On October 8, 2013 (Tokyo) – Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, "Chugai")] reported that it has filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW) on October 7, 2013, for ALK (Anaplastic Lymphoma Kinase) inhibitor "alectinib hydrochloride (Development code: AF802, Roche Development Code: RG7853, Compound number: CH5424802)" for the treatment of ALK fusion gene positive non-small cell lung cancer (NSCLC) (Press release, Chugai, OCT 8, 2013, View Source [SID1234500029]). On September 13, 2013, alectinib hydrochloride for the treatment of "ALK fusion gene positive unresectable, recurrent / advanced non-small cell lung cancer" was designated as orphan drug by MHLW.
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Chugai filed the application with the MHLW based on the results from a Japanese phase I/II clinical trial, before the phase III clinical trial results will be available. The clinical trial was conducted at 13 medical institutions in Japan in ALK fusion gene positive lung cancer patients with a treatment history of chemotherapy. The clinical trial was conducted in two phases; the phase 1 portion was conducted to evaluate safety and to determine the recommended dose (24 patients), and the phase 2 portion was conducted to evaluate the efficacy and safety of the confirmed recommended dose (46 patients).
As a result, the recommended dose was determined to be 300 mg twice daily in phase 1. Phase 2 was conducted using the recommended dose, and as a result, tumor regression was observed in 43 (93.5%) out of 46 patients. Regarding safety, there were no treatment-related deaths and grade 4 or higher serious adverse reactions assessed according to CTCAE (Common Terminology Criteria for Adverse Events) defined by the Japan Clinical Oncology Group. The most frequently observed grade 3 or higher adverse reactions were neutropenia and increase in creatine phosphokinase (CPK). The incidence of both adverse events was 2 (4.3%) out of 46 patients*.
Based on the results of an American Phase I dose-escalation study of patients with ALK fusion gene positive NSCLC whose disease had progressed on crizotinib therapy, in addition to Japanese Phase I/II clinical trial results, alectinib hydrochloride was found to meet the criteria for Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) on June 26, 2013. The results of the American study were presented as a late-breaker at the 2013 European Cancer Congress (ECC) in Amsterdam.
As the top pharmaceutical company in the field of oncology in Japan, Chugai will work for the approval to provide patients and medical professionals with new treatment options as soon as possible.
* Seto et al., Lancet Oncol. 14: 590-598 (2013)