Novel agent more effective than standard therapy in NHL

Preliminary results of a phase 3 study indicate that pixantrone is more effective than standard chemotherapy in patients with advanced, relapsed, aggressive non-Hodgkin lymphoma (NHL).

The phase 3 EXTEND PIX301 trial enrolled 140 NHL patients from 130 sites in 17 countries. Patients had received 2 or more prior therapies and were sensitive to anthracycline treatment.

They were randomized to receive either pixantrone or another single-agent drug currently used in this patient population and selected by a physician. The trial assessed patients’ complete remission or unconfirmed complete remission rate, overall survival, and progression-free survival.

Twenty percent of patients who received pixantrone achieved either a confirmed or unconfirmed complete remission, compared to 5.7% of patients on standard chemotherapy. Eleven percent of pixantrone patients’ remissions were confirmed, whereas none of the standard chemotherapy remissions were.

The overall response rate was 37.1% with pixantrone and 14.3% for patients on standard chemotherapy. Response rates were determined by an independent assessment panel that was blinded to treatment assignments.

Complete safety information for this study is not yet available. However, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee, and no serious concerns were raised. The most common serious toxicities (> 5%) observed in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia.

Seventy-four percent of patients enrolled in this study discontinued therapy due to disease progression or death, the majority of which were in the standard chemotherapy control arm.

This study was funded by Cell Therapeutics, Inc., the company developing pixantrone.  

Cell Therapeutics says it plans to submit complete study data for presentation at a major scientific conference. The organization also plans to request a pre-New Drug Application meeting with the FDA and expects to begin submission of a rolling New Drug Application to the FDA in early 2009.

Pixantrone is an antitumor agent that contains an aza-anthracenedione molecular structure, which differentiates it from anthracycline chemotherapy agents.

Preliminary results of a phase 3 study indicate that pixantrone is more effective than standard chemotherapy in patients with advanced, relapsed, aggressive non-Hodgkin lymphoma (NHL).

The phase 3 EXTEND PIX301 trial enrolled 140 NHL patients from 130 sites in 17 countries. Patients had received 2 or more prior therapies and were sensitive to anthracycline treatment.

They were randomized to receive either pixantrone or another single-agent drug currently used in this patient population and selected by a physician. The trial assessed patients’ complete remission or unconfirmed complete remission rate, overall survival, and progression-free survival.

Twenty percent of patients who received pixantrone achieved either a confirmed or unconfirmed complete remission, compared to 5.7% of patients on standard chemotherapy. Eleven percent of pixantrone patients’ remissions were confirmed, whereas none of the standard chemotherapy remissions were.

The overall response rate was 37.1% with pixantrone and 14.3% for patients on standard chemotherapy. Response rates were determined by an independent assessment panel that was blinded to treatment assignments.

Complete safety information for this study is not yet available. However, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee, and no serious concerns were raised. The most common serious toxicities (> 5%) observed in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia.

Seventy-four percent of patients enrolled in this study discontinued therapy due to disease progression or death, the majority of which were in the standard chemotherapy control arm.

This study was funded by Cell Therapeutics, Inc., the company developing pixantrone.  

Cell Therapeutics says it plans to submit complete study data for presentation at a major scientific conference. The organization also plans to request a pre-New Drug Application meeting with the FDA and expects to begin submission of a rolling New Drug Application to the FDA in early 2009.

Pixantrone is an antitumor agent that contains an aza-anthracenedione molecular structure, which differentiates it from anthracycline chemotherapy agents.

Preliminary results of a phase 3 study indicate that pixantrone is more effective than standard chemotherapy in patients with advanced, relapsed, aggressive non-Hodgkin lymphoma (NHL).

The phase 3 EXTEND PIX301 trial enrolled 140 NHL patients from 130 sites in 17 countries. Patients had received 2 or more prior therapies and were sensitive to anthracycline treatment.

They were randomized to receive either pixantrone or another single-agent drug currently used in this patient population and selected by a physician. The trial assessed patients’ complete remission or unconfirmed complete remission rate, overall survival, and progression-free survival.

Twenty percent of patients who received pixantrone achieved either a confirmed or unconfirmed complete remission, compared to 5.7% of patients on standard chemotherapy. Eleven percent of pixantrone patients’ remissions were confirmed, whereas none of the standard chemotherapy remissions were.

The overall response rate was 37.1% with pixantrone and 14.3% for patients on standard chemotherapy. Response rates were determined by an independent assessment panel that was blinded to treatment assignments.

Complete safety information for this study is not yet available. However, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee, and no serious concerns were raised. The most common serious toxicities (> 5%) observed in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia.

Seventy-four percent of patients enrolled in this study discontinued therapy due to disease progression or death, the majority of which were in the standard chemotherapy control arm.

This study was funded by Cell Therapeutics, Inc., the company developing pixantrone.  

Cell Therapeutics says it plans to submit complete study data for presentation at a major scientific conference. The organization also plans to request a pre-New Drug Application meeting with the FDA and expects to begin submission of a rolling New Drug Application to the FDA in early 2009.

Pixantrone is an antitumor agent that contains an aza-anthracenedione molecular structure, which differentiates it from anthracycline chemotherapy agents.