Bristol-Myers Squibb Continues to Lead the Advancement of Immuno-Oncology with Broad Set of New Data at 2014 American Society of Clinical Oncology (ASCO) Annual Meeting

  • Data from company’s immuno-oncology clinical development programs to be presented in three tumor types across several lines of therapy
  • Results for the investigational PD-1 immune-checkpoint inhibitor nivolumab to be highlighted in six oral presentations, including longer-term data from some trials
  • Results for nivolumab and Yervoy® (ipilimumab) as a combination regimen in three tumor types to be presented, including melanoma and the first findings in non-small cell lung cancer and renal cell carcinoma
  • Results from Yervoy Phase 3 trial in high-risk adjuvant melanoma to be presented for first time

Category:

Monday, May 5, 2014 7:30 am EDT

Dateline:

PRINCETON, N.J.

Public Company Information:

NYSE:
BMY
"We believe that immuno-oncology has the potential to be transformational in the treatment of cancer and to have broad applicability across multiple tumor types and lines of therapy"

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3. Bristol-Myers Squibb has been at the forefront of research and discovery in the field of immuno-oncology and these data add to the growing body of research from its leading immuno-oncology pipeline, further supporting the scientific rationale for the potential of these checkpoint inhibitors as single agents or as part of a combination regimen.

“We believe that immuno-oncology has the potential to be transformational in the treatment of cancer and to have broad applicability across multiple tumor types and lines of therapy,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. “The studies that are yielding the data to be presented from our immuno-oncology pipeline—including longer-term follow up results, combination data in multiple tumor types, biomarker analyses, and findings in earlier lines of treatment—continue to demonstrate our commitment to leading scientific advances in this area. We are focused on the goal of changing survival expectations and the way that patients live with cancer.”

Melanoma

Melanoma data across lines of therapy and stages of the disease will be featured in oral presentations on June 2 at 3 p.m. CDT. Long-term data from the advanced melanoma arm of an expanded Phase 1b trial of nivolumab as a single agent in previously-treated patients will be presented (Study -003; Abstract #9002). Long-term follow up results from a Phase 1 trial studying nivolumab and Yervoy® (ipilimumab) as a concurrent combination regimen in both previously-treated and treatment-naïve patients with advanced melanoma will also be presented and featured during an ASCO press briefing at 8 a.m. CDT (Study -004; Abstract #LBA9003). This will include data from the trial on PD-L1 status.

In addition, a Phase 3 trial evaluating the investigational use of Bristol-Myers Squibb’s first approved immunotherapy, Yervoy, as an adjuvant treatment for patients with Stage 3 melanoma who are at high-risk of recurrence, will be presented for the first time and featured during the ASCO press briefing (Study -029; Abstract #LBA9008).

Lung Cancer

Bristol-Myers Squibb has a broad development program in lung cancer investigating its immunotherapies as potential treatments across histologies and lines of therapy, including evaluating the role of biomarkers.

Long-term follow up results from the NSCLC arm of Study -003 in pre-treated patients will be presented on May 31 at 1:15 p.m. CDT (Abstract #8112). Additionally, data will be featured from four arms of a Phase 1b trial evaluating nivolumab as a single agent or as part of a combination regimen, including in combination with Yervoy, in chemotherapy-naïve patients with NSCLC on June 3 at 11:30 a.m. CDT (CheckMate -012; Abstract #8024, #8023, #8022) and May 31 at 1:15 p.m. CDT (Abstract #8113). Data on PD-L1 status will also be presented.

Metastatic Renal Cell Carcinoma

Results from studies evaluating nivolumab as a single agent and as part of a regimen with other agents in mRCC will be featured in four oral presentations, including a Phase 2 dose-ranging trial in previously-treated patients (CheckMate -010; Abstract #5009) and correlative biomarker data from a Phase 1 trial in previously-treated and treatment-naïve patients (CheckMate -009; Abstract #5012) that will be presented on May 31 at 3 p.m. CDT. Additionally, results from a Phase 1 trial investigating nivolumab in a combination regimen with Yervoy, as well as in combination with sunitinib or pazopanib in previously-treated and treatment-naïve patients, will be presented on June 2 at 9:45 a.m. CDT and May 31 at 3 p.m. CDT, respectively (CheckMate -016; Abstract #4504, #5010).

Additional Data

Data from studies of other approved treatments from Bristol-Myers Squibb will also be presented at the meeting. Full session details of the 2014 Annual Meeting can be found through the ASCO iPlanner: https://iplanner.asco.org/am2014/AM2014.aspx

Immuno-oncology at Bristol-Myers Squibb

Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.

To address this unmet medical need, Bristol-Myers Squibb is leading advances in a rapidly evolving field of cancer research and treatment known as immuno-oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different and complementary pathways in the treatment of cancer.

Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer.

YERVOY® (ipilimumab) INDICATION & IMPORTANT SAFETY INFORMATION

YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

Important Safety Information

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY for any of the following:

  • Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
  • Failure to complete full treatment course within 16 weeks from administration of first dose
  • Severe or life-threatening adverse reactions, including any of the following:
    • Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (≥7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation
    • AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin >3 × the ULN
    • Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations
    • Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis
    • Severe immune-mediated reactions involving any organ system
    • Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy

Immune-mediated Enterocolitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients
  • Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis
  • Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids
  • Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms
  • Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients
  • Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)

Immune-mediated Hepatitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%
  • 13 (2.5%) additional YERVOY-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5x but ≤5x the ULN or total bilirubin elevation >1.5x but ≤3x the ULN; Grade 2)
  • Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution
  • Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids
  • Withhold YERVOY in patients with Grade 2 hepatotoxicity
  • In a dose-finding trial, Grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent YERVOY (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID)

Immune-mediated Dermatitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients
    • 1 (0.2%) patient died as a result of toxic epidermal necrolysis
    • 1 additional patient required hospitalization for severe dermatitis
  • There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis
  • Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated
  • Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY in patients with moderate to severe signs and symptoms
  • Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week

Immune-mediated Neuropathies:

  • In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported
  • Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported
  • Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes
  • Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities)

Immune-mediated Endocrinopathies:

  • In the pivotal Phase 3 study in YERVOY- treated patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients
    • All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism
    • 6 of the 9 patients were hospitalized for severe endocrinopathies
  • Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome
  • Median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY
  • Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism
    • Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated
    • Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland
  • Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:

  • In the pivotal Phase 3 study in YERVOY-treated patients, clinically significant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia
  • Across the clinical development program for YERVOY, likely immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, autoimmune thyroiditis, sarcoidosis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, and ocular myositis
  • Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions
  • Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy

Pregnancy & Nursing:

  • YERVOY is classified as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus
  • It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY

Common Adverse Reactions:

  • The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%)

Please see Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, available at www.bms.com.

YERVOY® is a registered trademark of Bristol-Myers Squibb Company.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compounds mentioned in this release will move into full product development, that the clinical trials of these compounds mentioned in this release will move into full product development, that the clinical trials of these compounds will support regulatory filings, or that the compounds will receive regulatory approvals or, if approved, that they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:

Bristol-Myers Squibb
Media
Melanie Brunner, 609-252-6338
melanie.brunner@bms.com
or
Sarah Koenig, 609-252-4145
sarah.koenig@bms.com
or
Investors
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 609-252-5020
ryan.asay@bms.com

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