On Thursday, regulators with both the FDA and EMA announced that patients prescribed the drug should ask their doctors if it is wise to continue taking it. This comes after Lartruvo failed to hit endpoints in a Phase III study of advanced or metastatic soft tissue sarcoma.
Jonathan Weiss / Shutterstock.com
After Eli Lilly’s Lartruvo (olaratumab) failed to hit endpoints in a Phase III study of advanced or metastatic soft tissue sarcoma (STS), federal regulators said the medicine shouldn’t be used In new patients and are raising questions about whether or not patients already using the medicine should continue its use.
On Thursday, one week after Eli Lilly reported the failure of Lartruvo, Bloomberg reported that regulators with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) announced that patients prescribed the drug should ask their doctors if it is wise to continue taking it.
In the Phase III study, Lartruvo, a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody, the drug failed to hit the end goal of improving overall survivability. The drug is designed to bind to PDGFR-α and prevent receptor activation. In the Phase III study, Lartruvo, in combination with the chemotherapy drug doxorubicin, did not meet overall survival in either the full study population or in a sub-population of patients with leiomyosarcoma. As BioSpace reported last week, there was no difference in survival between the study arms.
That was a blow to the drug, particularly following positive Phase II trial results. The results were positive enough in the mid-stage trial that the FDA awarded the drug the drug accelerated approval and the EMA granted conditional marketing authorization for STS.
But, with the failure of the Phase III ANNOUNCE trial, regulators are cautious about its continued use.
In a statement first reported by Bloomberg, the FDA said it recommends that patients who are currently receiving Lartruvo should consult with their health-care provider about whether to remain on the treatment. Additionally, the FDA recommends that Lartruvo should not be initiated in new patients outside of an investigational study. One day prior to the FDA’s announcement, the EMA made a similar proclamation, Bloomberg said.
With the Phase III failure, Indianapolis-based Eli Lilly said it is working with federal regulators to determine a path forward for Lartruvo as a treatment for STS.
According to the American Cancer Society, there were about 13,000 newly diagnosed cases of soft tissue sarcoma in 2018. About 5,000 of those patients will likely die from the disease, which is marked by multiple subtypes. Those disease subtypes make it a more difficult disease to treat. As Eli Lilly noted, for decades, there have been no first-line therapeutic advancements for STS that have improved overall survivability.
Lartruvo is also being studied in an ongoing global, randomized, double-blind, placebo-controlled Phase II trial in advanced STS in combination with gemcitabine and docetaxel.
Shares of Eli Lilly are down slightly this morning, trading at $114.69 as of 10:45 a.m.
