Results from Lilly’s Phase III trial into Lartruvo demonstrated it didn’t show an improvement in overall survival compared to the standard of care. Credit: Shutterstock.

The US Food and Drug Administration (FDA) has stated that Eli Lilly’s Lartruvo (olaratumab) therapy should not be initiated for soft tissue sarcoma patients and patients already taking the drug should consult their doctors about continuing treatment.

This follows a similar announcement by the European Medicines Agency (EMA) made on 23 January 2019.

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These decisions were based upon Lilly’s ANNOUNCE Phase III trial, which failed to confirm the clinical benefit Lartruvo had shown in a 2016 Phase II trial.

The 2016 trial had led to the drug’s accelerated approval by both the FDA and the EMA and one condition for Lartruvo’s continued approval was post-marketing confirmation studies demonstrating its clinical benefit.

In a statement, the FDA said: “In light of this information, the FDA recommends that patients who are currently receiving Lartruvo should consult with their health-care provider about whether to remain on the treatment.

“The FDA also recommends that Lartruvo should not be initiated in new patients outside of an investigational study.”

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In the ANNOUNCE study, Lartruvo in combination with the standard of care doxorubicin failed to meet the primary endpoint of improving overall survival compared to doxorubicin alone in either the full study population or the leiomyosarcoma sub-population.

This study did not identify any new safety concerns with the drug; it was well tolerated by participants.

Lilly Oncology president Anne White said: “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. We are thankful for the patients and physicians who have participated in the ANNOUNCE study.”

Soft tissue sarcoma is a group of rare cancers; according to the US-based Sarcoma Alliance, it comprises approximately 1% of all cancers diagnosed globally.