Lilly stops promoting cancer drug after shock trial failure

Shares in Eli Lilly were down in early trading after the US drugmaker said its cancer drug Lartruvo failed to meet main survival goals in a late stage trial, prompting the company to stop promoting the already-marketed medicine. Lartruvo (olaratumab) is already approved in the US for advanced soft tissue sarcoma – but only from data from a smaller trial under the FDA’s accelerated approval scheme for badly-needed drugs. The company needed the data from the ANNOUNCE study to confirm that it worked in a larger group of patients. Unfortunately, the expected results did not materialize: Lilly said Lartuvo in combination with chemotherapy had missed survival endpoints in the trial using chemotherapy alone as a comparator, in patients with advanced or metastatic soft tissue sarcoma. Lilly needed the drug to improve overall survival in the full study population and in a group of patients with leiomyosarcoma for the trial to be considered a success. But initial results show there was no difference in survival between the study arms for either population. There were however no new safety signals identified and the safety profile was comparable between treatment arms.