On May 29, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reportted interim data from an ongoing Phase II clinical trial in which oral paclitaxel and encequidar ("Oral Paclitaxel", formerly known as Oraxol) monotherapy showed encouraging efficacy and tolerability in elderly patients with unresectable cutaneous angiosarcoma, an aggressive malignancy with poor prognosis (Press release, Athenex, MAY 29, 2020, View Source [SID1234573876]). The interim results are being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, being held from May 29 to 31, 2020, and reflect data from 22 evaluable patients out of 26 enrolled patients (16 males and 10 females, median age 75 years (range: 49-93 years)).

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The interim data showed a clinical benefit rate (CR+PR+SD) of 100% in 22 evaluable patients receiving Oral Paclitaxel treatment, who reached their first post treatment efficacy evaluation. All 22 patients experienced reduction in tumor size. Complete responses (CR) were observed in 27.3% of patients (6/22), partial responses (PR) were observed in 22.7% of patients (5/22), and stable disease was observed in 50% of patients (11/22). Oral Paclitaxel has been generally well tolerated in this predominantly elderly population.

"The responses to Oral Paclitaxel observed thus far are very encouraging, especially given the highly aggressive nature of cutaneous angiosarcoma and the lack of approved treatment options for this disease," said lead investigator Vinod Ravi, MD, MBA, associate professor in the Department of Sarcoma Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas. "Oral Paclitaxel appears to be well tolerated, even in older patients. We look forward to continue advancing the study, which will allow us to further characterize this potentially valuable treatment option for angiosarcoma."

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "The interim data in this Phase II trial add to the growing body of evidence supporting the potential broad clinical utility of Oral Paclitaxel, which has already shown strong clinical data in a Phase III pivotal trial in patients with metastatic breast cancer."

The interim Phase II data, presented as Poster #11517 A Phase II Study of Oral Paclitaxel with Encequidar in the Treatment of Unresectable Cutaneous Angiosarcoma will be part of the Sarcoma Highlights Session on Sunday, May 31 at 3:30pm ET, at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. A copy of the poster presentation is available on Athenex’s website here.

About the Phase II Study of Oral Paclitaxel in Angiosarcoma

This single-arm Phase II study evaluates the activity, safety and tolerability of Oral Paclitaxel administered once daily for three consecutive days per week in patients with unresectable cutaneous angiosarcoma. Enrollment is ongoing at sites in the U.S., United Kingdom, Hong Kong and Taiwan, with a planned total enrollment of 43 subjects. For more information, refer to ClinicalTrials.gov Identifier: NCT03544567.

In April 2018, the U.S. Food and Drug Administration granted an Orphan Drug Designation for Oral Paclitaxel for the treatment of angiosarcoma. In addition, in October 2019, the Company received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.

The Orascovery platform, based on P-gp pump inhibition technology, was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.