Lilly's Lartruvo approved in US for soft tissue sarcoma

Eli Lilly’s 'breakthrough' drug for soft tissue sarcoma, Lartruvo, has been approved by the FDA.

The drug has shown an enormous benefit compared to existing treatments, extending lives of patients by nearly 12 months in the pivotal trial.

Lartruvo is the first monoclonal antibody approved to treat soft tissue sarcoma (STS), and has received Fast Track, Orphan Drug and Breakthrough Therapy designations from the FDA for this indication.

Approval is based on the phase 2 portion of the pivotal JGDG trial.

Median overall survival was improved by 11.8 months in patients receiving Lartruvo plus doxorubicin compared to doxorubicin alone - rising to 26.5 months for patients receiving Lartruvo, a huge extension in life rarely seen in cancer trials.

Lilly and patients advocates are being cautious about the results, as the JGDG trial is an open label trial, with only 133 patients taking part. Nevertheless, the drug looks to be an exciting step forward in treating the disease.

"The entire sarcoma patient community is excited to have an innovative medicine approved for the treatment of advanced soft tissue sarcoma," said Bert E.Thomas IV, chief executive of the Sarcoma Foundation of America. "We are confident that the approval of Lartruvo may help these patients live longer."

The FDA granted an accelerated approval, based on immature data, and Lilly will have to provide confirmatory data.

These results should translate into healthy sales for the drug, but it isn't expected to hit blockbuster status: the five-year consensus sales forecast for Lartruvo (olaratumab) is $373.75 million, according to Cortellis Competitive Intelligence.

Lartruvo was approved combination with doxorubicin, for adults with STS with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.

It is the first FDA-approved front-line therapy for STS in four decades, and a confirmatory phase 3 trial, ANNOUNCE, is fully enrolled.

Soft tissue sarcoma is a complex disease with multiple subtypes, making it hard to diagnose and difficult to treat.

JGDG is an open-label, randomised, active-controlled study of 133 patients, which compared Lartruvo, in combination with doxorubicin chemotherapy, to doxorubicin alone in patients with STS with a histologic subtype for which an anthracycline-containing regimen was appropriate and which is not amenable to curative treatment with surgery or radiotherapy. The efficacy outcome measures were OS, progression-free survival (PFS), and objective response rate (ORR).

Lartruvo is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody that specifically binds PDGFR-α and prevents receptor activation.