Serono has discontinued its two phase 3 clinical trial programmes- onercept (recombinant tumour necrosis factor binding protein) in moderate-to-severe psoriasis and Canvaxin in Stage IV melanoma, licensed from CancerVax. The decision to discontinue these clinical trials is based on the recommendations of two separate independent Data and Safety Monitoring Boards (DSMBs).
In 2004, Serono initiated three phase 3 clinical trials in moderate-to-severe psoriasis. Investigators have recently reported two patients diagnosed with sepsis, one of whom subsequently died. Sepsis is a recognized potential risk for patients treated with anti-tumour necrosis factor (TNF) therapies. Serono convened a meeting of the independent DSMB to evaluate the available blinded efficacy data at 12 weeks for the two placebo-controlled pivotal trials and data from the first 12 weeks of the open-label trial. It was determined based on these aggregate data that the efficacy response observed for onercept was less than that observed in the earlier phase 2 trial, and with other available treatments. As a consequence of its unfavourable risk-benefit profile, the DSMB recommended to discontinue the clinical development of onercept in moderate-to-severe psoriasis, the company said in a release.
The DSMB for Canvaxin which recently completed its planned, second interim analysis of the data in Stage IV melanoma, recommended its discontinuation as the data are unlikely to provide significant evidence of a survival benefit for Canvaxin -treated patients with Stage IV melanoma versus those receiving placebo.
With regard to the currently on-going phase 3 clinical trial of Canvaxin in Stage III melanoma, the DSMB confirmed that this trial should continue. The third interim analysis of the data is expected in the third quarter of 2005. The final analysis of data from this clinical trial will take place after the required number of clinical events will have occurred, which is currently estimated to be around mid-2006, the release added.