June 4th, 2012
ONO PHARMACEUTICAL
CO., LTD. Corporate
Communications Phone: +81-6-6263-5670
Fully Human Anti-PD-1 Antibody "ONO-4538/BMS-936558"
Results from Phase 1 Study in Cancer Patients Published in
New England Journal of Medicine
(NEJM) and Presented at Annual Meeting of the American
Society of Clinical Oncology (ASCO)
Bristol-Myers Squibb Company (hereinafter referred to as
"BMS") announced the results from Phase 1 study in patients
with non-small-cell lung cancer (NSCLC), metastatic melanoma
and renal cell carcinoma (RCC) to be published in New England
Journal of Medicine (NEJM) and presented at 48th
Annual Meeting of the American Society of Clinical Oncology
(ASCO), on June 2nd (US time).
ONO-4538/BMS-936558, a fully human anti-PD-1 antibody, is an
investigational cancer immunotherapy generated under a
research collaboration entered into in May 2005 between Ono
Pharmaceutical Co., Ltd. (hereinafter referred to as "Ono")
and Medarex, Inc. When Medarex, Inc. was acquired by BMS in
2009, it also granted BMS its rights to develop and
commercialize the anti-PD-1 antibody in North America.
Through the collaboration agreement entered into in September
2011 between Ono and BMS, Ono granted BMS exclusive rights to
develop and commercialize ONO-4538/BMS-936558 in the rest of
the world, except in Japan, Korea and Taiwan where Ono has
retained all rights to develop and commercialize the
compound.
BMS is conducting a Phase 2 study in RCC in North America and
Europe, and plans to initiate registrational studies for
anti-PD-1 this year in NSCLC and RCC, and late 2012, early
2013 for metastatic melanoma. On the other hand, Ono is
conducting a Phase 2 study in metastatic melanoma in Japan,
and plans to initiate clinical studies in RCC and NSCLC,
taking account of the development status in United States and
Europe.
Attached from the following page is the press release made by
BMS for your information.
Investigational Anti-PD-1 Immunotherapy BMS-936558 Showed
Clinical Activity in Phase 1
Trial of Patients with Previously-Treated Non-Small-Cell Lung
Cancer, Metastatic Melanoma and Renal Cell Cancer
United Kingdom
France
Deutschland
Schweiz (DE)
