RxTrials Institute Drug Pipeline Alert

BioNumerik Pharmaceuticals and Japan-based Aska Pharmaceutical have concluded a Phase III clinical trial of Tavocept in patients with advanced nonsmall cell lung cancer.

The multicenter, double-blind, randomized, placebo-controlled trial was conducted by Aska through the joint venture with BioNumerik. The trial included 182 patients who received paclitaxel and cisplatin as first-line therapy every three weeks.

The primary endpoint was to evaluate Tavocept’s potential for preventing and reducing the severity of sporadic and cumulative nerve damage, or neuropathy, experienced by patients receiving paclitaxel and cisplatin chemotherapy.

The trial results indicate that the number of patients reporting either severe sporadic or cumulative neuropathy was approximately 50 percent lower in the Tavocept arm compared with the placebo arm. While this outcome represents a strong trend in favor of Tavocept, the results are not statistically significant, perhaps due to the small size of the trial.

However, there was an observed increase in the median survival time for patients receiving Tavocept, which was approximately 40 days longer than in those taking placebo, according to BioNumerik.