Just a few days after Eli Lilly’s embarrassing admission that its quick-to-market soft tissue sarcoma drug Lartruvo (olaratumab) flopped in a Phase III confirmatory study, European regulators are recommending that doctors find some other drug to use against the disease.
According to the regulators, the drug combined with doxorubicin barely edged out doxorubicin alone, not close to a statistically significant outcome. Overall survival was 20.4 months for the combo versus 19.7 months for doxorubicin, with a dismal hazard ratio of 1.05. Chemo alone actually edged out the combo in progression-free survival; 6.8 months compared to 5.4 months.
Launched in 2016, the EMA says that after top-line data underscored the drug’s failure to improve either progression-free or overall survival rates, no new patients should get this therapy. Eli Lilly $LLY said at the end of last week that it is ending promotions on the drug and analysts are using it as a test case, waiting to see if the FDA will follow through and formally yank it off the market.
The EMA added that regulators want physicians to review cases on about 1,000 patients taking the drug, and stop its use unless they believe it’s providing a benefit. That opinion is certain to quickly chill the existing market on both sides of the Atlantic.
Lartruvo’s approval was based on Phase II data, a now-popular strategy that has accelerated the OK on scores of oncology drugs. Even with the transatlantic setback for Lilly, which has been working to build some momentum in its cancer division with the recent $8 billion Loxo buyout, the failure in Phase III is unlikely to blunt the FDA’s pedal-to-the-medal approach on cancer drug reviews.
Unless, of course, the government shutdown forces the FDA to slow and stop.
It was a different story back in the fall of 2016, when the FDA first OK’d the drug — the first new therapy for soft tissue sarcoma in 40 years. The drug targets PDGF receptors which are linked to tumor growth.
Lilly, which has begun to rack up a few new drug approvals after a long drought in the clinic, was able to present phase II stats showing that the median survival rate for patients taking olaratumab hit 26.5 months for the combo compared to 14.7 months for patients who received doxorubicin alone. Investigators also posted a median progression-free survival time of 8.2 months for the combo compared to 4.4 months for patients who received only doxorubicin. Tumor shrinkage registered at 18.2 percent against 7.5 percent.
Clinicaltrials.gov lists 5 ongoing studies for the drug.
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