VERTICAL Phase II trial results for NHL released

Dec 9 2009

The Takeda Oncology Company today reported data from a clinical trial evaluating a VELCADE based combination for patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL). The VERTICAL Phase II trial evaluates a novel three-drug combination of VELCADE, rituximab and bendamustine (VRB), which reported an 86 percent overall response rate (ORR) and 53 percent complete response (CR) rate in patients with relapsed or refractory follicular lymphoma (FL). These data were presented at the 51st Annual Meeting of the American Society of Hematology (ASH), held December 5-8, 2009 in New Orleans, Louisiana.

“We are excited that improved response rates, including a higher CR rate, were seen with VRB compared with last prior therapy,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “These encouraging findings from the VERTICAL study complement our continued research of VELCADE in non-Hodgkin’s lymphoma, including two ongoing international Phase III registration trials.”

Bortezomib, Bendamustine, and Rituximab in Patients with Relapsed or Refractory Follicular Lymphoma: Encouraging Activity in the Phase 2 VERTICAL Study (Abstract #933)

VERTICAL is an open-label, single-arm, multi-center study to determine whether VRB provides benefit to patients with relapsed or refractory FL, as assessed by complete response (CR) rates. Of the patients enrolled, 46 percent had three or more prior therapies, and 39 percent were refractory to last prior rituximab.

Nathan Fowler, M.D., M.D. Anderson Cancer Center, presented the following data:

• ORR was 86 percent, with 53 percent of patients achieving a CR.
• The median follow-up was 6 months, and at data cut-off, the duration of responses ranged from 1 to 344 days; 17 percent of patients remain on treatment to date.
• Grade 3 peripheral neuropathy was reported in 10 percent of patients, and there were no incidents of Grade 4 peripheral neuropathy.

• There was no evidence of cumulative hematologic toxicities.
• Serious adverse events were reported in 32 percent of patients, and there was one on-study death.

The study enrolled 63 patients, and 59 were evaluable for response. All patients had received prior rituximab. Of the patients enrolled, 46 percent had three or more prior therapies, and 39 percent were refractory to last prior rituximab. Patients received five 35-day cycles of VELCADE at 1.6 mg/m² on days 1, 8, 15, and 22; bendamustine at 90 mg/m² on days 1 and 2; and rituximab at 375 mg/m² on days 1, 8, 15, 22 during cycle 1, and day 1 for cycles 2-5.

http://www.millennium.com/