The ambitious cancer therapy program of Eli Lilly and Company (LLY) suffered a setback Friday after a formulation developed by the drug maker for the treatment of malignant tumor affecting soft tissues failed in an advanced-stage clinical trial. Lartruvo (olaratumab), which was tested in patients suffering from metastatic soft tissue sarcoma, was found to be ineffective in reducing the severity of the condition.
In the study, the therapy did not achieve the primary endpoint of overall survival. The negative outcome came as a surprise to the management as the drug had earlier received accelerated approval from the FDA and conditional marketing approval from the European Medicines Agency after an early-stage study showed it improved overall survival in patients.
“Lilly was surprised and disappointed that LARTRUVO did not improve survival for patients with advanced soft tissue sarcoma in this study. Lilly is committed to helping people who have soft tissue sarcoma and we will carefully study the detailed data in an effort to better understand the different results between the two trials,” said Lilly Oncology president Anne White.
Earlier, Lartruvo had received accelerated approval from the FDA and conditional marketing approval from the European Medicines Agency
Meanwhile, there is uncertainty among the company’s oncology team over the next step to be taken with regard to the drug as its clinical benefits have not been verified in a confirmatory trial. Lilly plans to present data from the study at an unspecified medical conference and publish the results later.
In the phase-III study, Lartruvo – a platelet-derived growth factor receptor alpha blocking antibody – was administered in the patients in combination with chemotherapy drug doxorubicin. The study assumes significance considering the complexities involved in the diagnosis and treatment of soft tissue sarcoma, which has many subtypes.
As part of strengthening its cancer drug portfolio, Lily acquired Loxo Oncology earlier this month in an $8-billion deal. The company expects to benefit from Loxo’s FDA-approved cancer drug Vitrakvi, which was developed and commercialized in partnership with Bayer. In addition, LOXO-292, which was assigned breakthrough status by the FDA after successful initial trials, is expected to enhance Lily’s line-up.
Reflecting investors’ disappointment over the negative outcome of the trial, Lilly’s shares dropped about 4% Friday, retreating from Thursday’s record high. In the past twelve months, the stock gained about 35% as the drug maker achieved some of its operational goals.