Phase 3 Trial Update of Pixuvri for Relapsed or Refractory Aggressive non-Hodgkin Lymphoma

Cell Therapeutics announced results from its PIX301 Phase 3 clinical trial comparing Pixuvri (pixantrone) with other chemotherapeutic agents as a single-agent, salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL).

The PIX301 clinical trial was a single-agent trial of Pixuvri for patients with relapsed or refractory, aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either Pixuvri or another single-agent drug currently used for the treatment of this patient population and selected by the physician.

The primary endpoint of CR/CRu (Complete Response [CR]/Complete Response unconfirmed [CRu]) rate was 20% for Pixuvri and 5.7% for comparator (P=0.021) at end-of-treatment (EOT) and 24.3% vs. 7.1% (P=0.009) at end-of-study (EOS). ORR (Overall Response Rate) was 37.1% for Pixuvri and 14.3% for comparator (P=0.003) at EOT and 40% vs. 14.3% at EOS (P=0.001). Pixuvri patients experienced a 40% reduction in the risk of death or progression, progression free survival, over the two year study observation and follow up period compared to standard chemotherapy (medians: 5.3 months for Pixuvri vs. 2.6 months for comparator, P=0.005, HR=0.6) and a trend for reduction in the risk of death: median overall survival (10.2 months for Pixuvri vs. 7.6 months for comparator, P=0.25, HR=0.79).

Pixantrone is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents. Pixantrone also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.

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