Roche Holding AG's polatuzumab vedotin in combination with chemotherapy drug Treanda plus Rituxan met its main goal in treating a type of lymphoma in a phase 2 trial.
The trial evaluated the drug combination against Treanda, or bendamustine, plus Rituxan alone in treating relapsed or refractory diffuse large B-cell lymphoma, a cancer that starts in white blood cells.
About 40% of the patients given the investigational therapy had a complete response, or an absence of all detectable cancer, at the end of treatment compared to 15% for Treanda plus Rituxan alone.
The combination led to a predefined level of tumor shrinkage, also called an objective response rate, in 70% of patients compared to 35.2% in Treanda plus Rituxan, or rituximab, alone.
At least half of the patients given the medicine were alive after 11.8 months of treatment, versus 4.7 months for patients taking Treanda plus Rituxan alone.
The median progression-free survival, or the time until disease worsening or death, was 6.7 months for the polatuzumab vedotin arm compared to two months for the other.
The combination therapy was recently granted breakthrough therapy designation by the U.S. Food and Drug Administration and a priority medicines designation by the European Medicines Agency on the basis of the results from the study.
