Celgene laid out its case for its multiple myeloma blockbuster hopeful pomalidomide at the American Society of Hematology meeting, boasting of an improved promise of overall survival, progression-free survival and overall response rate among a group of very sick patients who had failed either Revlimid or Velcade.
Patients on a regimen of pomalidomide and low-dose dexamethasone achieved a median PFS rate of 3.6 months compared with 1.8 months in a high-dose dexamethasone arm. There was also a "highly statistically significant improvement in overall survival that crossed the upper boundary for superiority," prompting the safety monitoring committee to cross over the control arm into the pomalidomide group. And the overall response rate hit 21% compared with 3% in the control arm.
Shares of Celgene ($CELG) edged up this morning to $82.71.
The data fall in line with analysts' expectations, giving Celgene good odds at an FDA approval by the Feb. 10 PDUFA date. Bloomberg reports that four analysts give pomalidomide an average peak sales estimate of more than $1 billion a year.
Takeda's Velcade is the clear leader in the multiple myeloma market. Over the weekend, its investigators at Millennium offered positive mid-stage data on its successor to Velcade, MLN9708, which has already moved into Phase III. The sponsor said that of the 52 patients treated in Phase II, 58% demonstrated a reduction of myeloma proteins in their blood of at least 90%. Nearly a quarter of the patients taking the drug experienced a remission.
- here's the press release
- read the story from Bloomberg