Eli Lilly and Co. (LLY) announced Friday that results of its the Phase 3 drug trial of Announce, a treatment for sarcoma, failed to meet its primary endpoint of overall survival.
The cancer drug, a combination of Lartruvo and doxorubicin for patients with advanced or metastatic soft tissue sarcoma, didn't confirm further clinical benefits compared with using doxorubicin alone, a standard of care treatment.
Eli Lilly stock fell 2.2% to $116.59 at the close of trading on Friday.
Announce previously showed benefits in a 133-patient randomized Phase 2 trial. That led Announce to accelerated approval by the U.S. Food and Drug Administration and conditional marketing authorization by the European Medicines Agency.
The biotechnology giant said it expects to incur a charge in the first quarter of 2019 related to Lartruvo of possibly $70 million to $90 million, abut 10 cents a share after taxes. he failed trial will also have an impact of approximately 17 cents a share on full-year 2019 earnings, the company said.
The company said it was working with global regulators to determine the appropriate next steps for Lartruvo. Lilly said it suspended promotion of Lartruvo.
"Lilly was surprised and disappointed that Lartruvo did not improve survival for patients with advanced soft tissue sarcoma in this study," Anne White, president of Lilly Oncology, said in a statement. "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. We are thankful for the patients and physicians who have participated in the Announce study."