The recently reported results of ANNOUNCE, the phase III study of olaratumab in combination with doxorubicin in patients with advanced or metastatic soft-tissue sarcoma, did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin, a standard-of-care treatment. Specifically, the study did not meet the primary endpoints of overall survival in the full study population or in the leiomyosarcoma (LMS) subpopulation.
There was no difference in survival between the study arms for either population. Olaratumab was well-tolerated; no new safety signals were identified, and the safety profile was comparable between treatment arms. Eli Lilly and Company plans to present the ANNOUNCE data at an upcoming medical conference, and the results will be published in a medical journal.
Olaratumab in combination with doxorubicin previously showed an overall survival benefit in soft-tissue sarcoma in a 133-patient, United States–only, randomized phase II trial, which led to accelerated approval by the U.S. Food and Drug Administration and conditional marketing authorization by the European Medicines Agency. Continued approval is contingent upon verification of clinical benefit in a confirmatory trial.
As ANNOUNCE did not confirm clinical benefit, Lilly is working with global regulators to determine the appropriate next steps for olaratumab. While these discussions are ongoing, patients who are currently receiving olatatumab may, in consultation with their physician, continue their course of therapy if they are receiving clinical benefit. For patients who have not previously received olaratumab, the results of the phase III trial do not support initiating treatment with olaratumab in patients with soft-tissue sarcoma, outside of participation in a clinical trial. At this time, Lilly is suspending promotion of olaratumab.
“Lilly was surprised and disappointed that olaratumab did not improve survival for patients with advanced soft-tissue sarcoma in this study,” said Anne White, President, Lilly Oncology, in a statement. “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. We are thankful for the patients and physicians who have participated in the ANNOUNCE study.”
Olaratumab is also being studied in an ongoing global, randomized, double-blind, placebo-controlled phase II trial in advanced soft-tissue sarcoma in combination with gemcitabine and docetaxel.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.