Eli Lilly reported that its study of Lartruvo (olaratumab), in combination with doxorubicin, failed to boost survival rates against standard care in patients with advanced or metastatic soft tissue sarcoma.
Last week, both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) acted quickly to advise patients and doctors that no new patients should begin the combination treatment.
Study results released ahead of a full readout from Lilly, showed there was no difference in survival rates when Lartruvo was used in combination with doxorubicin or with doxorubicin alone.
Lartruvo had previously received conditional marketing authorisation by both the EMA and FDA based on a smaller study sample that indicated efficacy with the condition that supplementary data be provided after approval to confirm the results.
With Lilly unable to do this, the regulators recommended that no new patients should start treatment with the medicine. The EMA recommended continued use only if the healthcare provider observed benefits from the treatment; the FDA advised use of the treatment only if patients are already involved in a clinical trial.
"Lilly was surprised and disappointed that Lartruvo did not improve survival for patients with advanced soft tissue sarcoma in this study," said Anne White, president of Lilly Oncology.
White continued by stating that Lilly will study the detailed data from the clinical trial readout, which both regulators said will needed to be reviewed in order to determine the next course of action.
The EMA confirmed that there are no additional safety concerns for the combination treatment, which shares a similar safety profile to doxorubicin when used alone.
As a result of the trial failure, Lilly noted that it expects to take a charge of approximately $70m (€61.2m) to $90m (€78.2m). It will also suspend promotion of Lartruvo.