LSU Health New Orleans Part of International Medical First

LSU Health New Orleans clinical researchers helped develop a new treatment for endometrial cancer that was a medical first. It is the combination of two drugs that were already approved for other cancers, and investigators from LSU Health New Orleans Stanley S. Scott Cancer Center clinically tested both of them. On September 17, the U. S. Food and Drug Administration and the Australian Therapeutic Goods Administration simultaneously gave accelerated approval to the combination of Lenvima (lenvatinib) and Keytruda (pembrolizumab) for the treatment of patients with a specific kind of advanced endometrial carcinoma. It is the first time that the FDA has approved a new treatment collaboratively with another country.

LSU Health investigators, supported by the Al Copeland Foundation, participated in the clinical trial of pembrolizumab, which led to its approval as a treatment for advanced Merkel Cell Carcinoma.

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Agustin Garcia, MD, Professor of Medicine and Chief of Hematology/Oncology, is one of the authors of a study that first reported the efficacy of lenvatinib alone for endometrial cancer.

“Although this was an important finding, it was evident that lenvatinib alone was not effective enough,” noted Dr. Garcia, who also holds the Charles W. McMillin and Richard Paul Grace Chair in Cancer Research at LSU Health New Orleans School of Medicine. “This led to the development of a follow-up study looking into the combination of both drugs.”

The study was a phase II, multi-institutional trial sponsored by Eisai and supported by Merck that enrolled 94 patients. The FDA reports that “of the 94 patients, 10 patients (10.6% of responders) had a complete response, or disappearance of all lesions on imaging, and 26 patients (27.7% of responders) had a partial response, or shrinkage of lesions by at least 30%, leading to an objective response rate of 38.3%. Of these, 25 patients (69% of responders) have a duration of response of greater than 6 months.”

LSU Health is currently participating in a confirmatory multi-institutional international trial that has suspended enrollment in the U.S. based on the early FDA approval.

“The newly approved drug combination is for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation,” said Garcia. “This is important news for women with recurrent endometrial cancer who are now able to receive a treatment that seems to be much better than our existing drugs.”

Endometrial cancer is the most common gynecological cancer, with more than 60,000 women diagnosed every year in the United States. Approximately 12,000 women die every year from this cancer. Conventional treatment involves surgery, radiation and chemotherapy. However, if cancer relapses after the initial treatment, there are limited treatment options.

“No drug had been approved by the FDA for the treatment of recurrent endometrial cancer in more than 20 years,” Garcia remarked.