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December 7, 2010

Kyowa Hakko Kirin Announces Results from Japan Phase 2 Clinical Trial of
KW-0761 (Anti-CCR4 Humanized Monoclonal Antibody) in Patients with
Recurrent or Relapsed Adult T-Cell Leukemia-Lymphoma (ATL)

Kyowa Hakko Kirin Co., Ltd. (Tokyo Japan; President and CEO: Yuzuru Matsuda; hereinafter referred to as “Kyowa Hakko Kirin”) announced that results from a Phase 2 clinical trial of its KW-0761 conducted in Japan were presented at the 52nd American Society of Hematology (ASH) Annual Meeting held from December 4 to 7, 2010 in Orlando, Florida, United States.

KW-0761 is an anti-CCR4 humanized monoclonal antibody created using POTELLIGENT®, a technology developed exclusively by Kyowa Hakko Kirin to produce enhanced antibody activity. KW-0761 recognizes CCR4 as an antigen and depletes target cells through Antibody-Dependent Cellular Cytotoxicity (ADCC) activity.

The presentation (abstract number: 285) pertained to a multicenter Phase 2 clinical trial in patients with adult T-cell leukemia-lymphoma (ATL) that has recurred or relapsed after completion of chemotherapy. It was delivered orally by Dr. Takashi Ishida from the Medical Oncology & Immunology, Nagoya City University. This clinical trial was designed to evaluate the efficacy and safety of KW-0761 administered at 1.0 mg/kg weekly for eight weeks in 27 patients. Adverse events frequently noted in the patients were hematotoxicity such as decreases in lymphocyte counts, neutrophil counts and platelet counts, and non-hematotoxicity such as acute infusion reaction, rash and elevated liver enzymes. However, these adverse events can be properly managed by supportive cares, and therefore, KW-0761 was found to be tolerated at this dose level. As for the efficacy, the overall response rate as the primary endpoint was 50% (95% CI; 30 – 70%), which validated the efficacy of KW-0761 against recurrent or relapsed CCR4-positive ATL.

There are other ongoing clinical trials of KW-0761 conducted in Japan: a Phase 2 clinical trial of mLSG15 therapý combined with KW-0761 in patients with newly diagnosed, untreated CCR4-positive ATL; and a Phase 2 clinical trial in patients with CCR4-positive peripheral T/NK-cell lymphoma that has recurred or relapsed after completion of chemotherapy.

Kyowa Hakko Kirin places its focus on the field of cancer with antibody engineering technologies at its core. The company aims to continuously create revolutionary new medicines to contribute to improving cancer treatment and QOL of cancer patients.

< The following shows the overview of Japan Phase 2 clinical trial presented at the ASH >

1. Summary of the study

Study objective To evaluate the efficacy and safety of KW-0761 administered at 1.0 mg/kg weekly for eight weeks in patients with CCR4-positive adult T-cell leukemia-lymphoma (ATL) that has recurred or relapsed after completion of chemotherapy.
Target patient
enrollment
25 patients
Primary endpoint Efficacy (overall response rate, etc.) and safety

2. Outlines of the main data presented at the ASH

Efficacy Efficacy was assessed in 26 patients.
Overall response rate: 50% (95% CI; 30 – 70%) Breakdown: 8 patients in complete response and 5 patients in partial response
Progression-free survival: a median survival of about 5 months
Safety Safety was assessed in 27 patients.
Hematotoxicity: decreased lymphocyte counts (26), decreased white blood cell counts (18), decreased platelet counts (14) and decreased neutrophil counts (14) Non-hematotoxicity: acute infusion reaction (24), rash (17), elevated ALT (11), elevated AST (10) and hypoxemia (5)


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