Pomalyst/Imnovid results in Phase IIIb STRATUS trial for Multiple Myeloma-Celgene

Celgene Corporation has announced that results from the STRATUS� trial (MM-010), a single-arm phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory Multiple Myeloma were presented at the 56th American Society of Hematology annual meeting. Pomalidomide is marketed as Pomalyst in the United States and Imnovid in the European Union.

In the study, 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib had been enrolled at the time of the data cutoff. The primary endpoint was safety, and key secondary endpoints included pomalidomide exposure, overall response rate (ORR; partial response), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and cytogenetic analyses. Patients had a median five prior therapies. All patients received thromboprophylaxis with low-dose aspirin, low-molecular-weight heparin, or equivalent.

At a median follow-up of 6.8 months with a median four cycles received, the median progression free survival and overall survival were 4.2 months and 11.9 months, respectively. The overall response rate was 35%, with 8% of patients achieving at least a very good partial response (VGPR). The median duration of respose was 6.8 months. In patients refractory to prior lenalidomide (n=572) or lenalidomide and bortezomib (n=473), similar PFS (4.2 months and 4.1 months), OS (12 months for each), and ORR (34% and 35%) were achieved. In addition, a sub-group analysis was conducted to determine the impact of the therapy on patients with moderate renal impairment (RI). Of the 604 patients enrolled in the study, 215 had moderate RI (Creatinine clearance [CrCl] greater than 45 mL/min but less than 60 mL/min). ORR was generally similar between patient groups receiving pomalidomide plus low-dose dexamethasone (37% with moderate renal impairment vs. 33% without moderate renal impairment) despite differences in renal function. The median DOR was 6 months vs. 7.9 months, respectively. PFS was slightly extended in patients without moderate renal impairment, but did not meet statistical significance (3.7 vs. 4.6 months, p=0.1142).