ImClone reports overall survival results from Phase III lung cancer trial

These results pertaining to overall survival, a secondary endpoint, are an update to the previously reported results for progression-free survival (PFS), the study’s primary endpoint, which were announced in June 2007. The study did not meet its primary endpoint of PFS, as assessed by an independent radiology review committee.

In this recently completed analysis of BMS-099, median overall survival in patients receiving Erbitux in combination with a taxane and carboplatin was 9.7 months, compared to 8.4 months with chemotherapy alone, with a hazard ratio of 0.89 (95% CI = 0.75-1.05), p=0.17.

The results from this overall survival analysis did not reach statistical significance. BMS-099, a 676-patient study, was not powered to detect an improvement in overall survival with the same degree of statistical precision as was the larger 1,125-patient pivotal Flex multinational Phase III study conducted by Merck KGaA, Darmstadt, Germany. Nonetheless, the BMS-099 survival results support those of Flex, of which overall survival was the primary endpoint.

Eric Rowinsky, chief medical officer and executive vice president of ImClone Systems, said: “With less than one in five advanced-stage non-small cell lung cancer patients currently receiving biologic-based combination therapy in the first-line setting, ImClone is committed to providing new treatment options to address this unmet medical need.”