Hanmi Pharmaceutical said that Athenex, its U.S. partner, plans to present additional studies for Oraxol, an oral anticancer drug, at the European Society for Medical Oncology (ESMO) 2019 and San Antonio Breast Cancer Symposium (SABCS) 2019.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
During ESMO, which will kick off on Friday, Athenex will hold three poster sessions -- phase Ib study of the combined use of Oraxol and Cyramza in patients with gastric or esophageal cancer who failed chemotherapy, a comparative study of bioequivalence of Oraxol and intravenous paclitaxel in patients with advanced solid tumor, and a pilot study of Oraxol in treating cutaneous angiosarcoma.
At SACBS, the company will release additional data from phase 3 of the global clinical trial comparing Oraxol with intravenous paclitaxel administration for metastatic breast cancer patients.
Oraxol is an oral dosage form of the widely used intravenous administered tubulin-stabilizing chemotherapeutic agent paclitaxel. The company licensed out the drug to Athenex in 2011.
The presentation at the two conferences comes after Athenex successfully met its primary efficacy endpoint with statistically significant improvement over IV paclitaxel in a phase 3 study of metastatic breast cancer in August. The company recorded a significant decrease in the objective response rate, duration of response, progression-free survival, and overall survival for Oraxol compared with intravenous paclitaxel.
“Oraxol has the potential to become an anticancer drug with a new mechanism and continues to accumulate extensive clinical data to support it,” Athenex CEO Johnson Lau said. “We plan to submit a new drug application in the first half of next year through ongoing patient follow-up and prompt FDA meetings.”
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