On May 3, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported preliminary data showing promising early clinical responses in the first part of a two part study of Oraxol (oral paclitaxel and encequidar, also known as HM30181A) monotherapy in patients with unresectable cutaneous angiosarcoma (Press release, Athenex, MAY 3, 2019, View Source;p=RssLanding&cat=news&id=2397066 [SID1234535700]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
To date, 10 patients have been enrolled in the clinical study, which is being conducted in four sites in the U.S. and Hong Kong. The first 7 patients have received at least six weeks of treatment, which is the timepoint for the first response assessment; 3 patients have not yet reached the first assessment timepoint. Oraxol is being administered once daily for three consecutive days every week during the treatment period.
All 7 patients showed significant and visible reduction of the cutaneous angiosarcoma within one or two weeks of treatment. Three patients had complete responses based on RECIST v1.1 criteria, with two complete responses occurring by 6 weeks of treatment.
Selected images showing early visible response in one week, from a patient with complete response (Patient A) are available at
Selected images showing a patient with complete response after 6 weeks of treatment (Patient B) are available at
None of the patients enrolled have discontinued treatment due to death, disease progression, or adverse events. No peripheral neuropathy has been reported.
Based on the preliminary data, the study has met the criteria required to proceed to full enrollment.
Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, "I am impressed by the rapid clinical response to Oraxol monotherapy treatment in this group of difficult-to-treat patients. The high response rate observed, including three patients who had early complete response, is consistent with the hypothesis that oral delivery of paclitaxel can potentially achieve a more desirable pharmacokinetic profile and a better clinical outcome. I believe the good tolerance of Oraxol in this older patient population would be welcome by both clinicians and patients. This may represent a paradigm shift in the treatment of patients with cutaneous angiosarcoma."
Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, commented, "The consistently high response rate observed in various clinical settings, including in the treatment of metastatic breast cancer, unresectable gastric cancer, and now cutaneous angiosarcoma, highlight the potential of Oraxol as an effective therapeutic for a broad range of cancers. With results showing high response rates, lack of significant neuropathy and oral convenience with no need for concomitant use of intravenous steroid pre-treatment, I believe Oraxol also has the potential to transform treatment regimens that use a high potency chemotherapeutic agent in combination with other newly developed anti-cancer therapeutics. We are already evaluating the combination of Oraxol with ramucirumab and Oraxol with an anti-PD1 (pembrolizumab) in clinical studies."
Oraxol (oral paclitaxel and encequidar, or HM30181A) was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of angiosarcomas in April 2018.
The clinical trial, designed and led by Principal Investigator Vinod Ravi, M.D., associate professor of Sarcoma Medical Oncology at The University of Texas MD Anderson Cancer Center, is open at MD Anderson in Houston, Fred Hutchinson Cancer Center in Seattle and Prince of Wales Hospital, Shatin, in Hong Kong. For more details about the clinical study, please visit ClinicalTrials.gov at View Source
Athenex is completing a Phase III clinical trial of Oraxol in the treatment of metastatic breast cancer. In April 2019, the company presented an abstract on preclinical data of oral paclitaxel and HM30181A (encequidar) in angiosarcoma at the American Association of Cancer Research Annual Meeting 2019 in Atlanta, Georgia. In December 2018, Athenex announced positive second cohort results of Oraxol-plus-ramucirumab Phase 1b clinical trial in gastric cancer (more details can be found here). In October 2018, Athenex presented encouraging clinical trial efficacy and safety results of Oraxol in the treatment of metastatic breast cancer in a Phase II clinical trial in Taiwan at ESMO (Free ESMO Whitepaper) 2018 (more details can be found here).
The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.
About Angiosarcoma
Angiosarcomas are a type of soft tissue sarcoma characterized by rapidly proliferating, extensively infiltrating, anaplastic cells derived from blood and lymphatic vessels. Angiosarcomas arise in various body sites, including cutaneous, soft tissue, and visceral locations. Angiosarcomas are frequently metastatic at diagnosis, with a natural history complicated by local recurrence, distant metastases, and poor overall survival. Angiosarcomas represent about 2% of soft tissue sarcomas and 5.4% of cutaneous soft tissue sarcomas.
There is no approved treatment for angiosarcoma and survival is limited with treatments currently available. However, reports in the literature of objective tumor response support the use of intravenous paclitaxel in the treatment of angiosarcoma.