No new patients should take Lilly's cancer drug Lartruvo, say regulators

Regulators on both sides of the Atlantic have ruled that no new patients should start treatment with Eli Lilly’s Lartruvo (olaratumab) for soft tissue sarcoma, after a study that was supposed to confirm its efficacy failed.

Late last week the FDA joined the European Medicines Agency by ruling that no new patients should begin courses of treatment with Lartruvo in combination with doxorubicin, except in clinical trials.

The FDA granted Lartruvo an accelerated approval in October 2016 on the basis of data from a smaller trial involving 133 patients and required further data from a larger study to confirm that it improved survival.

The EMA authorised the drug the following month, granting a conditional approval pending confirmatory data from a larger study.

But Lilly said that the phase III ANNOUNCE study earlier this month did not meet its overall survival endpoints compared with chemotherapy alone.

It failed to achieve its main goal of improving overall survival (OS), and Lilly has announced it has ceased promoting the drug.

In patients treated with Lartruvo and doxorubicin OS was 20.4 months, compared with 19.7 months for doxorubicin alone.

In the leiomyosarcoma sub-population OS was 21.6 months on the Lartruvo combination compared with 21.9 months for doxorubicin.

Progression-free survival for patients taking Lartruvo and doxorubicin was 5.4 months, compared with 6.8 months on doxorubicin.

The FDA said it is currently reviewing data and working with Lilly to determine the next steps.

The message was similar from the EMA – it said that while full results from ANNOUNCE are awaited no new patients should start treatment with the medicine.

Patients already being treated may continue with the drug if they appear to benefit. Around 1,000 patients are currently being treated with Lartruvo in the EU, the EMA said.

The EMA pointed out that no new side effects have emerged in the study.