Velcade phase II data for non-Hodgkinís and Mantle Cell lymphoma positive

Millennium Pharmaceuticals had revealed positive data from two phase II clinical trials evaluating Velcade (bortezomib) in newly diagnosed non-Hodgkin's lymphoma (NHL) patients.

The data showed that the addition of Velcade to current standards of care produced high complete response (CR) rates in patients with newly diagnosed B-cell lymphoma (BCL) and mantle cell lymphoma (MCL).

For BCL, the phase II study evaluated rituximab and cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) and Velcade in newly diagnosed BCL patients.

Professor Nicolas Mounier of Hopital Saint Louis, who led the study said: "B-cell lymphoma is the most prevalent form of NHL, which affects approximately one million patients worldwide. Although current therapies are effective for some, a number of patients still do not achieve adequate response.

The study shows that the addition of Velcade to R-CHOP, the current standard of care, improved the complete response rate and overall survival compared to historical data. These data warrant moving forward in a randomised trial to show more definitively the additive benefit of Velcade."

Results from the BCL study:

• Overall survival rate was 100 per cent after a median follow-up of 12 months
• Complete response and unconfirmed complete response rate was 83 per cent, a superior result compared with the historical response for R-CHOP given for six cycles, without Velcade, which ranged from 55 per cent to 75 per cent
• Grade Three and Four toxicities included neurological toxicities, thrombocytopenia, leucopenia and infection.

Mantle Cell Lymphoma study:
The phase II pilot study evaluated Velcade, rituximab, cyclophosphamide, vincristine, doxorubicin, and dexamethasone as initial therapy with rituximab consolidation and maintenance in newly diagnosed MCL patients.

Assistant professor Brad Kahl of the University of Wisconsin said of the MCL study: "Mantle cell lymphoma remains one of the most challenging forms of lymphoma to treat. The data presented today suggest that Velcade in combination with a current standard of care may improve the complete response rates, providing new hope for newly diagnosed mantle cell lymphoma patients As a result of these encouraging outcomes, the Eastern Cooperative Oncology Group has initiated a larger study to further evaluate the role of this Velcade-based therapy in these difficult-to-treat patients."

Results from the MCL trial:

• Overall response rate was 88 per cent with 82 per cent of patients achieving a CR/CRu
• After 12 months follow-up, median OS and progression-free survival had not yet been reached
• Grade Three and Four toxicities included peripheral neuropathy, thrombocytopoenia and neutropoenia

The manufacturer of Velcade, Janssen-Cilag, has offered to refund the UK government its money should the treatment fail in patients with bone cancer.

At the beginning of 2007, the National Institute for Health and Clinical Excellence (NICE) rejected a recommendation to allow national NHS reimbursement of Velcade.

As a result, NICE has reversed its decision and has recommended the drug be made available on the NHS for multiple myeloma patients in England and Wales who respond to the treatment.

NICE reported that "all suitable patients" will have access to the treatment, and the NHS will fund the drug for those patients who display a full or partial response. Around 60 to 70 per cent of patients are expected to fall into this response category.