Revlimid lenalidomide: Additional Phase III data

Additional data from the double-blind, U.S. Phase III CALGB-100104 trial in 460 subjects showed that 5-15 mg/day Revlimid as maintenance therapy following autologous stem cell transplantation met the secondary endpoint of a significant improvement in OS at a median follow-up of 28 months vs. placebo (90% vs. 83%, p=0.018). Median time to progression was significantly higher for Revlimid-treated patients vs. placebo (48 vs. 30.9 months, p<0.0001). Median event-free survival also was significantly higher for Revlimid-treated patients (43.4 vs. 30.9 months, p<0.0001).

Celgene did report an increase in second primary malignancies in patients treated with Revlimid vs. placebo. However, the company said when the malignancies were included as events in the event-free survival analysis, the malignancies did not significantly affect OS or the time to progression. The most common grade 3/4 adverse events were neutropenia (43% for Revlimid vs. 9% for placebo), thrombocytopenia (13% vs. 4%) and infections (16% vs. 5%). Data were presented at the International Myeloma Workshop meeting in Paris. The trial was sponsored by NIH's National Cancer Institute (NCI). ...