According to a story from PR Newswire, the international drug developer Eli Lilly and Company recently announced the results of a Phase 3 clinical trial testing the company’s drug LARTRUVO (olaratumab) as a treatment for soft tissue sarcoma in combination with doxorubicin. This combination was tested in comparison to doxorubicin alone, and the results were disappointing. The combination failed to improve overall survival when tested against doxorubicin alone, which is a standard treatment for soft tissue sarcoma.
About Soft Tissue Sarcoma
Soft tissue sarcomas are a relatively rare form of cancer that is characterized by its tendency to develop in connective tissue. There are many different types of soft tissue sarcoma that can occur in many different materials of the body, such as muscle, fat, fibrous tissue, cartilage, peripheral nerves, lymph vessels, and blood vessels. Many soft tissue sarcomas are not associated with a definitive cause or risk factors, but some risk factors may include certain genetic disorders (such as neurofibromatosis), exposure to certain chemicals such as vinyl chloride, and radiation. These tumors often grow to considerable size before causing symptoms, which vary depending on the location. Pain in the affected area may appear as the tumor presses against other nerves, organs, or muscles. Treatment often includes surgery, chemotherapy, or radiation therapy. To learn more about soft tissue sarcoma, click here.
Future in Doubt
LARTRUVO was cleared for use under Accelerated Approval from the US Food and Drug Administration in combination with doxorubicin for treating soft tissue sarcoma. This was because of an earlier Phase 2 trial which appeared to show that this combination was able to improve overall survival. These results also resulted in condition marketing approval from the European Medicines Agency (EMA). However, maintaining this status was dependent in more clinical trial data to confirm that this combination offered increased benefit for soft tissue sarcoma patients.
The results of this trial failed to confirm that LARTRUVO and doxorubicin were any better than doxorubicin on its own. Eli Lilly is in communication with regulatory agencies to determine the next steps for the drug, but approval looks unlikely at this stage. Patients who are currently using the combination may continue to do so if they are seeing benefit.