LONDON, 18 Jan (APM) - Eli Lilly said on Friday that it has suspended promotion for Lartruvo (olaratumab) as a treatment for soft tissue sarcoma after it failed to impress in a confirmatory Phase III study.
Lartruvo was approved in 2016 under accelerated approval in the U.S. and conditional approval in the EU for use in combination with doxorubicin to treat advanced soft tissue sarcoma (APMHE 50073
, APMHE 50386
Both early approvals were based on positive Phase II results, with a requirement for Lilly to provide details from the Phase III ANNOUNCE study when they were ready.
However, this trial did not meet the primary endpoints of significant improvement in overall survival (OS) in either the full study population or in the leiomyosarcoma (LMS) sub-population.
This puts the future of the drug in this patient population in doubt, with Lilly saying in a statement
that it is working with global regulators to determine the appropriate next steps for Lartruvo.
Anne White, president, Lilly Oncology, added: "Lilly was surprised and disappointed that Lartruvo did not improve survival for patients with advanced soft tissue sarcoma in this study.
“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.”
Following its approval in 2016, the drug has gone on to be a fairly successful product for Lilly, with sales of $221.2 million for the first nine months of 2018.
Lilly said in Friday’s statement that it expects to incur a charge of $70-$90 million in the first quarter of 2019 related to the drug. It added that it anticipates that this will have an impact of approximately $0.17 per share on Lilly's full-year 2019 earnings-per-share guidance.
Shares were down 2% in premarket trading on Friday, according to Thomson Reuters.
Lilly said that while discussions with regulators are ongoing on its future, patients who are currently receiving Lartruvo may, in consultation with their physician, continue their course of therapy if they are experiencing clinical benefit.
It added that for patients who have not previously received the drug, the results of the Phase III trial do not support initiating treatment with Lartruvo in patients with soft tissue sarcoma, outside of participation in a clinical trial.
“At this time, Lilly is suspending promotion of Lartruvo.”
Lartruvo is also being studied in an ongoing Phase II trial in advanced soft tissue sarcoma in combination with gemcitabine and docetaxel. Lilly did not say whether this study will be impacted.