SUMMIT, N.J.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ:CELG) today announced additional results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented at the 54th Annual American Society of Clinical Oncology Scientific Sessions (ASCO) in Chicago, Illinois on June 1-5, 2018.
This investigational study evaluated REVLIMID® (lenalidomide) plus rituximab (R2), followed by R2 maintenance, an investigational regimen, compared to the standard of care treatment of rituximab plus chemotherapy (R-chemo: R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance in patients with previously untreated follicular lymphoma. Investigators found that treatment with a chemotherapy-free R2 regimen offered numerically similar efficacy results for the primary endpoints of progression free survival (PFS) and complete response or unconfirmed complete response (CR/CRu) at 120 weeks with a different safety profile than treatment with the conventional R-chemo standard. As previously disclosed, the study did not achieve the primary endpoints of superior PFS and CR/CRu.
“These findings provide important insight into the efficacy and safety of a chemotherapy-free regimen in patients with previously untreated follicular lymphoma and represent an important step forward in understanding possible treatment options for these patients,” said Nathan Fowler, MD, Associate Professor, Department of Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center.
The co-primary efficacy endpoints of the study were CR and CRu at 120 weeks and PFS during the pre-planned analysis (final analysis of CR/CRu and interim analysis of PFS). An analysis of the findings found that 48% of patients in the R2 arm and 53% of those receiving R-chemo maintained CR/Cru 120 weeks after randomization, with a 3-year estimated interim PFS rate of 77% and 78% respectively (P=0.48, HR (95% CI) 1.10 (0.85-1.43)). Preliminary overall survival, one of the study’s secondary endpoints, showed a 3-year survival rate of 94% in both treatment arms. Other secondary endpoints included number of patients with adverse events, time to treatment failure, event-free survival, time to next anti-lymphoma treatment, time to next chemotherapy treatment, overall response rate at 120 weeks based on International Working Group (IWG) 1999 criteria, and health-related quality of life as measured by the EORTC QLQ-C30.
The majority of patients in both arms completed treatment (69% R2 and 71% R-chemo). The most common Grade 3/4 TEAEs in both arms were neutropenia (32% R2 vs. 50% R-chemo), febrile neutropenia (2% R2 vs. 7% R-chemo) and cutaneous events (7% R2 vs. 1% R-chemo). SPMs were reported in 7% R2 and 10% R-chemo patients, and Grade 5 AEs were 1% in both treatment arms.
“We believe the findings of the RELEVANCE trial add further to the understanding of the R2 regimen in patients with follicular lymphoma,” said Nadim Ahmed, President of Hematology and Oncology for Celgene. “We now look forward to the results of our AUGMENT study, which is evaluating this important regimen in previously treated patients with indolent lymphomas. These studies support our ongoing efforts to develop a portfolio of novel treatments for lymphoma.”
REVLIMID alone or in combination with rituximab is not approved for use in follicular lymphoma in any country.
RELEVANCE is the first multi-center, international, open-label, randomized phase III clinical trial of the chemotherapy-free combination immunotherapy R2 vs. R-chemo followed by rituximab maintenance in previously untreated, advanced follicular lymphoma patients. The study was conducted by Celgene in the US and Japan and by LYSARC in the rest of the world at 136 centers in 10 countries and evaluated the safety and efficacy of REVLIMID plus rituximab (R2) followed by R2 maintenance compared to the standard of care treatment of rituximab plus chemotherapy (R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance.
The trial evaluated 1030 patients with advanced follicular lymphoma who had not received prior treatment and were deemed to require treatment per Groupe d’Etude des Lymphomes Folliculaires (GELF) Criteria. Patients received treatment for 120 weeks and were randomized to receive either R2 or R-chemo treatment. The median age of the patients was 59 years.
The R2 arm received REVLIMID + Rituximab on the following dosing schedules: REVLIMID 20-mg on days 2-22 every 28 days for up to 6 cycles. Patients with a complete response after 6 cycles then received REVLIMID 10-mg on days 2-22 every 28 days for 12 cycles. Patients with a partial response after 6 cycles continued to receive REVLIMID 20 mg for 3-6 cycles until they achieved a CR/CRu, at which time they then received REVLIMID 10 mg on days 2-22 of every 28-day cycle for up to 9 or 6 cycles, respectively. Patients who remained in partial response after the additional 6 cycles received REVLIMID 10 mg for a total of 18 cycles. Rituximab 375 mg/m2 was administered on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
The R-chemo arm received ONE of the following: Rituximab – CHOP (72%), Rituximab – CVP (5%), or Rituximab – Bendamustine (23%). Seven to 8 weeks later, responding patients continued with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
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
Jun 3, 2018