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news.Takeda Pharmaceutical has informed BioNumerik Pharmaceuticals that it is considering terminating their alliance over Tavocept after the drug candidate failed to meet the primary endpoints of two phase III trials in cancer patients.
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Tavocept was originated and developed by BioNumerik. The initial development focus for the drug candidate has been as an investigational new drug to prevent or mitigate the peripheral nerve damage, or neuropathy, that is known to be associated with certain commonly used classes of chemotherapy drugs, such as taxane and platinum agents.
Data was recently unblinded by BioNumerik from two placebo controlled Tavocept phase III clinical trials consisting of a trial of weekly administration of paclitaxel to patients with metastatic breast cancer, and a trial involving administration of paclitaxel and cisplatin every three weeks to patients with non-small cell lung cancer. Both of these trials were aimed at evaluating Tavocept’s potential for a neuropathy-related treatment indication.
Based on review and analysis of the results, the trials did not meet their primary endpoints and were inconclusive in terms of demonstrating a statistically significant effect of Tavocept in reducing the incidence of severe neuropathy caused by the administration of paclitaxel and/or cisplatin.
In addition, neither of the trials demonstrated a statistically significant finding in terms of objective tumor response rate or tumor protection.
Subgroup analysis of the breast cancer trial did reveal a notable finding in favor of Tavocept in the reduction of patient-reported severe neuropathy for patients enrolled only from US sites. However, only about 8% of the total number of patients treated in this trial were treated at US clinical sites.
Based on the findings, Takeda has notified BioNumerik that, given the additional time necessary to conduct additional clinical testing for a Tavocept neuropathy indication, one possible alternative is termination of the existing Tavocept license and development alliance agreement between the two companies.
Takeda and BioNumerik said that they are continuing to discuss the data from the trials, as well as considerations regarding the alliance agreement and the future development of Tavocept.