Celgene abandons plans for new Revlimid indication after trial disappointment
- Celgene's top cancer drug Revlimid failed to improve overall survival in patients with diffuse large B-cell lymphoma (DLBCL) during a phase 3 REMARC trial, although it did increase progression-free survival in that group of patients, the company announced Monday.
- Revlimid is currently approved to treat multiple myeloma (in combination with dexamethasone), myelodysplastic syndrome and mantle cell lymphoma.
- Although Celgene plans to complete the REMARC clinical development program, which is comprised of four other Revlimid studies, the company will no longer be pursuing approval for Revlimid in DLBCL.
Last year, Revlimid generated $5.8 billion in revenue, representing 63% of Celgene's overall sales. Since its approval in 2005, Celgene has racked up approvals in first- and second-line treatment settings for various types of non-Hodgkin lymphoma (NHL), but DLBCL has been a hard nut to crack. DLBCL is the most common type of NHL, affecting roughly one-third of all NHL patients. It also has a dismal five-year survival rate.
Recently Roche got bad news when its blood cancer drug Gazyva failed to increase progression free survival in DLBCL patients. Meanwhile, CAR-T biotech Kite Pharma is pushing towards the finish line with KTE-C19, which is in development for various blood cancers. Kite's is aiming to win its first approval for DLBCL.
Celgene, in partnership with the Lymphoma Study Association (LYSA), tested Revlimid as a maintenance therapy in patients who had responded to first-line rituximab plus CHOP chemotherapy induction therapy.
And although Celgene will cease to focus on treating DLBCL, the company will not abandon the REMARC clinical program. “We are continuing to partner with LYSA to complete the analyzes of the REMARC study." said Michael Pehl, President Hematology and Oncology of Celgene. "We remain committed to finishing the four ongoing phase III trials evaluating Revlimid and are confident about its potential as a treatment option across different settings in lymphoma.”
- Celgene Statement