and-drug-administration-approves-opdivo-nivolumab-plus-yervoy-ipilimumab-as-a-first-line-treatment-for-unresectable-or-metastatic-hepatocellular-carcinoma","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/u-s-food-and-drug-administration-approves-opdivo-nivolumab-plus-yervoy-ipilimumab-as-a-first-line-treatment-for-unresectable-or-metastatic-hepatocellular-carcinoma\/","title":{"rendered":"U.S. Food and Drug Administration Approves Opdivo\u00ae (nivolumab) plus Yervoy\u00ae (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma"},"content":{"rendered":"
\n

\nBased on the Phase 3 CheckMate-9DW trial, <\/i>Opdivo plus <\/i>Yervoy demonstrated a statistically significant overall survival benefit compared to investigator\u2019s choice of lenvatinib or sorafenib1<\/sup><\/i><\/b>\n<\/p>\n

\nIn the trial, 38% of patients were still alive at 3 years with this dual immunotherapy vs. 24% with the comparator arm1<\/sup><\/i><\/b>\n<\/p>\n

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY<\/a> #BMS<\/a>—Bristol Myers Squibb<\/a> (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo<\/i>\u00ae <\/i><\/sup>(nivolumab) plus Yervoy<\/i>\u00ae<\/sup> (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.1,2<\/sup> This approval is based on the results from the global Phase 3 randomized, open-label CheckMate-9DW trial evaluating the combination of Opdivo <\/i>plus Yervoy <\/i>compared to investigator\u2019s choice of tyrosine kinase inhibitor monotherapy (lenvatinib or sorafenib) in patients with unresectable or metastatic HCC who have not received prior systemic therapy.1<\/sup> In the trial, Opdivo <\/i>plus Yervoy <\/i>demonstrated statistically significant overall survival (OS) and overall response rate (ORR) vs the comparator arm.1<\/sup> It is the only trial supporting an FDA approval to show superior results against this comparator arm.1<\/sup>\n<\/p>\n

<\/a>
<\/a><\/p>\n

\n\u201cThe CheckMate-9DW approval is an important advancement for patients, considering the incidence of liver cancer has tripled in the last four decades, yet prognosis for HCC patients remains poor,\u201d said Aiwu Ruth He, MD, PhD, a CheckMate-9DW study investigator while at MedStar Georgetown University Hospital.3,4<\/sup> \u201cThe availability of a new first-line treatment option that demonstrated a deep response can offer adults with this form of liver cancer long-term overall survival and may help address an unmet need.1,5,6<\/sup> Given the strength of evidence from the trial, especially considering the selection and performance of a strong comparator arm, I believe that Opdivo <\/i>plus Yervoy <\/i>has the potential to become a standard of care for the first-line treatment of patients with unresectable or metastatic HCC.\u201d1<\/sup>\n<\/p>\n

\nIn the CheckMate-9DW trial, in which 85% of patients in the comparator arm were treated with lenvatinib and 15% were treated with sorafenib, mOS with Opdivo<\/i> plus Yervoy<\/i> (n=335) was 23.7 months (95% CI: 18.8-29.4) vs. 20.6 months (95% CI: 17.5-22.5) with lenvatinib or sorafenib (n=333; HR=0.79; 95% CI: 0.65-0.96 P<\/i>=0.0180), reducing the risk of death by 21%.1<\/sup> Opdivo<\/i> plus Yervoy<\/i> showed an OS rate of 38% at three years vs. 24% with lenvatinib or sorafenib monotherapy.1<\/sup> The trial also showed a deeper response with Opdivo <\/i>plus Yervoy, <\/i>demonstrating an ORR of 36.1% (95% CI: 31-41.5) compared to 13.2% (95% CI: 9.8-17.3; P<\/i><0.0001) of patients treated with lenvatinib or sorafenib (complete response 6.9% vs 1.8%; partial response 29.3% vs 11.4%).1<\/sup> Longer responses were seen with Opdivo <\/i>plus Yervoy <\/i>with a median duration of response (mDOR) of 30.4 months (95% CI: 21.2-NR) and 12.9 months (95% CI: 10.2-31.2) with lenvatinib or sorafenib.1<\/sup> DOR is not included in the statistical hierarchical testing and therefore is not a powered endpoint.1<\/sup> The safety profile with Opdivo<\/i> plus Yervoy<\/i> is well-established and there were no new safety signals identified.5<\/sup>\n<\/p>\n

\nOpdivo <\/i>plus Yervoy<\/i> is associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo<\/i> is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1 <\/sup>Please see the Important Safety Information section below.\n<\/p>\n

\n\u201cBringing Opdivo<\/i> plus Yervoy<\/i> to patients with HCC in the first-line setting is a testament to our ongoing commitment to research and delivering important progress for people living with cancer,\u201d said Wendy Short Bartie, senior vice president of Oncology Commercialization at Bristol Myers Squibb. \u201cToday\u2019s approval builds on the legacy of our dual immunotherapy and the value it has brought to patients for years.1<\/sup> We are thrilled to add this indication for this important therapy \u2013 our second approval<\/a> for Opdivo <\/i>plus Yervoy <\/i>in the gastrointestinal space this week alone \u2013 and look forward to providing a new first-line treatment option to patients in need.\u201d1<\/sup>\n<\/p>\n

\nThe combination of Opdivo <\/i>plus Yervoy <\/i>was previously granted accelerated approval by the U.S. FDA in 2020 based on results from the Phase 1\/2 CheckMate-040 trial and has been an established second-line treatment for patients with advanced HCC who were previously treated with sorafenib.1<\/sup> Today\u2019s FDA decision converts this existing indication to full approval and expands the indication into the first-line setting based on the results from the CheckMate-9DW trial.1<\/sup>\n<\/p>\n

\nAbout CheckMate-9DW
\n
<\/span><\/b>CheckMate-9DW is a Phase 3 randomized, open-label trial evaluating the combination of Opdivo<\/i>\u00ae<\/sup> (nivolumab) plus Yervoy<\/i>\u00ae<\/sup> (ipilimumab) compared to investigator\u2019s choice of lenvatinib or sorafenib monotherapy in patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.7<\/sup> In the trial, 668 patients were randomized to receive Opdivo<\/i> plus Yervoy<\/i> IV infusion (Opdivo<\/i> 1mg\/kg with Yervoy<\/i> 3mg\/kg every three weeks for up to four doses, followed by Opdivo<\/i> monotherapy 480mg every four weeks until disease progression, unacceptable toxicity or for a maximum duration of two years), or single agent lenvatinib (8mg orally daily, if body weight <60kg, or 12mg orally daily, if body weight \u226560kg) or sorafenib (400mg orally twice daily) in the control arm.1,5<\/sup> The primary endpoint of the trial is overall survival and key secondary endpoints include objective response rate and time to symptom deterioration.1<\/sup> The study was not designed to independently compare Opdivo<\/i> plus Yervoy<\/i> vs. lenvatinib or Opdivo<\/i> plus Yervoy<\/i> vs. sorafenib.1<\/sup>\n<\/p>\n

\nSelect Safety Profile from CheckMate-9DW
\n
<\/span><\/b>The safety analysis in CheckMate-9DW included 657 patients, of whom 332 received Opdivo<\/i> plus Yervoy.<\/i>1<\/sup> Serious adverse reactions occurred in 53% of patients treated with Opdivo<\/i> plus Yervoy<\/i>.1<\/sup> The most frequent non liver-related serious adverse reactions reported in \u22652% of patients who received Opdivo<\/i> with Yervoy<\/i> were diarrhea\/colitis (4.5%), gastrointestinal hemorrhage (3%), and rash (2.4%). Liver-related serious adverse reactions occurred in 17% of patients treated with Opdivo<\/i> in combination with Yervoy<\/i>, including Grade 3-4 events in 16% of patients. The most frequently reported all grade liver-related serious adverse reactions occurring in \u22651% of patients who received Opdivo<\/i> in combination with Yervoy<\/i> were immune-mediated hepatitis (3%), increased AST\/ALT (3%), hepatic failure (2.4%), ascites (2.4%), and hepatotoxicity (1.2%).1<\/sup> The most common adverse reactions reported in >20% of patients treated with Opdivo<\/i> plus Yervoy<\/i> were rash, pruritus, fatigue, and diarrhea. Fatal adverse reactions occurred in 12 (3.6%) patients who received Opdivo<\/i> plus Yervoy<\/i>; these included 4 (1.2%) patients who died due to immune-mediated or autoimmune hepatitis and 4 (1.2%) patients who died of hepatic failure.1<\/sup> Permanent discontinuation due to an adverse reaction occurred in 27% of patients treated with Opdivo<\/i> in combination with Yervoy<\/i>. Adverse reactions leading to permanent discontinuation in >1% of patients included immune-mediated hepatitis (1.8%), diarrhea\/colitis (1.8%), and hepatic failure (1.2%).1<\/sup>\n<\/p>\n

\nAbout Hepatocellular Carcinoma
\n
<\/span><\/b>Hepatocellular carcinoma (HCC) is a type of primary liver cancer and is the most common form of liver cancer in adults.2<\/sup> Liver cancer is the sixth leading cause of cancer deaths in the United States.8<\/sup> HCC is often diagnosed at an advanced stage and is usually associated with poor prognosis with limited effective treatment options.5,9,10<\/sup> About 42,240 people in the United Stated will be diagnosed and about 30,090 people will die of liver cancer in 2025.3<\/sup> The incidence rates of liver cancer have tripled in the U.S. since 1980 and deaths have doubled since then.3<\/sup> HCC typically develops in patients with hepatitis virus infection or cirrhosis.11 <\/sup>While most cases of HCC are caused by hepatitis B virus or hepatitis C virus infections, metabolic syndrome and metabolic dysfunction-associated steatohepatitis are rising in prevalence and expected to contribute to increased rates of HCC.11<\/sup>\n<\/p>\n

\nINDICATIONS<\/b>\n<\/p>\n

\nOPDIVO\u00ae<\/sup> (nivolumab), in combination with YERVOY\u00ae<\/sup> (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).\n<\/p>\n

\nOPDIVO\u00ae<\/sup> (nivolumab), in combination with YERVOY\u00ae<\/sup> (ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.\n<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/span><\/b>\n<\/p>\n

\nSevere and Fatal Immune-Mediated Adverse Reactions<\/b>\n<\/p>\n

\nImmune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.\n<\/p>\n

\nImmune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO or YERVOY and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.\n<\/p>\n

\nWithhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO and YERVOY or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg\/kg\/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.\n<\/p>\n

\nImmune-Mediated Pneumonitis<\/span>\n<\/p>\n

\nOPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31\/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31\/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%).\n<\/p>\n

\nImmune-Mediated Colitis<\/span>\n<\/p>\n

\nOPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection\/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, immune-mediated colitis occurred in 25% (115\/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%).\n<\/p>\n

\nImmune-Mediated Hepatitis and Hepatotoxicity<\/span>\n<\/p>\n

\nOPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70\/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%).\n<\/p>\n

\nImmune-Mediated Endocrinopathies<\/span>\n<\/p>\n

\nOPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.\n<\/p>\n

\nIn patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, adrenal insufficiency occurred in 8% (35\/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%).\n<\/p>\n

\nIn patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, hypophysitis occurred in 9% (42\/456), including Grade 3 (2.4%) and Grade 2 (6%).\n<\/p>\n

\nIn patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, hyperthyroidism occurred in 9% (42\/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%).\n<\/p>\n

\nIn patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, hypothyroidism occurred in 20% (91\/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%).\n<\/p>\n

\nImmune-Mediated Nephritis with Renal Dysfunction<\/span>\n<\/p>\n

\nOPDIVO and YERVOY can cause immune-mediated nephritis.\n<\/p>\n

\nImmune-Mediated Dermatologic Adverse Reactions<\/span>\n<\/p>\n

\nOPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1\/PD-L1 blocking antibodies. Topical emollients and\/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.\n<\/p>\n

\nYERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and\/or topical corticosteroids may be adequate to treat mild to moderate non-bullous\/exfoliative rashes.\n<\/p>\n

\nWithhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).\n<\/p>\n

\nIn patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, immune-mediated rash occurred in 28% (127\/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%).\n<\/p>\n

\nOther Immune-Mediated Adverse Reactions<\/span>\n<\/p>\n

\nThe following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1\/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac\/vascular: <\/i>myocarditis, pericarditis, vasculitis; nervous system: <\/i>meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome\/myasthenia gravis (including exacerbation), Guillain-Barr\u00e9 syndrome, nerve paresis, autoimmune neuropathy; ocular: <\/i>uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: <\/i>pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: <\/i>myositis\/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: <\/i>hypoparathyroidism; other (hematologic\/immune): <\/i>hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.\n<\/p>\n

\nIn addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: <\/i>autoimmune neuropathy (2%), myasthenic syndrome\/myasthenia gravis, motor dysfunction; cardiovascular: <\/i>angiopathy, temporal arteritis; ocular: <\/i>blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: <\/i>pancreatitis (1.3%); other (hematologic\/immune): <\/i>conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.\n<\/p>\n

\nSome ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada\u2013like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.\n<\/p>\n

\nInfusion-Related Reactions<\/b>\n<\/p>\n

\nOPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In HCC patients receiving OPDIVO 1 mg\/kg with YERVOY 3 mg\/kg every 3 weeks, infusion-related reactions occurred in 8% (4\/49) of patients.\n<\/p>\n

\nComplications of Allogeneic Hematopoietic Stem Cell Transplantation<\/b>\n<\/p>\n

\nFatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.\n<\/p>\n

\nFollow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO or YERVOY and YERVOY prior to or after an allogeneic HSCT.\n<\/p>\n

\nEmbryo-Fetal Toxicity<\/b>\n<\/p>\n

\nBased on its mechanism of action and findings from animal studies, OPDIVO or YERVOY and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.\n<\/p>\n

\nIncreased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone<\/b>\n<\/p>\n

\nIn randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.\n<\/p>\n

\nLactation<\/b>\n<\/p>\n

\nThere are no data on the presence of OPDIVO and YERVOY or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.\n<\/p>\n

\nSerious Adverse Reactions<\/b>\n<\/p>\n

\nIn CheckMate-9DW, serious adverse reactions occurred in 53% of patients receiving OPDIVO with YERVOY (n=332). The most frequent non liver-related serious adverse reactions reported in \u22652% of patients who received OPDIVO with YERVOY were diarrhea\/colitis (4.5%), gastrointestinal hemorrhage (3%), and rash (2.4%). Liver-related serious adverse reactions occurred in 17% of patients receiving OPDIVO with YERVOY, including Grade 3-4 events in 16% or patients. The most frequently reported all grade liver-related serious adverse reactions occurring in \u22651% of patients who received OPDIVO with YERVOY were immune-mediated hepatitis (3%), increased AST\/ALT (3%), hepatic failure (2.4%), ascites (2.4%), and hepatoxicity (1.2%). Fatal adverse reactions occurred in 12 (3.6%) patients who received OPDIVO with YERVOY; these included 4 (1.2%) patients who died due to immune-mediated or autoimmune hepatitis and 4 (1.2%) patients who died of hepatic failure. In CheckMate-40, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in \u22654% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis.\n<\/p>\n

\nCommon Adverse Reactions<\/b>\n<\/p>\n

\nIn CheckMate-9DW, the most common adverse reactions (>20%) in patients receiving OPDIVO with YERVOY (n=332) were rash (36%), pruritus (34%), fatigue (33%), and diarrhea (25%). In CheckMate-040, the most common adverse reactions (\u226520%) in patients receiving OPDIVO with YERVOY (n=49) were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%).\n<\/p>\n

\nPlease see U.S. Full Prescribing Information for OPDIVO<\/a> and YERVOY<\/a>.<\/b>\n<\/p>\n

\nClinical Trials and Patient Populations<\/b>\n<\/p>\n

\nCheckMate-9DW \u2013 hepatocellular carcinoma, in combination with YERVOY; CheckMate-040 \u2013 hepatocellular carcinoma, in combination with YERVOY, after prior treatment with sorafenib.\n<\/p>\n

\nBristol Myers Squibb: Creating a Better Future for People with Cancer
\n
<\/span><\/b>Bristol Myers Squibb is inspired by a single vision \u2014 transforming patients\u2019 lives through science. The goal of the company\u2019s 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.<\/p>\n

Contacts<\/b> <\/p>\n

\nBristol Myers Squibb<\/b>\n<\/p>\n

\nMedia Inquiries:<\/b>
media@bms.com<\/a>\n<\/p>\n

\nInvestors:<\/b>
investor.relations@bms.com<\/a>\n<\/p>\n

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Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator\u2019s choice of lenvatinib or sorafenib1 In the trial, 38% of patients were still alive at 3 years with this dual immunotherapy vs. 24% with the comparator arm1 PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61080","6":"format-standard","7":"category-industry"},"yoast_head":"\nU.S. Food and Drug Administration Approves Opdivo\u00ae (nivolumab) plus Yervoy\u00ae (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/u-s-food-and-drug-administration-approves-opdivo-nivolumab-plus-yervoy-ipilimumab-as-a-first-line-treatment-for-unresectable-or-metastatic-hepatocellular-carcinoma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"U.S. Food and Drug Administration Approves Opdivo\u00ae (nivolumab) plus Yervoy\u00ae (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator\u2019s choice of lenvatinib or sorafenib1 In the trial, 38% of patients were still alive at 3 years with this dual immunotherapy vs. 24% with the comparator arm1 PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) ... 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