Hanmi Pharmaceutical Co. plans to present additional data from a global phase 3 clinical trial for Oraxol, an oral anticancer drug. The company’s move raises expectations for commercialization as it has recently disclosed encouraging results from the phase 3 clinical trial.
Hanmi Pharmaceutical announced on Sept. 24 that its U.S. partner, Athenex, plans to release additional data from the global phase 3 clinical trial for Oraxol at the European Society for Medical Oncology (ESMO) 2019 in Barcelona, Spain, on Sept. 27 and San Antonio Breast Cancer Symposium (SABCS) 2019 in San Antonio, Texas, on Dec. 10.
During the ESMO, Athenex will hold three poster sessions – phase Ib study of the combined use of Oraxol and Cyramza for patients with gastric or esophageal cancer for whom chemotherapy did not work, a comparative study of bioequivalence of Oraxol and intravenous paclitaxel once a week for patients with advanced solid tumor, and a pilot study (KX-ORAX-010) on Oraxol in treating cutaneous angiosarcoma.
At the SACBS, the company will present additional data from the phase 3 global clinical trial comparing Oraxol with intravenous paclitaxel administration for metastatic breast cancer patients.
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 (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) 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. Therefore, we expect to expand the scope of efficacy,” Athenex CEO Johnson Lau said. “We plan to submit a new drug application (NDA) in the first half of next year through ongoing patient follow-up and prompt FDA meetings.”
Oraxol is an oral dosage form of the widely used intravenous administered tubulin-stabilizing chemotherapeutic agent paclitaxel based on Hanmi Pharmaceutical’s Orascovery platform technology. The company licensed out the drug to Athenex listed on the NASDAQ in 2011.