Barclays - Expect (ASH) to be positive for CELG as they demonstrate benefit in the use of Revlimid as maintenance
Barclays Capital Inc Equity Research 2 December 2013 U.S. Biotechnology ASH Conference Preview
The American Society of Hematology (ASH) conference will be held on December 7-10 in New Orleans. We have provided a brief preview of what we would focus on at the conference as well as a schedule with key sessions.
CELG focus will be on Revlimid maintenance therapy: There are four main presentations for Revlimid at ASH: MM-020, MM-015, IFM 2005-02, and a metaanalysis of Revlimid as maintenance therapy. Overall, we expect these results to be positive for CELG as they demonstrate benefit in the use of Revlimid as maintenance therapy. Based on the abstracts, Revlimid was able to show an early survival trend at 37 month follow-up in MM-020 Revlimid/dexamethasone (Rd) until disease progression vs. melphalan/prednisone/Thalomid (MPT)). MM-015 was able to show an improvement in progression-free survival but no separation in overall survival. The meta-analysis of four phase III trials evaluating Revlimid as maintenance therapy showed significant improvement in PFS and modest improvement in overall survival. The IFM 2005-02 abstract stirred up concerns as median PFS2 was shorter in the Revlimid arm (10 months) than placebo (18 months). However, this is a result of a difference in calculation method and a reverse cross-over as Revlimid patients were stopped early and given placebo while placebo patients received active drugs following progression.
Sunday, December 8, 2013
2:55pm Hall F -- Initial Phase 3 Results Of The First Trial (MM-020/IFM 07 01) In Newly Diagnosed MM Patients Ineligible For Stem Cell Transplantation CELG
6:30-8:30pm Hall G-Phase II Randomized Study of Lenalidomide or Lenalidomide and Rituximab as Maintenance Therapy Following Standard Chemotherapy For Patients With Intermediate-High/High Risk Diffuse Large B-C CELG
6:30-8:30pm Hall G Prognostic Factors Affecting Progression Free Survival For Multiple Myeloma Patients Receiving Lenalidomide Maintenance After Autologous Transplantation. Follow-Up Analysis Of The IFM 2005-02 Trial CELG
6:30-8:30pm Hall G Efficacy and Safety of Pomalidomide Plus Low-Dose Dexamethasone in Advanced Multiple Myeloma: Results of Randomized Phase 2 and 3 Trials (MM-002/MM-003) CELG
8:00-9:30pm CELG investor event CELG
Monday, December 9, 2013
PFS2 In Elderly Patients With Newly Diagnosed Multiple Myeloma (NDMM): Results From The MM-015 Study CELG
11:15am 393-394 Lenalidomide Maintenance After Stem-Cell Transplantation For Multiple Myeloma: Follow-Up Analysis Of The IFM 2005-02 Trial
CELG 11:30am 393-394 Lenalidomide Maintenance Therapy In Multiple Myeloma: A Meta-Analysis Of Randomized Trials CELG