Sunday, July 21, 2013

Kyowa Hakko Kirin seeks MHLW Approval for Additional Indication for ATL, PTCL and CTCL of Mogamulizumab

Kyowa Hakko Kirin Co., Ltd. has been filed an application to Japan's Ministry of Health, Labour and Welfare ("MHLW") seeking approval for additional indication for untreated CCR4-positive adult T-cell leukemia-lymphoma (ATL), relapsed CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO® Injection 20 mg).

Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including ATL, PTCL and CTCL cells. Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Clinical studies of Mogamulizumab in patients with untreated CCR4-positive ATL, relapsed CCR4-positive PTCL and CTCL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to file an application. Mogamulizumab was also granted orphan drug designations for the treatment of CCR4-positive ATL in August 2010, PTCL and CTCL in March 2013 by the MHLW.
Mogamulizumab was launched in Japan with the brand name "POTELIGIO® Injection 20 mg" on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.


Overview of Phase II Clinical Study for untreated ATL in Japan
ObjectiveEvaluate the efficacy, safety and pharmacokinetics of mLSG15 + Mogamulizumab or mLSG15 in patients with untreated CCR4-positive ATL.
Mogamulizumab: 1.0 mg/kg/2wks for eight times in patients
Primary EndpointEfficacy (complete response rate, ORR), safety, pharmacokinetics
EfficacyEfficacy was assessed in 53 patients
(mLSG15 + Mogamulizumab: 29 patients, mLSG15: 24 patients)
[Complete response rate]
mLSG15 + Mogamulizumab: 52% (95%CI; 33-71%)(15/29)
mLSG15: 33% (95%CI; 16-55%)(8/24)
[ORR]
mLSG15 + Mogamulizumab: 86% (95%CI; 68-96%)(25/29)
mLSG15: 75% (95%CI; 53-90%)(18/24)
Add-on effects of Mogamulizumab were found on mLSG15 therapy in complete response rate and ORR
SafetySafety was assessed in 53 patients
Common adverse events might cause by mLSG15 therapy in patients, add-on therapy of Mogamulizumab was found to be well tolerated at this dose level on mLSG15 therapy.
Overview of Phase II Clinical Study for PTCL and CTCL in Japan
ObjectiveEvaluate the efficacy, safety and pharmacokinetics of Mogamulizumab at 1.0 mg/kg weekly for eight weeks in patients with CCR4-positive relapsed PTCL and CTCL.
Primary EndpointEfficacy (ORR), safety, pharmacokinetics
EfficacyEfficacy was assessed in 37 patients
(PTCL: 29 patients, CTCL: 8 patients)
[ORR]
35% (95% CI; 20-53%)(13/37)
(complete response in 5 patients, partial response in 8 patients)
[ORR for PTCL]
34% (95% CI; 18-54%)(10/29)
(complete response in 5 patients, partial response in 5 patients)
[ORR for CTCL]
38% (95% CI; 9-76%)(3/8)
(partial response in 3 patients)
SafetySafety was assessed in 37 patients Mogamulizumab was found to be well tolerated at this dose level.


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