Investigational Compound Peginterferon Lambda Achieved SVR24 Rates Comparable to Peginterferon Alfa with Fewer Flu-Like and Musculoskeletal Symptoms in Phase IIb Study in Treatment-Naïve Genotype 2 or 3 Hepatitis C Patients

  • First report of sustained virologic response (SVR) results for Lambda interferon
  • Numerically greater virologic response rates consistent at 4 weeks (RVR*), throughout treatment, and maintained through SVR24in Lambda 180 µg dose versus alfa
  • Data presented at The International Liver Congress in Barcelona

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced results from the Phase IIb EMERGE clinical trial in 118 treatment-naïve patients chronically infected with genotype 2 or 3 hepatitis C virus (HCV). In this study, the investigational compound peginterferon lambda-1a (Lambda) plus ribavirin (RBV) achieved sustained virologic response rates 24 weeks post-treatment (SVR24) that were comparable to peginterferon alfa-2a (alfa) plus ribavirin. Rates of SVR24 ranged from 60.0% to 75.9% in the Lambda/RBV arms versus 53.3% in the alfa/RBV arm (n=30). The 180 µg dose arm of Lambda/RBV achieved SVR24 in 75.9% (n=29) and was the dose selected for phase III clinical trials.

In this study, adverse events were mostly low grade and self-limited. Overall, rates of serious adverse events and adverse events were similar across treatment arms up to SVR24. There were fewer flu-like and musculoskeletal symptoms in the Lambda/RBV arms. Additionally, lower rates of anemia, neutropenia, and thrombocytopenia were observed and there were fewer interferon and ribavirin dose reductions for anemia in the Lambda/RBV arms. Two (2) cases of hyperbilirubinemia >5x the upper limit of normal (ULN) were observed in the Lambda 240 µg dose arm and zero (0) cases of hyperbilirubinemia >5x the upper limit of normal (ULN) were observed in the Lambda 180 µg, Lambda 120 µg, and alfa arms.

These EMERGE study findings in hepatitis C genotype 2 and 3 patients were presented in an oral session at the International Liver Congress (ILC), the 47th annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain.

“There is a significant unmet medical need for antiviral therapies that can benefit more hepatitis C patients with a goal of decreasing treatment-related adverse events and potentially reducing treatment duration," said Stefan Zeuzem, MD, chief of the department of medicine and professor of medicine at the Goethe University Hospital in Frankfurt, Germany. "The EMERGE study results of peginterferon lambda versus peginterferon alfa in patients infected with HCV genotype 2 or 3 demonstrate that peginterferon lambda, in combination with ribavirin, may have the potential to help address these unmet needs, and these data support further studies of this investigational Lambda interferon.”

Study Results

Viral Response

The primary endpoint of the study was the proportion of patients with complete early virologic response (cEVR). Treatment with all doses of Lambda achieved cEVR rates similar to alfa (Lambda 240 µg: 86.7%, Lambda 180 µg: 96.6%, Lambda 120 µg: 89.7%, and alfa: 86.7%). Higher rates of RVR were achieved in the Lambda arms [Lambda 240 µg: 66.7% (p<0.05), Lambda 180 µg: 75.9% (p<0.05), Lambda 120 µg: 44.8% vs. alfa: 30%]. In patients with HCV genotypes 2 and 3, treatment with all doses of Lambda achieved SVR24 rates similar to PEG-Interferon alfa [Lambda 240 µg: 60.0% (n=30), Lambda 180 µg: 75.9% (n=29), Lambda 120 µg: 65.5% (n=29), and alfa: 53.3%, (n=30)].


Overall, the rates of serious adverse events and adverse events were similar across treatment arms up to SVR24. In this study, there were some differences seen in the relative frequency of adverse events between lambda and alfa. Some of the adverse events commonly associated with interferon treatment such as flu-like symptoms (Lambda 240 µg: 23.3%; Lambda 180 µg: 20.7%; Lambda 120 µg: 17.2%; alfa: 40.0%), musculoskeletal symptoms (Lambda 240 µg: 16.7%; Lambda 180 µg: 20.7%; Lambda 120 µg: 27.6%; alfa: 63.3%), constitutional symptoms such as fatigue (Lambda 240 µg: 50.0%; Lambda 180 µg: 27.6%; Lambda 120 µg: 41.4%; alfa: 53.3%), neutropenia < 750/mm³ (Lambda 180 µg: 0.0%, n=29; alfa: 27.5%, n=30), anemia with hemoglobin < 10 g/dL or a decline of > 3.4g/dL (Lambda 180 µg: 6.9%, n=29; alfa: 44.8%, n=30), and thrombocytopenia < 100,000/mm3 (Lambda 180 µg: 0.0%, n=29; alfa: 24.1%, n=30) were less frequently seen with Lambda than with alfa. Some others such as psychiatric (Lambda 240 µg: 40.0%; Lambda 180 µg: 41.4%; Lambda 120 µg: 44.8%; alfa: 33.3%) and neurologic (Lambda 240 µg: 36.7%; Lambda 180 µg: 24.1%; Lambda 120 µg: 27.6%; alfa: 33.3%) adverse events were similar across groups.

The proportion of patients that required interferon dose reductions were: Lambda 240 µg: 13.3%; Lambda 180 µg: 6.9%; Lambda 120 µg: 6.9%; alfa: 26.7%, and the proportion of patients that required withheld and/or reduced ribavirin were: Lambda 240 µg: 23.3%; Lambda 180 µg: 6.9%; Lambda 120 µg: 24.1%; alfa: 43.3%. The proportion of patients who required ribavirin dose reductions for low hemoglobin were: Lambda 240 µg: 0.0%; Lambda 180 µg: 0.0%; Lambda 120 µg: 0.0%; alfa: 23.3%.

The proportion of patients with elevated liver enzymes [AST or ALT > 10x the upper limit of normal (ULN)] were: Lambda 240 µg: 3.3%; Lambda 180 µg: 0.0%; Lambda 120 µg: 0.0%; alfa: 0.0%. Total bilirubin was also elevated > 5.0x ULN in the highest-dose Lambda treatment arm compared with PEG-Interferon alfa (Lambda 240 µg: 6.7%; Lambda 180 µg: 0.0%; Lambda 120 µg: 0.0%; alfa: 0.0%); all resolved following interferon dose modification and/or discontinuation.

About the EMERGE Phase IIb Study

The EMERGE study is a two-part, randomized, controlled, multicenter, phase II study of peginterferon lambda-1a in treatment-naïve patients with chronic hepatitis C genotype 1, 2, 3 or 4. Part one of EMERGE was a Phase IIa study, and results were previously presented at The American Association for the Study of Liver Diseases (AASLD) 2010 Liver Meeting.

Part two of EMERGE is an ongoing, blinded Phase IIb study designed to evaluate the safety, efficacy, and pharmacokinetics of Lambda versus alfa, both in combination with ribavirin. In the study, the 526 non-cirrhotic patients were randomized into four dose groups: Lambda 240 µg, Lambda 180 µg, Lambda 120 µg, and alfa 180 µg. Of the 526 patients, 118 patients with genotype 2 or 3 chronic hepatitis C were randomized into four dose groups: Lambda 240 µg (n=30), Lambda 180 µg (n=29), Lambda 120 µg (n=29) and alfa 180 µg (n=30). The results for these 118 patients were presented today at The International Liver Congress 2012.

Phase IIb RVR and cEVR results for genotypes 1, 2, 3, and 4 were previously presented at The International Liver Congress in 2011. The study continued for 24 weeks in genotype 2 and 3 patients and will continue for 48 weeks in genotype 1 and 4 patients. The primary endpoint of the study is the proportion of patients who achieve complete early virologic response (cEVR). HCV RNA and safety were assessed through 48 weeks (24-weeks on-treatment and 24-weeks post-treatment or to SVR24).

About Bristol-Myers Squibb’s Commitment to Liver Disease

Bristol-Myers Squibb is researching a portfolio of compounds that aim to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. The Company’s hepatitis C pipeline includes a portfolio of compounds with different mechanisms of action, pursuing both biologics as well as small molecule antivirals. These compounds are being studied as part of multiple novel treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies. Peginterferon lambda-1a is the first investigational type III interferon in Phase IIb development for the treatment of hepatitis C. Native human interferon lambda proteins are generated by the immune system in response to viral infection, and signal through a different receptor than native human interferon alfa proteins. Lambda receptors are present on fewer cell types within the human body than alfa receptors. This restricted distribution of the interferon lambda receptor offers the potential for more targeted delivery of interferon therapy.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer. Although there is no vaccine to prevent hepatitis C, it is a potentially curable disease.

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, please visit or follow us on Twitter at

Bristol-Myers Squibb Forward Looking Statement

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* Rapid virologic response (RVR): undetectable viral load (HCV RNA <25 IU/mL) at week 4

† Sustained Virologic Response 24 or SVR24: undetectable viral load 24 weeks post-treatment, demonstrative of cure

Complete Early Virologic Response or cEVR: undetectable viral load at week 12

Bristol-Myers SquibbMedia:Cristi Barnett, 609-252-6028cristi.barnett@bms.comorInvestors:John Elicker,

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