Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that a retrospective analysis of MM-003, the Company’s phase III study of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide, administered either alone or in combination, were presented at the 19th European Haematology Association annual congress.

Pomalidomide is marketed as POMALYST® in the United States and IMNOVID® in the European Union.

The primary data from the MM-003 trial have been previously reported (San Miguel et al, Lancet Oncology 2013).

However, due to IDMC assessment of the final PFS analysis, more than 50% of the patients who received high-dose dexamethasone during the study crossed over to receive subsequent pomalidomide plus low-dose dexamethasone.

As such, the goal of this retrospective analysis was to estimate the difference in overall survival between the two arms of the study after adjusting for those patients who crossed over and received subsequent pomalidomide plus low-dose dexamethasone.

Utilizing a two-stage Weibull method, OS data was re-evaluated for patients in the high-dose dexamethasone arm as if crossover had not occurred.

This enabled a re-estimation of the Kaplan-Meier curve.

After adjustment for crossover, the overall survival with the combination of pomalidomide plus low-dose dexamethasone was 12.7 months, compared to 5.7 months with  high-dose dexamethasone.

In the primary analysis, the most frequent grade 3/4 adverse events (AEs) for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone were neutropenia (48% vs. 16%), anaemia (33% vs. 37%), and infections (30% vs. 24%).

Grade 3/4 deep-vein thrombosis/pulmonary embolism was infrequent (1% vs. 0%).

Only 1% of patients in each arm experienced grade 3/4 peripheral neuropathy.

Discontinuation due to AEs was 9% vs 10%.

Source: Calgene