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Lilly cancer drug with accelerated approval fails in confirmatory trial

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A drug that won accelerated approval from the Food and Drug Administration two years ago has failed in a trial designed to prove its efficacy.

Indianapolis-based Eli Lilly & Co. said Friday that a Phase III trial of the drug, Lartruvo (olaratumab), in patients with advanced or metastatic soft-tissue sarcoma, also known as STS, did not confirm the benefit shown in the randomized Phase II trial that led to the accelerated approval.

Lilly’s shares opened down 2.9 percent Friday on the New York Stock Exchange.

The drug was approved in 2016 in combination with doxorubicin for STS patients who had histological subtypes of the cancer that could be treated with a regimen containing an anthracycline chemotherapy such as doxorubicin. The approval was based on a 133-patient Phase II study that showed a statistically significant improvement in median overall survival, with a median OS of 26.5 months for the two-drug combination, compared with 14.7 months for doxorubicin alone.

But the results from the Phase III trial, titled ANNOUNCE, showed no difference in overall survival between patients receiving Lartruvo with doxorubicin and those receiving doxorubicin alone, whether for the broader STS population or for patients with a histological subtype called leiomyosarcoma. Full approval for Lartruvo was contingent upon its success in ANNOUNCE.

Lilly said it is working with regulators to determine the next steps for the drug. Generally, when a confirmatory trial fails to verify the benefit of a drug, the approval is withdrawn or the label is changed. Lilly advised physicians to keep patients on Lartruvo if they were benefiting, but not to initiate new patients on the drug.

The news comes as the company has sought to expand its presence in oncology, in particular with last week’s acquisition of Loxo Oncology for $8 billion.

A 2017 study by researchers at Harvard Medical School and the London School of Economics found that the FDA had given accelerated approval to 22 drugs for 24 indications, 19 of which were in cancers. After at least three years of follow-up, half had completed confirmatory studies. Among those that had not completed confirmatory studies, at least one had failed, been terminated or was delayed. In eight indications, clinical benefit had not been confirmed at least five years after the FDA granted accelerated approval.

Photo: pictafolio, Getty Images

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