P&T COMMUNITY
 
MediMedia Managed Markets
Our
Other
Journal
Managed Care magazine
Login / Register
Join Us  Facebook  Twitter  Linked In

News Categories

 

 

 

New Clinical Data on Bortezomib (Velcade) in Multiple Myeloma

Induction therapy more effective with bortezomib than without (Apr. 7)

Results have been announced from a meta-analysis of regimens based on bortezomib (Velcade, Millennium/Takeda) compared with non–bortezomib-based regimens as induction therapy before autologous stem cell transplant (ASCT) in patients with previously untreated multiple myeloma. The new data were reported April 7 at the 14th International Myeloma Workshop in Kyoto, Japan.

The primary objective of this meta-analysis of three phase III trials was to compare the post-transplant complete response (CR) plus near-complete response (nCR) rates and progression-free survival (PFS) of bortezomib-based induction therapy (administered intravenously, twice weekly) with non–bortezomib-based induction in 1,572 previously untreated patients with multiple myeloma undergoing ASCT. Secondary endpoints included the overall response rate (ORR) and overall survival (OS).

Key results included:

  • The post-transplant CR + nCR rate for bortezomib-based regimens was 38% (n = 298) compared with 24% (n = 182) for non–bortezomib-based regimens (P < 0.0001).
  • The median PFS was 35.9 months for bortezomib-based regimens compared with 28.6 months for non–bortezomib-based regimens (P < 0.0001).
  • The post-transplant ORR was 79% (n = 615) for bortezomib-based regimens compared with 68% (n = 526) for non–bortezomib-based regimens (P < 0.0001).
  • After a median follow-up period of 37 months, the 3-year OS rates were 79.7% for bortezomib-based treatment compared with 74.7% for non–bortezomib-based treatment (hazard ratio, 0.81; P = 0.0402). The median OS had not been reached in either treatment arm.

The most common adverse events for bortezomib-based induction regimens compared with non–bortezomib-based regimens included peripheral neuropathy (34% vs. 17%, respectively), constipation (31% vs. 28%), anemia (27% vs. 29%), nausea (28% vs. 27%), thrombocytopenia (31% vs. 22%), and leukopenia (25% vs. 27%).

Velcade (bortezomib) is approved for the treatment of patients with multiple myeloma. The drug is also approved for the treatment of patients with mantle-cell lymphoma who have already received at least one prior therapy.

Source: Millennium; April 7, 2013.

More stories