Oral paclitaxel combined with Ramucirumab for second-line treatment of gastric cancer shows initial efficacy

Oral paclitaxel combined with Ramucirumab for second-line treatment of gastric cancer shows initial efficacy

January 24, 2018 Source: Sina Pharmaceutical

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On January 22, Athenex, a multinational pharmaceutical company that develops and commercializes innovative cancer therapies, announced that the first clinical dosing cohort study of Oraxol (oral paclitaxel) in combination with Lilly CYRAMZA® (ramucirumab) in the treatment of patients with chemotherapy-deficient gastric cancer has ended. .

Oraxol is a paclitaxel oral preparation developed by a combination of paclitaxel and HM30181A in cooperation with Hanmi Pharmaceutical Co., Ltd., HM30181A is a specific p-gp preparation discovered by Hanmi Pharmaceutical based on an oral drug discovery platform.

A phase 2 trial of previously completed gastric cancer treatment showed that Oraxol was used for second-line treatment of patients with gastric cancer, and an encouraging median overall survival of 10.7 months was obtained. In patients with advanced gastric cancer who have failed chemotherapy, if they do not receive second-line treatment, the overall survival expectancy is only 4.0 months.

Ramucirumab is used as a monotherapy or in combination with paclitaxel and is approved by the FDA for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (where these patients with gastric cancer are undergoing or have completed fluoropyrimidine and platinum-containing chemotherapy and progress) Therapeutic drugs. The drug is produced and sold by Eli Lilly and Company. Athenex collaborated with Lilly to evaluate the treatment of gastric cancer in Oraxol+ramucirumab.

In the first cohort of 6 patients, Oraxol was well tolerated with ramucirumab, and 1 patient with complete recovery had grade 4 neutropenia. No death or neurotoxicity was observed in the trial. Two patients showed partial remission (tumor shrinkage 34-42%), three patients showed stable disease (one of them had a tumor shrinkage of 27%), and only one patient developed disease. Although an early study, these results are encouraging compared to the results of the previous phase 3 trials of paclitaxel injections and ramucirumab. Athenex is advancing the second cohort of Oraxol extended dose studies.

Dr. Rudolf Kwan, Athenex Chief Medical Officer, commented: "We are pleased to see that Oraxol and ramucirumab have shown good tolerance and encouraging in our first clinical trial of failed gastric cancer cohort studies. Tumor remission. We are working on a second cohort of patients taking higher doses of Oraxol to explore the possibility of a higher dose of clinical efficacy."

Oraxol is an innovative treatment for cancer treatment and is an oral dosage form of paclitaxel, an effective chemotherapy drug. The paclitaxel preparations currently marketed are administered intravenously. Paclitaxel alone cannot be absorbed orally because the drug is excreted by the gastrointestinal tract cells by a P-glycoprotein (P-gp) pump before being absorbed. By combining the P-gp inhibitor HM30181A, Oraxol has the potential for oral administration.

In addition to Oraxol, Athenex's oral discovery platform line also includes Oratecan (oral irinotecan), Oradoxel (oral docetaxel), Oratopo (oral topotecan). (Sina Pharmaceutical Compilation / David)

Article References: Athenex Announces Encouraging Results of the First Cohort of Phase I Clinical Trial of Oraxol and CYRAMZA® (Ramucirumab) Combination Treatment in Gastric Cancer

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