Tavocept may raise survival, but didn’t meet endpoint

SAN ANTONIO—In a phase III trial of the investigational chemoprotective agent dimesna (Tavocept, also known as BNP7787) in patients with advanced non-small-cell lung cancer, the drug did not significantly prevent or reduce the severity of chemotherapy-induced neuropathy, its primary endpoint, BioNumerik Pharmaceuticals, Inc and ASKA Pharmaceutical Co. (Tokyo, Japan) announced in a press release.

The multicenter, double-blind, randomized placebo-controlled phase III trial, conducted by ASKA in Japan, included 182 patients who received the chemotherapy drugs paclitaxel(Drug information on paclitaxel) and cisplatin(Drug information on cisplatin) as first-line therapy for advanced NSCLC every 3 weeks.

The number of patients reporting either severe sporadic or cumulative neuropathy was approximately 50% lower in the Tavocept arm, compared with placebo, according to BioNumerik, but this did not reach statistical significance (P = .1565).

BioNumerik and ASKA believe the lack of statistical significance is likely due to the relatively small size of the trial.

A surprising observation was an increase in median survival of approximately 40 days for patients receiving Tavocept, compared with placebo. For patients with adenocarcinoma, the median survival was increased by approximately 138 days in the Tavocept patients, compared with placebo.

BioNumerik also reported a significant reduction in cisplatin-induced nephropathy and in chemotherapy-induced vomiting for Tavocept vs placebo.

“The findings of increased efficacy combined with decreased toxicity are very encouraging, but these results will require verification in other studies,” said Michael C. Perry, MD, professor of hematology and medical oncology, Nellie B. Smith Chair Emeritus, Ellis Fischel Cancer Center, University of Missouri-

Columbia, and a member of BioNumerik’s scientific advisory board.