The US FDA and the European Medicines Agency (EMA) are recommending that no new patients with advanced soft tissue sarcoma start treatment with olaratumab (Lartruvo) due to lack of efficacy.
The decisions are based on results from the ANNOUNCE study that showed olaratumab in combination with doxorubicin offers no survival benefit over doxorubicin alone.
Clinicians may consider continuing patients who are already on the drug if they appear to be benefiting from it.
“Based on the information available so far, there are no new safety concerns with the medicine, with side effects reported with the combination being similar to those with doxorubicin alone,” the EMA said.
2/3 #FDA recommends patients who are currently receiving Lartruvo consult with their healthcare provider about whether to remain on the treatment and also recommends that Lartruvo not be initiated in new patients outside of an investigational study. https://t.co/D43xMFwaBT
— Jennifer Rodriguez (@FDASpox) January 24, 2019
The findings are a disappointment after earlier results supported olaratumab’s accelerated approval by both the EMA and the US Food and Drug Administration (FDA) in 2016.
Following their release, Eli Lilly have said they are suspending promotion olaratumab.
President of Lilly Oncology Anne White said the company was ‘surprised and disappointed that Lartruvo did not improve survival for patients with advanced soft tissue sarcoma’.
“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,” she said.
The EMA said the study did not meet its primary objective to prolong overall survival (HR: 1.05; 20.4 v 19.7 months for olaratumab plus doxorubicin v doxorubicin respectively) or in a subgroup of patients with leiomyosarcoma (HR: 0.95; 21.6 v 21.9 months).
“Additionally, no benefit was shown in terms of prolonging progression-free survival in the overall population (HR: 1.23; median 5.4 months for Lartruvo plus doxorubicin versus 6.8 months for doxorubicin), which was one of the secondary objectives of the study.”
A spokesperson for Lilly Australia told the limbic there were three Australian sites involved in the ANNOUNCE study.
“The study has been completed and patients on study treatment who continue to experience clinical benefit and no undue risks may, after consulting with their treating physician, continue to receive olaratumab,” they said.
Olaratumab was the first medicine to be granted a fast track approval by the TGA under the new provisional approval pathway for promising drugs, which came into effect on 20 March 2018. The provisional pathway allows innovative drugs to be approved on the basis of preliminary clinical data “where there is the potential for a substantial benefit to Australian patients.”