- Eli Lilly's Lartruvo failed a Phase 3 study in advanced or metastatic soft tissue sarcoma, an indication for which it gained accelerated approval back in October 2016.
- More specifically, regulators cleared Lartruvo in combination with standard-of-care chemotherapy for a subtype of adults with soft tissue sarcoma based on the median overall survival (OS) benefit seen in a Phase 2 study. Data from the larger ANNOUNCE trial released Friday, however, found the Lartruvo combo didn't significantly improve OS in that patient population compared to the chemotherapy alone.
- In a statement, Lilly said it is suspending promotion of Lartruvo and working with global regulators to determine the next steps for the drug. Patients who are experiencing a benefit may continue on the drug, though Lilly noted "the results of the Phase 3 trial do not support initiating treatment with Lartruvo ... outside of participation in a clinical trial."
Though sales of Lilly's top-selling cancer drug Alimta (pemetrexed) ticked down over the last few years, new product launches like Verzenio (abemaciclib) and Lartruvo (olaratumab) have helped to bolster Lilly's oncology business.
The ANNOUNCE results, therefore, are a setback for Lilly at a time when the pharma is trying to build a stronger foothold in the cancer field.
Lilly expects to incur a $70 million to $90 million charge this quarter in relation to Lartruvo and expects Friday's release as well as the larger Lartruvo franchise to have approximately a $0.17 per share negative impact on Lilly's full-year earnings per share guidance.
Lilly shares were trading down 3% at market's open Friday.
Lartruvo isn't the only drug to secure accelerated approval and later run into trouble in subsequent clinical study.
In May 2017, for instance, Roche's Tecentriq (atezolizumab) failed a Phase 3 trial testing it as a first-line therapy for locally advanced or metastatic urothelial cancer. The failure came just a month after the drug received accelerated approval for that indication.
A similar situation happened for Merck & Co.'s Keytruda (pembrolizumab) in recurrent or metastatic head and neck squamous cell carcinoma and Bristol-Myers Squibb's Opdivo (nivolumab) in previously treated small-cell lung cancer.
The Phase 2 study that led to Lartruvo's approval evaluated 133 patients who were put on regimens of either the drug plus doxorubicin or placebo plus doxorubicin.The investigational arm showed median OS of 26.5 months and progression free survival (PFS) of 8.2 months, whereas the control arm showed median OS of 14.7 months and PFS of 4.4 months.
ANNOUNCE had the same structure, except with an estimated enrollment of 460. Lilly noted Lartruvo didn't meet the OS primary endpoint in either the full study population or the leiomyosarcoma sub-population.