Shares in Eli Lilly were down in early trading after the US drugmaker said its cancer drug Lartruvo failed to meet main survival goals in a late stage trial, prompting the company to stop promoting the already-marketed medicine.
Lartruvo (olaratumab) is already approved in the US for advanced soft tissue sarcoma – but only from data from a smaller trial under the FDA’s accelerated approval scheme for badly-needed drugs. The company needed the data from the ANNOUNCE study to confirm that it worked in a larger group of patients.
Unfortunately, the expected results did not materialise: Lilly said Lartuvo in combination with chemotherapy had missed survival endpoints in the trial using chemotherapy alone as a comparator, in patients with advanced or metastatic soft tissue sarcoma.
Lilly needed the drug to improve overall survival in the fully study population and in a group of patients with leiomyosarcoma for the trial to be considered a success. But initial results show there was no difference in survival between the study arms for either population. There were however no new safety signals identified and the safety profile was comparable between treatment arms.
Lilly said that as ANNOUNCE did not confirm clinical benefit, it is working with the FDA and other regulators including the European Medicines Agency to decide “appropriate next steps” for Lartruvo.
Lartruvo in combination with doxorubicin previously showed an overall survival benefit in STS in a 133-patient, US-only, randomised phase 2 trial, which led to accelerated approval by the FDA in 2016 and a conditional marketing authorisation by the European Medicines Agency. While these discussions are ongoing, patients receiving the drug may still receive it if they are experiencing a clinical benefit, in consultation with their doctor. However Lilly will cease promoting Lartruvo, which generated sales of $77 million in Q3.
Lilly expects to incur a charge in the first quarter of 2019 as a result. The exact amount of the charge has not yet been determined, but is estimated to be in the range of $70 million to $90 million before tax, or around $0.10 per share after tax. Lilly forecast this to have an impact of approximately $0.17 per share on Lilly’s full-year 2019 earnings per share guidance.
Lartruvo is also being studied in an ongoing global, randomised, double-blind, placebo-controlled Phase 2 trial in advanced STS in combination with gemcitabine and docetaxel.
The company will provide a further update in upcoming Q4 and full year results, as well as further information about its recent acquisition of cancer drugs firm Loxo.