Athenex (ATNX) Reports Results from First Cohort of Phase I Clinical Trial of Oraxol and CYRAMZA Combination Treatment in Gastric Cancer

January 22, 2018 7:01 AM EST
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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, today announced the completion of the first cohort of patients in its Phase 1b clinical trial of Oraxol (oral paclitaxel) plus CYRAMZA® (ramucirumab) in gastric cancer patients that failed previous chemotherapies. Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel P-gp inhibitor).

A previously completed Phase II clinical trial of Oraxol in the second-line treatment of gastric cancer patients showed an encouraging overall median survival of 10.7 months. The expected overall survival for advanced gastric cancer patients who have failed previous chemotherapy and do not receive second-line therapy is approximately 4.0 months.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company. Athenex is evaluating the effect of Oraxol plus ramucirumab in gastric cancer in collaboration with Lilly.

Of the six patients in the first cohort, the Oraxol and ramucirumab combination treatment was well tolerated. Grade 4 neutropenia occurred in one patient who fully recovered and there were no patient deaths. There was no neuropathy. Two patients had partial responses (tumor shrinkage of 34-42%) and three patients had stable diseases (with tumor shrinkage of 27% in one patient). Only one patient had progressive disease. Although early, these results are regarded as encouraging compared with previous IV paclitaxel and ramucirumab combination therapy Phase III clinical trial results. Athenex is advancing to the second cohort with Oraxol dose escalation.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, “We are heartened to see Oraxol and ramucirumab is well-tolerated with encouraging tumor response in our first cohort of patients with gastric cancer that failed previous chemotherapies in this Phase I clinical trial. We are proceeding to the second cohort of patients with an escalation dose of Oraxol to explore the possibility of even better clinical efficacy with a higher dose.”

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex.

PharmaEssentia Corp., licensed the Taiwan rights to Oraxol from Athenex and is a partner in the development of Oraxol in Taiwan.

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