Eli Lilly and Co has announced that its cancer treatment Lartruvo, which had won conditional approval, failed to improve patient survival in a long-term confirmatory study and will no longer be prescribed. No new US patients will be started on the drug and Lilly is suspending promotion of the medicine, the company is quoted in a Reuters Health report a saying.
Lartruvo won accelerated approval in 2016 in the US and conditional approval in Europe based on results from a promising mid-stage trial. But its continued approval was contingent on the results of a larger, late-stage trial confirming the drug’s benefits. But Lilly said Lartruvo combined with the standard-of-care chemotherapy doxorubicin did not prolong survival more than doxorubicin alone in patients with advanced soft tissue sarcoma.
Lilly oncology chief Anne White is quoted in the report as saying the results were “completely unexpected.”
The disappointing outcome reflects the risk involved when drugs are approved based on smaller trials with promising data. “In a sense, this is the way it’s supposed to work,” White said. “You do that confirmatory study. Obviously, there are times when it doesn’t work out.” Lartruvo will continue to be available to patients who appear to be benefiting from it as global regulators determine the next steps for the treatment, White said.
The report says the Lartruvo news is a major setback to Lilly’s efforts to significantly boost its presence in oncology, as evidenced by its recent announcement that it would buy Loxo Oncology Inc for $8bn to acquire its cancer drugs that target rare genetic mutations.
Lilly in the past had avoided large deals, preferring to develop its own drugs. But, the report says, the Loxo deal, the biggest acquisition in Lilly’s 143-year history, followed last year’s $1.6bn purchase of Armo Biosciences, a developer of immunotherapy drugs.
“Given Lilly’s strategic focus on oncology, this increases the probability that Lilly will make more oncology acquisitions to improve scale,” BMO Capital Markets analyst Alex Arfaei said of the Lartruvo setback.
[link url="https://www.reuters.com/article/us-lilly-study/lilly-cancer-drug-fails-key-trial-will-no-longer-be-prescribed-idUSKCN1PC1B1"]Reuters Health report[/link]