On the heels of a surprise trial failure for Eli Lilly's soft tissue sarcoma drug Lartruvo, European officials have barred new patients, putting the drug's future in jeopardy there.
In a phase 3 trial in advanced or metastatic soft tissue sarcoma that reported out last week, patients taking Lartruvo and doxorubicin didn’t outlive those using doxorubicin alone. The Lartruvo patients lived a median 20.4 months, compared with 19.7 months in the doxorubicin group, the European Medicines Agency said Wednesday, releasing numbers that Lilly had so far kept quiet.
Conditionally approved on the back of phase 2 data showing it could help patients live significantly longer—26.5 months versus 14.7 months—and hold off cancer progression better than doxorubicin alone, Lartruvo needed a confirmation in phase 3 to keep its European green light. And now European officials say no new patients should start on the drug.
Lartruvo won an accelerated approval in the U.S. based on the same phase 2 data. Lilly said last week that, in light of the phase 3 failure, it would stop promoting Lartruvo in the U.S. Not only did the Lartruvo combo fail to prolong patients' lives in the earlier trial, it also fell short at holding off disease progression better than doxorubicin alone.
EMA says it'll communicate the developments to doctors and further analyze the results. In the meantime, doctors may continue using the med for patients who are seeing a benefit, officials said.
The trial failure marks a setback for Lilly as it works to build up in oncology. The company just spent $8 billion on Loxo Oncology, nabbing the approved “tumor agnostic” TRK inhibitor Vitrakvi and several pipeline meds.
Meanwhile, as the U.S. government is still in a partial shutdown, it remains to be seen how the FDA will react to Lartruvo's phase 3 failure. After reporting the results, Lilly said it’s “working with global regulators to determine the appropriate next steps” for the med.
The company said it would take a pre-tax charge of $70 million to $90 million this quarter after the failure. For the year, it expects a 17-cent hit to earnings per share.
Lartruvo launched in 2016; the drug delivered $203 million in sales in 2017 and $221 million through the first nine months of 2018.