Updated Data from Phase IIIb MAGNIFY Study of REVLIMID (lenalidomide) and Rituximab Combination (R2) Show Clinical Activity and Responses in Relapsed/Refractory Follicular and Marginal Zone Lymphoma

Interim data from the study evaluating the investigational chemotherapy-free R2 combination regimen, presented at ASCO and expanded data presented at ICML

Results showed clinical activity across indolent non-Hodgkin lymphomas, marginal zone and follicular histologies, as well as responses in poor risk patient subpopulations including early relapsing patients and patients who were refractory to multiple lines of therapy

SUMMIT, NJ, USA I June 17, 2017 I Celgene Corporation (NASDAQ: CELG) today announced results from an interim analysis of MAGNIFY, a phase IIIb, randomized, open-label, multicenter study of REVLIMID (lenalidomide) plus rituximab (R2) combination therapy in patients with relapsed or refractory marginal zone lymphoma (MZL). Results were presented at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland and expanded upon data presented earlier in the month at the American Society of Clinical Oncology (ASCO) meeting in Chicago, Ill.

The MAGNIFY study continues to evaluate the clinical activity of 12 cycles of R2 combination therapy followed by randomization to either 18 cycles of R2 maintenance or 18 cycles of rituximab monotherapy, in patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) or mantle cell lymphoma (MCL). Approximately 500 patients are planned to be enrolled in the study. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), overall response rate (ORR), complete response (CR), improvement of response (IOR), duration of response (DOR) and duration of complete response (DOCR), time to next lymphoma treatment (TTNLT), time to histological transformation (TTHT), safety and exploratory quality of life measures. Enrollment in the MAGNIFY study is ongoing.

“Interim data from the MAGNIFY study continue to show the clinical potential for the R2 combination across a broad range of lymphomas,” said Michael Pehl, President, Hematology/Oncology at Celgene. “As we await data from our late-stage programs, including the phase III AUGMENT and RELEVANCE studies, we hope that the growing volume of evidence for R2 may lead to new options for patients that offer an alternative to traditional cytotoxic chemotherapies.”

At ASCO, interim data were presented from an analysis of a subset of patients from the MAGNIFY study with relapsed or refractory FL (n=160) with early relapse (ER, n=52) and double-refractory (DR, n=50) disease. At the January 9, 2017 data cut-off, the 1-year PFS for all FL patients was 70%, with 65% for DR patients and 49% for ER patients. Additionally, evaluable FL patients (n=128) had an ORR of 66% with a CR/CRu rate of 38%. For DR patients (n=42), ORR was 45% with a CR/CRu rate of 21% and for ER patients (n=43), ORR was 47% with a CR/CRu rate of 21%. Median DOR was not met at a median follow-up of 10.2 months.

Most common grade 3 or 4 adverse events observed in the study for all FL patients, DR patients and ER patients, respectively, were neutropenia (29%, 42%, 37%), fatigue (6%, 4%, 8%), leukopenia (5%, 8%, 10%), thrombocytopenia (4%, 8%, 4%) and lymphopenia (3%, 6%, 4%).

Data being presented at ICML in a separate analysis focused on patients with MZL (n=38), including nodal MZL (n=18), splenic MZL (n=10) and mucosa-associated lymphoid tissue (MALT) lymphoma (n=10). At a median follow-up of 13.8 months from initiation of therapy with the R2 combination, evaluable patients with MZL (n=32) achieved an ORR of 66% with a CR/CRu rate of 44%. Evaluable nodal MZL patients (n=14) had an ORR of 57% with a CR/CRu rate of 57%. Evaluable splenic MZL patients (n=8) had an ORR of 63% with a CR of 25%; and evaluable MALT patients (n=10) had an ORR of 80% with a CR/CRu rate of 40%. Median duration of response was not reached for any group.

The most common grade 3 or 4 adverse events observed in patients with MZL were neutropenia (32%), thrombocytopenia (16%) and leukopenia (11%).

“The chemotherapy-free combination of lenalidomide and rituximab, with complementary mechanisms of action that are thought to enhance antibody dependent cellular cytotoxicity, continues to show encouraging activity and a tolerable safety profile in indolent lymphomas, and particularly in difficult-to-treat patient subsets,” said David J. Andorsky, M.D., co-principal investigator of the study and medical oncologist at the Rocky Mountain Cancer Centers in Boulder, CO. “These results in patients who had failed multiple therapies or relapsed early, as well as the activity in marginal zone patients merit further study in this area of indolent lymphoma.”

About MAGNIFY

MAGNIFY (NCT01996865) is a phase IIIb, multicenter, open-label study of patients with grades 1-3b or transformed FL, MZL, or MCL who received ≥1 prior therapy and had stage I-IV, measurable disease. Approximately 500 patients are planned for enrollment in 12 cycles of R2 induction, with a projected 314 patients with ≥SD after induction randomized (1:1) to two maintenance arms. Induction included oral lenalidomide 20 mg/day, days 1-21 per 28-day cycle (d1-21/28) plus intravenous rituximab 375 mg/m2, days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 3, 5, 7, 9, and 11 (28-day cycles). Patients are then randomized to maintenance lenalidomide 10 mg/day, d1-21/28, cycles 13-30, plus rituximab 375 mg/m2, day 1 of cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 (R2, Arm A), or rituximab alone (same schedule, Arm B). Patients receiving R2 maintenance after 18 cycles may continue maintenance lenalidomide monotherapy 10 mg/day, d1-21/28 (per patient and/or investigator discretion), until disease progression as tolerated. Patients will be followed for ≥5 years after the last patient initiates induction therapy.

About Follicular and Marginal Zone Lymphomas

FL is the most common indolent (slow-growing) form of NHL, accounting for approximately 22% of all B-cell Non-Hodgkin lymphoma (NHL) patients. Most patients present with advanced disease usually when lymphoma-related symptoms appear (e.g., nodal disease, B symptoms, cytopenia) and receive systemic chemoimmunotherapy. While FL patients are generally responsive to initial treatment, the disease course is characterized by recurrent relapses over time with shorter remission periods. MZL are a heterogeneous group of indolent lymphomas that account for 8% of all NHL. While often treated like FL, MZL has important differences in clinical presentation and pathogenesis. Patients with MZL have historically been grouped within studies of mixed indolent NHL histologies, and large studies are lacking to validate appropriate treatment for MZL patients.

REVLIMID was granted Orphan Drug Designation for the treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue in April 2015.

REVLIMID is not approved for combination use with rituximab for any purpose or for the treatment of follicular lymphoma or marginal zone lymphoma.

About REVLIMID®

REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)

REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)

REVLIMID® 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

REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on social media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

SOURCE: Celgene

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