Cancer vaccine did not meet PIII primary endpoint

ImClone Systems and Merck KGaA have admitted that the international, randomised Phase III clinical trial of the Companies' IMC-BEC2 cancer vaccine did not meet its primary endpoint of survival.

IMC-BEC2 is an investigational anti-idiotypic monoclonal antibody that mimics GD3, a ganglioside expressed on the cell membrane of most small cell lung cancer (SCLC) tumours. The study was conducted in collaboration with the cooperative group European Organisation for Research and Treatment of Cancer (EORTC).

The clinical trial was designed to assess the survival benefit of vaccination with IMC-BEC2 and the immune stimulant BCG over a two-year period. Patients in the trial were randomised into either the treatment arm, receiving IMC-BEC2/BCG vaccination, or into the observation arm.

'We are disappointed, but appreciate that there has been limited success with cancer vaccines in the recent past,' stated Daniel Lynch, chief executive officer of ImClone Systems. 'The conduct of clinical trials to further the treatment of cancer, regardless of their outcome, takes a tremendous commitment from the oncology community and from the courageous patients who participate. ImClone Systems remains steadfast to this commitment.'

'We would especially like to thank the co-operative study groups and the patients who participated in the trial for their commitment,' added Dr Bernhard Ehmer, vice president business area oncology, Merck KGaA. The Companies intend to meet in the near-term to discuss the ongoing viability of the IMC-BEC2 development program