Good news and bad news for CancerVax and Serono
The independent Data and Safety Monitoring Board (DSMB), which recently completed a planned, second, interim analysis of the data from a Phase III trial of CancerVax's Canvaxin, found that the data are unlikely to provide significant evidence of a survival benefit for Canvaxin-treated patients with Stage IV melanoma versus those receiving placebo. Thus, the company and Serono, CancerVax's worldwide development partner for Canvaxin, have discontinued the trial.
The independent Data and Safety Monitoring Board (DSMB), which recently completed a planned, second, interim analysis of the data from a Phase III trial of CancerVax's Canvaxin, found that the data are unlikely to provide significant evidence of a survival benefit for Canvaxin-treated patients with Stage IV melanoma versus those receiving placebo. Thus, the company and Serono, CancerVax's worldwide development partner for Canvaxin, have discontinued the trial.
However, based on a limited review of data from the Phase III clinical trial of Canvaxin in Stage III melanoma the DSMB recommended that this clinical trial continue as planned.
Thus, CancerVax and Serono intend to continue the Phase III clinical trial in Stage III melanoma, and expect that the DSMB will review the third interim analysis of data from this clinical trial in the third quarter of 2005. It is anticipated that the final analysis of data from this clinical trial will take place after the required number of clinical events have occurred, which is currently estimated to occur in mid-2006. There were no safety issues identified with either of the Phase III clinical trials of Canvaxin, and the recommendation to close the Stage IV study was not made because of any potential safety concern.
In 2004, enrollment of 1,160 patients in the Phase III clinical trial in Stage III melanoma was completed. As of the date of this announcement, a total of 496 patients out of a planned total enrollment of 670 patients were enrolled in the Phase III clinical trial in Stage IV melanoma, and further enrollment has been discontinued.
'This news is disappointing. Treatment of patients with Stage IV melanoma has proven to be very difficult and, as yet, no therapeutic agent has been shown to impact overall survival in these patients,' said David Hale, president and ceo of CancerVax. 'We would like to sincerely thank the patients and their families, and the clinicians and other healthcare professionals who participated in this clinical trial, for their strong support over the past several years.
'We remain committed to completing our Phase III clinical trial in patients with Stage III melanoma. The data from the Phase III clinical trial in Stage IV melanoma will be fully analysed, and will be presented in an appropriate scientific forum. In addition to the ongoing study in patients with Stage III melanoma, we expect to begin enrollment soon in a Phase II study to evaluate the clinical response to Canvaxin of patients with in-transit melanoma, an uncommon form of melanoma in which multiple subcutaneous or intradermal metastases are visible.'
About the DSMB
The DSMB consists of independent experts in medical and surgical oncology, statistics and medical ethics who are not participating in the clinical trials, whose primary responsibility is to monitor, on a periodic basis, the data emerging from a clinical trial and to provide recommendations to the sponsor on whether a study should be modified or discontinued.