Baird "Would be buyers of CELG into the low 90s.Positive ASH update for Revlimid and Pomalidomide - would be buyers of CELG into the low 90s.".
Baird Positive ASH update for Revlimid and Pomalidomide - would be buyers of CELG into the low 90s....
Celgene Corporation (CELG)
Incrementally Positive ASH Update for Revlimid and Pomalidomide
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Initial reaction – incrementally positive. Two key presentations this morning at ASH for CELG.
· Nice update for Revlimid in MM-015 trial, as hoped. Recall, MM-015 compared Revlimid plus melphalan and prednisone with Revlimid maintenance (MPR-R) versus MPR or MP in newly diagnosed multiple myeloma (MM) patients. CELG presaged on Sunday that the MM-015 data would be a key update and the presentation did not disappoint. Key incremental points:
o Separation of overall survival (OS) curves appears to be emerging. We note greater separation on OS beginning to emerge with MPR-R and MPR patients from MP patients. Recall, a more clearly defined OS trend will be necessary for EU front-line application, and we think this should ultimately help support resubmission.
o Fewer relapses on MPR-R. Median first-line time to progression (TTP) was greatest for MPR-R patients at 29 months compared to 15 months and 14 months for MPR and MP, respectively. While not stat-sig, it does suggest both earlier use of Revlimid and maintenance Revlimid use contribute to fewer relapses.
o No Revlimid resistance noted when used up front. No differences across second-line TTP between MPR-R, MPR and MP patients, with median TTP of 14, 16, and 15 months, respectively. Recall, potential downstream resistance was one of the key issues CHMP raised when they released the EPAR documents relative to Revlimid’s withdrawn front-line application.
· Pomalidomide’s (pom) MM-003 does not disappoint. In this Phase III randomized trial in RRMM patients who have failed both Revlimid and Velcade met the primary endpoint improved PFS versus high-dose dexamethasone (dex) with a median PFS of 3.6 months Pom+low-dose dex versus 1.8 months high-dose dex. OS benefit also very impressive. Pom + low-dose dex median OS not reached but curve out to 16 months. High-dose dex 7.8 months. H.R. 0.53, p