On November 26, 2018 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 that it has initiated a Phase I/II clinical study to assess the safety, tolerability and activity of Oraxol in combination with an anti-PD1 antibody (pembrolizumab) in patients with advanced solid malignancies, in collaboration with Mayo Clinic (Press release, Athenex, NOV 26, 2018, View Source;p=RssLanding&cat=news&id=2378119 [SID1234531608]).
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!
Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Pembrolizumab is a checkpoint inhibitor approved by the United States Food and Drug Administration (FDA).
The study (KX-ORAX-011) is a Phase I/II study being conducted in patients with urothelial, gastric/gastroesophageal or non-small cell lung cancer that have previously failed treatment with a checkpoint inhibitor. The primary outcome measures are tumor response rate and determination of maximum tolerated dose, while the secondary outcome measures include progression free survival, overall survival, duration of response and pharmacokinetics.
Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "Oraxol has an excellent pharmacokinetic profile. Early studies showed that Oraxol, given without concomitant steroids, has the potential to offer a better efficacy and safety profile when compared with traditional intravenous paclitaxel. We are excited to test the hypothesis that a combination of Oraxol with checkpoint inhibitors will achieve a good efficacy and safety profile in patients who have already failed prior checkpoint inhibitor treatment."
Dr. Johnson Lau, Chief Executive Officer of Athenex, stated, "The recent approval by the FDA of an anti-PD1 drug in combination with carboplatin and paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer serves as recognition of the synergy of immunotherapy in combination with chemotherapeutic drugs. We believe that Oraxol may be an excellent choice in combination with cancer immunotherapy and success in this study could be a major milestone, reinforcing the Company’s commitment to delivering safe and effective innovative therapies to cancer patients."
For more information about the study, please visit View Source;rank=7.
Oraxol is currently also being tested in combination with ramucirumab (an anti-VEGF-R2 monoclonal antibody) in a Phase I/II study in patients with gastric cancer. Athenex reported earlier in the year the encouraging results in the first cohort of patients.
The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi