BioNumerik Pharmaceuticals, Inc. ("BioNumerik") today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer. Tavocept, originated and developed by BioNumerik, is an investigational new drug with potential for oncology and non-oncology indications.
"In two independent studies of first-line use of Tavocept with chemotherapy, we observed an increase in overall survival of up to 6.7 months in patients with primary adenocarcinoma of the lung, the most common type of lung cancer worldwide," said Frederick H. Hausheer, M.D., F.A.C.P., founder, chairman & chief executive officer of BioNumerik. "If the results of the current Phase III trial prove to be consistent with prior results, Tavocept treatment could result in the largest historically observed increase in patient survival for a first-line agent for the treatment of primary adenocarcinoma of the lung."
The Phase III Tavocept trial is an international, randomized, multicenter, double-blind, placebo-controlled trial to be conducted at approximately 80 to 100 clinical sites in the United States, Russia, Ukraine, Eastern Europe and Latin America. The primary objective is to confirm whether Tavocept plus taxane and cisplatin chemotherapy significantly increases overall survival in patients with advanced primary adenocarcinoma of the lung compared to taxane and cisplatin treatment alone. Tavocept's ability to prevent or mitigate common chemotherapy-induced toxicities will be prospectively evaluated by pre-specified secondary endpoint analyses. BioNumerik estimates that patient enrollment for the trial could be completed in late 2010 to early 2011.
Two smaller randomized, multicenter trials of Tavocept, in combination with taxane and cisplatin chemotherapy, previously demonstrated large increases in overall survival and one year survival, compared to the control regimens, in patients with newly diagnosed (inoperable) stage IIIB/IV primary adenocarcinoma of the lung. These increases include a 6.7 month increase in overall survival (8.9 months in control vs. 15.6 months in Tavocept treated patients), with 60% of Tavocept treated patients vs. 36% of control treated patients alive at one year after randomization in a U.S. Phase II clinical trial, and a 4.6 month increase in overall survival (15 months in placebo vs. 19.6 months in Tavocept treated patients), with 73% of Tavocept treated patients vs. 54% of placebo treated patients alive at one year after randomization in a Japanese Phase III trial. These improved survival outcomes were accompanied by medically and statistically significant reductions in favor of Tavocept treatment in the incidence and severity of side effects commonly observed with the chemotherapy control regimens, including reductions in kidney toxicity, anemia, nausea and vomiting, and treatment discontinuation due to chemotherapy-induced neuropathy.
Meta-analysis supports survival improvements in patients with advanced non-small cell lung cancer (NSCLC):
The results of a comprehensive meta-analysis of these two previous randomized Tavocept trials were published this week by the European Journal of Clinical & Medical Oncology (EJCMO). [link to abstract] The meta-analysis examined survival outcomes for a combined total of 346 newly diagnosed randomized patients with advanced NSCLC participating in the two trials, including 211 randomized patients with primary adenocarcinoma of the lung. All patients received treatment with taxane plus cisplatin chemotherapy. Approximately half of the patients were treated with Tavocept while the other half received chemotherapy alone. The analysis demonstrated a significant overall survival benefit in favor of Tavocept treatment for the combined meta-analysis of the two trials. For the adenocarcinoma subtype, the combined analysis demonstrated a significantly>
"The results of the meta-analysis are encouraging and have important medical implications for the first-line treatment of primary adenocarcinoma of the lung," stated Robert Pirker, M.D., Medical University of Vienna, Austria, and a member of the EJCMO Editorial Board. "Confirmation of these important results in a well controlled Phase III trial would represent a major advance in the treatment of patients with advanced lung cancer."
Nicholas Thatcher, Professor in Medical Oncology at the University of Manchester and The Christie, England and EJCMO Editorial Board member said, "The potential to improve therapy in primary adenocarcinoma, the most common form of lung cancer, is an exciting possibility. The results of the meta-analysis provide important support for a large scale confirmatory study of Tavocept on patient survival and the prevention of common chemotherapy side effects."