The supplemental new drug application is based on a planned interim analysis from a phase III study of patients with relapsed or refractory multiple myeloma who had received at least one prior line of therapy, and who were randomized to receive the Doxil plus Velcade combination or Velcade alone.
Among the patients receiving the Doxil plus Velcade combination therapy the median time to disease progression was 9.3 months compared to 6.5 months for patients randomized to receive Velcade alone.
The overall survival analysis showed a trend favoring the combination therapy group, but the results were not mature and had not reached statistical significance at the time of the interim analysis.
There were 43% complete or partial responses in the Velcade monotherapy group and 48% in the combination group. The difference in response rates was not statistically significant.