Back in 2016, Lilly won FDA accelerated approval for its soft tissue drug olaratumab on the basis of encouraging data from a small 133-patient mid-stage study, but on Friday a larger, confirmatory trial meant to cement the approval showed that the treatment failed to help patients live longer, which means the US health regulator can rescind its endorsement of the drug.
The drug, sold as Lartruvo, had won the FDA nod in combination with the chemotherapy doxorubicin as a first-line treatment for a subset of patients with the disease, which had seen no new approvals in decades. By the third quarter of 2018, Lilly had raked in $221.2 million in Lartruvo sales last year.
The confirmatory Phase III trial — ANNOUNCE — tested Lartruvo in combination with doxorubicin, versus doxorubicin monotherapy in patients with advanced or metastatic soft tissue sarcoma. The study did not meet the main goal of improving overall survival in the patient population, including the subset of leiomyosarcoma patients — there was no difference in survival between the study arms for either population, the company said.
Data from the previous, positive Phase II trial had helped Lilly secure accelerated approval in the United States, and conditional approval in Europe. But those approvals were contingent on favorable ANNOUNCE results confirming its benefit, and now the company will talk to regulators to determine the next steps for the drug.
For now, the drugmaker has suspended Lartruvo promotion, and expects to incur a pre-tax charge in the range of $70 million to $90 million (or $0.10 per share, after tax) in the first quarter of 2019.
“Lilly was surprised and disappointed that LARTRUVO did not improve survival for patients with advanced soft tissue sarcoma in this study,” said Anne White, president of Lilly Oncology in a statement. Lilly’s $LLY shares slipped about 3% pre-market.
The drug is currently also being tested in combination with gemcitabine and docetaxel in a separate Phase II trial in advanced soft tissue sarcoma patients.
The failure follows Lilly’s announcement this month to swallow Loxo Oncology for $8 billion. According to a SEC filing posted on Thursday, Lilly executives were looking for a swift deal when they sat down with Loxo CEO Josh Bilenker five days ahead of Christmas. They were willing to fork out $230 a share for the smaller company, in a hurry to get the deal done in time for the JPMorgan extravaganza. There were no others bidders for the company, but in order to hasten the buyout, Lilly agreed eventually to pay $235 per Loxo share, allowing for the acquisition to be revealed on January 7.
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