Eli Lilly & Co. (NYSE: LLY) said on Friday its cancer treatment Lartruvo, approved on an accelerated basis in 2016, failed to improve patient survival in a long-term study and will no longer be prescribed, driving shares down 3%.
The Company said it expects to take a charge in the first quarter of 2019 as a result of the failure and will have an impact on its full-year 2019 forecast.
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.
On Friday, Lilly said the study did not confirm the clinical benefit of Lartruvo, used in combination with the standard-of-care chemotherapy doxorubicin, when compared to doxorubicin alone.
“Lilly was surprised and disappointed that Lartruvo didn’t improve survival for patients with advanced soft tissue sarcoma in this study,” said Anne White, President of Lilly’s oncology division in prepared remarks. White said Lilly will continue to carefully look at the results of the study to help them better understand the treatment of sarcoma.
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 that usually develop in the connective tissue of the body, including blood vessels, nerves, bones and muscles.
The Company said it was working with global regulators to determine the appropriate next steps for the treatment.
Lartruvo was expected to bring in USD 374.5 Million in 2019, according to IBES data from Refinitiv.
The Company said it expects to take a first-quarter charge, related to Lartruvo, in the range of USD 70 Million to USD 90 Million pre-tax, or about 10 cents per share after tax. Lilly also said it expects the trial failure to have an impact of about 17 cents per share on its full-year 2019 earnings forecast, but does not see a change in its 2020 minimum financial goals.
Last week, Lilly said it would buy Loxo Oncology Inc. for USD 8 Billion to expand its presence in the lucrative oncology market.