Cell Therapeutics’s Phase III lymphoma trial meets primary endpoint

The Extend clinical trial is a Phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin’s lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was designed to examine the complete remission (CR) or unconfirmed complete remission (uCR) rate, overall survival and progression-free survival.

Patients randomized to treatment with pixantrone achieved a high rate of CR and uCR compared to patients treated with standard chemotherapy (14/70 (200%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients, the company said.

According to the company, pixantrone treatment also significantly increased the overall response rate (CR/uCR+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). CR/uCR and objective disease response rate (ORR) were determined by an independent assessment panel that was blinded to the treatment assignments.

The company intends to further evaluate additional details of the study and will provide complete safety and progression-free survival information comparing treatment assignments which is currently being assembled for analysis. Cell Therapeutics plans to request a pre-NDA meeting with the FDA and expects to begin submission of a rolling new drug application (NDA) to the FDA in early 2009.

James Bianco, CEO of Cell Therapeutics, said: “These data are consistent with the extensive experience with pixantrone in our Phase I and Phase II studies and demonstrate the ability to offer patients with advanced, relapsed non-Hodgkin’s lymphoma the potential to obtain a clinically meaningful response like a complete remission, despite having failed multiple other courses of chemotherapy or immuno-chemotherapy.”