Lilly's Sarcoma Drug Lartruvo Fails Study

By Reuters Staff

January 22, 2019

(Reuters) - Eli Lilly and Co said on Friday its cancer treatment Lartruvo (olaratumab), approved on an accelerated basis in 2016, failed to improve patient survival in a long-term study and will no longer be prescribed.

The Phase 3 study of Lartruvo in patients with advanced or metastatic soft tissue sarcoma (STS) did not confirm the clinical benefit of the drug when used in combination with doxorubicin as compared to doxorubicin alone, the standard of care, the company said in a news release.

"Specifically, the study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population," the company reported.

Lartruvo was granted accelerated approval based on mid-stage trial data by the U.S. Food and Drug Administration and a conditional approval by the European Medicines Agency in 2016, with continued approval remaining contingent on the results of a late-stage trial.

The company said it was working with global regulators to determine the appropriate next steps for the treatment.

While these discussions are ongoing, patients with advanced or metastatic soft tissue sarcoma currently receiving Lartruvo may continue their course, if they are receiving clinical benefit, the company said.

Sarcomas are a relatively rare type of cancer that usually develop in the connective tissue of the body, including blood vessels, nerves, bones and muscles.

For patients who have not previously received Lartruvo, the trial results do not support initiating the treatment. The company said it is suspending promotion of the drug at this time.

Lilly said it plans to present full results of the ANNOUNCE study at an upcoming medical conference and will publish the results in a medical journal.