The trial observations included an approximate 40% reduction in mortality for adenocarcinoma patients receiving Tavocept. The percentage of adenocarcinoma patients in the Tavocept group who were alive after 12 months (one-year survival) was 58% compared to 37% for adenocarcinoma patients in the chemotherapy only group.
The median survival time for all non-small cell lung cancer (NSCLC) patients in the trial showed an increase of approximately one month for patients receiving Tavocept. This is the second Tavocept clinical trial where this pattern of survival increase has been observed.
The randomized Phase II clinical trial was performed at multiple sites in the US and involved 151 patients with advanced NSCLC who received the chemotherapy drugs docetaxel and cisplatin every two weeks. Approximately half of the patients received Tavocept along with chemotherapy, while the other half received chemotherapy alone.
Additional observations from the US Tavocept trial included a lower level of treatment discontinuation due to adverse events for the Tavocept group as well as a lower frequency of serious (grade 3 and 4) treatment related adverse events. A substantial reduction in chemotherapy-induced renal toxicity and nausea was also observed in the Tavocept group.
According to the company, the US Tavocept trial observations occurred in a patient population that was predominantly non-Asian, compared to the Japan Tavocept trial where the patient population was entirely Asian. This indicates that the potential survival increase observed for adenocarcinoma patients receiving Tavocept appears to occur across different ethnic groups.