Celgene Corporation
Dec 11, 2012
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Data Evaluating Combination Treatments Including REVLIMID® Plus Antibody Therapies in Patients with Various Difficult-to-Treat Forms of Non-Hodgkin Lymphoma Presented at the 54th American Society of Hematology Annual Meeting

ABSTRACTS 689, 901, 3668, and 3692

BOUDRY, Switzerland--(BUSINESS WIRE)--Dec. 11, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced results from several studies evaluating combination treatment with REVLIMID® (lenalidomide) and antibody therapy in non-Hodgkin lymphoma (NHL). The data were presented at the 54th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA.

The presented data included two Phase II trials on the combination of lenalidomide with R-CHOP, a Phase I/II trial evaluating the combination of lenalidomide and ofatumumab, and a Phase II trial analyzing the combination of lenalidomide and rituximab.

First, a Phase II trial (abstract #689) evaluated lenalidomide in combination with R-CHOP (rituximab-CHOP) in patients with aggressive B-cell lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma. Treatment resulted in an overall response rate (ORR) of 98% and one-year progression-free survival (PFS) rate of 73%. Grade ≥3 hematological toxicities were thrombocytopenia (40%), neutropenia (89%), and anemia (19%). Non-hematological side effects of grade 3 or higher included febrile neutropenia (10%), pneumonia (4%), sepsis (2%), venous thrombosis (2%), fatigue (6%), and dehydration (6%).

Another Phase II trial (abstract #3668) evaluated the clinical activity of lenalidomide as maintenance therapy following R-CHOP in patients with diffuse large B-cell lymphoma who achieved a complete response to the chemotherapy regimen. At a median follow up of 24 months, patients who received maintenance lenalidomide achieved a median two-year PFS rate of 92%, compared with 83% for patients treated with lenalidomide plus rituximab as maintenance; overall survival rates were 92% and 77%, respectively. Grade ≥3 toxicities include neutropenia (25%), fatigue (15%), hypothyroidism (5%), deep-vein thrombosis (3%), and rash (3%).

A phase I/II trial (abstract #3692) evaluated lenalidomide in combination with ofatumumab in patients with relapsed/refractory B-cell NHL. Patients in this trial with follicular lymphoma demonstrated an ORR of 83% and a one-year PFS of 67%. Overall, grade 4 neutropenia occurred in 24% (9/37) of patients, and one case occurred for each of grade 4 bacteremia, grade 4 deep vein thrombosis, stroke, and acute renal failure.

Lastly, final results of a Phase II trial (abstract #901) evaluated lenalidomide plus rituximab in patients with advanced stage, untreated indolent NHL, with an ORR of 90%. In the study, the estimated three-year PFS was 78%. Grade ≥3 neutropenia occurred in 41% of patients, and thrombocytopenia in 6% of patients. The most common grade ≥3 non-hematologic toxicities included muscle pain (8%), rash (7%), and fatigue (5%), thrombosis (3%) and other pulmonary events (4%). Five patients developed neutropenic fever.

These data are from investigational studies. REVLIMID® is not approved for use in patients with non-Hodgkin lymphoma.

About REVLIMID

REVLIMID is an IMiDs® compound. REVLIMID and other IMiDs continue to be evaluated in over 300 clinical trials worldwide. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of- matter and use patents.

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.

Since 1998, Celgene continues to be a pioneer in creating environments in which patients can benefit from our disease-altering therapies safely. As a result, hundreds of thousands of patients worldwide have accessed the clinical benefits of our therapies through our performance-based risk management programs including, S.T.E.P.S.®, RevAssist® and RevMate®, which form the foundation of our commitment to patient safety.

U.S. Regulatory Information for Revlimid

REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy.

REVLIMID® (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Important Safety Information

WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. In women of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Women of childbearing potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid fetal exposure to lenalidomide, REVLIMID is only available under a restricted distribution program called “RevAssist®.”

Information about the RevAssist program is available at www.REVLIMID.com or by calling the manufacturer’s toll-free number 1-888-423-5436.

HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors. (see DOSAGE and ADMINISTRATION)

DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with MM who were treated with REVLIMID and dexamethasone therapy. Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with REVLIMID may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patient’s underlying risk factors.

CONTRAINDICATIONS:

Pregnancy Category X:

Allergic Reactions:

WARNINGS AND PRECAUTIONS:

Fetal Risk:

Reproductive Risk and Special Prescribing Requirements (RevAssist Program):

Hematologic Toxicity—Multiple Myeloma:

Deep Vein Thrombosis and Pulmonary Embolism:

Allergic Reactions:

Tumor Lysis Syndrome:

Tumor Flare Reaction:

Hepatotoxicity:

Second Primary Malignancies

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Nursing Mothers:

Geriatric Use:

Renal Impairment:

ADVERSE REACTIONS:

Multiple Myeloma

Myelodysplastic Syndromes

DOSAGE AND ADMINISTRATION:

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

About Non-Hodgkin Lymphoma

Lymphoma is the name for the group of blood cancers that start in the lymphatic system, which is part of the body’s immune system. Lymphomas generally start in the lymph nodes or lymphatic tissue in sites of the body such as the stomach or intestines. They may involve the marrow and the blood in some cases as well. Most people with lymphoma have one of the many different kinds of non-Hodgkin’s lymphoma (NHL) and there are an estimated 360,000 cases of NHL in the U.S. with more than 59,000 new cases diagnosed annually.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Source: Celgene International Sàrl

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