Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has announced what it calls disappointing results of a study of a new cancer drug. The pharmaceutical giant says the Phase 3 study of Lartruvo, which aims to treat patients with advanced or metastatic soft tissue sarcoma, did not meet its primary endpoints.
The study involved the use of Lartruvo in combination with doxorubicin, which alone is the standard of care treatment for STS. Lilly says the study showed no difference in survival for patients involved.
Lilly says the combination of Lartruvo and doxorubicin previously showed a benefit in a 133-patient, U.S.-only, randomized Phase 2 trial, which led to an accelerated approval by the U.S. Food and Drug Administration. The company is now working with global regulators to determine the appropriate next steps for the drug.
"Lilly was surprised and disappointed that LARTRUVO did not improve survival for patients with advanced soft tissue sarcoma in this study," said Anne White, president of Lilly Oncology. "Lilly is committed to helping people who have soft tissue sarcoma and we will carefully study the detailed data in an effort to better understand the different results between the two trials."
Lilly says it is suspending promotion of Lartruvo for the time being. The company expects to incur a charge in the first quarter related to Lartruvo, which could range from $70 million to $90 million.