Merck launches Oncology Collaborative Trials Network

Jun 4 2010

Today, Merck announced the launch of the Merck Oncology Collaborative Trials Network, a pioneering clinical trial network focusing on the development of Merck drug and vaccine candidates being investigated for the treatment and prevention of cancer. The global network comprises leading cancer research centers who will partner with Merck to speed the development of innovative treatments for a range of cancers.

“A Phase I trial of the selective AKT inhibitor MK-2206 evaluating alternate daily and once-weekly doses in advanced cancer patients with evidence of target modulation and antitumor activity.”

Cancer is a diverse group of diseases that accounts for 7.4 million deaths (around 13 per cent of all deaths) worldwide every year, making it a leading cause of death globally. According to a recent Institute of Medicine report, about half of collaborative cancer studies are never completed due to cumbersome procedures, bureaucracy and poor coordination. The report suggested that collaborative research approaches could be improved by reducing the number of sites, properly funding research efforts, setting strict deadlines and prioritizing studies based on potential. The Merck Oncology Collaborative Trials Network embodies many of these principles.

"Despite recent advances, there remains an urgent need for effective treatments for cancer, and the pace of traditional drug development often lags far behind the latest science," said Malcolm Moore M.D., head of Medical and Hematological Oncology at Princess Margaret Hospital and a scientist at the Ontario Cancer Institute. "We are proud to participate in this unique network, which will create the access and the infrastructure for coordinated investigation of the latest clinical hypotheses in cancer research. The Merck Oncology Collaborative Trials Network could serve as a blueprint for how industry and research institutions can work together more efficiently and effectively to expedite the delivery of innovative cancer therapies to patients."

Through a rigorous proposal and feedback process, the research sites will lead the design and conduct of Phase 0 to 2a clinical studies of Merck's investigational oncology candidates. Every year, the network will enroll approximately 1,200 patients in 30 to 40 clinical trials. These studies will include investigator and company sponsored trials. Infrastructure to consolidate data, specimen testing results, imaging testing results, and patient outcomes is being developed. This approach will lead to more informed, data-driven, and rapid decision making regarding the efficacy and safety profile of compounds and the utility of biomarkers developed by Merck or its collaborators.

The network currently consists of 15 sites across North America, South America, Europe and Asia as follows:

Brazil:

• National Cancer Institute of Brazil (INCA), Rio de Janeiro
• Instituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de São Paulo, São Paulo

Canada:

• Princess Margaret Hospital and Ontario Cancer Institute, Toronto

France:

• Institut Gustave Roussy, Villejuif

Israel:

• Chaim Sheba Medical Center, Tel Hashomer

Korea:

• Seoul National University Hospital, Seoul
• Yonsei Cancer Center, Severance Hospital, Yonsei University Health System, Seoul

Netherlands:

• Netherlands Cancer Institute, Amsterdam

Norway:

• Oslo University Hospital, Oslo

Taiwan:

• National Taiwan University Hospital, Taipei

United States of America:

• Mayo Clinic Cancer Center, Rochester, MN, Scottsdale, AZ, Jacksonville, FL
• The University of Texas MD Anderson Cancer Center, Houston, TX
• Memorial Sloan Kettering Cancer Center, New York City, NY
• START Clinic, San Antonio, TX
• University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, San Francisco, CA

"Merck has strengthened its commitment to accelerating drug and vaccine development for people with cancer, and this unique network is a cornerstone of our strategy," said Gary Gilliland M.D., senior vice president of Merck Research Laboratories and Oncology Franchise Head. "By partnering at an early stage with global centers of excellence and combining our strengths in key areas such as biomarkers, information technology and adaptive clinical trial design, we are fundamentally changing the way we evaluate and advance our oncology pipeline."

Clinical Data on Oncology Pipeline Candidates at 2010 ASCO

Merck & Co., Inc. also announced that new early-stage clinical data on several investigational cancer agents will be featured at this year's American Society of Clinical Oncology (ASCO) annual meeting in Chicago. These candidates are part of Merck's growing oncology pipeline, which includes small molecules, biologics and therapeutic vaccine candidates targeting multiple biological pathways involved in the development and progression of cancer.

Among the early-stage studies being presented are three oral presentations:

• "A Phase I study of the oral mTOR inhibitor ridaforolimus in combination with the insulin-like growth factor 1 (IGF-1) receptor antibody dalotuzumab in patients with advanced solid tumors." (Abstract #3008)
• "A first-in-man trial of poly (ADP)-ribose polymerase (PARP) inhibitor MK-4827 in advanced cancer patients with anti-tumor activity in BRCA-deficient and sporadic ovarian cancers." (Abstract #3001)
• "A Phase I trial of the selective AKT inhibitor MK-2206 evaluating alternate daily and once-weekly doses in advanced cancer patients with evidence of target modulation and antitumor activity." (Abstract #3009)

Merck's Commitment to Oncology

Merck is committed to advancing all aspects of cancer care - prevention, treatment and supportive care. Through strong internal research capabilities, selective alliances and acquisitions, and enabling technologies, Merck is looking to lead in the discovery, development and delivery of targeted anticancer therapies.

Today's Merck is developing candidates that target key pathways and processes involved in the growth and progression of cancer, including PI3 kinase and other signaling pathways; DNA damage repair, cell-cycle and checkpoint pathways; and developmental pathways. Merck is also pursuing novel cancer vaccines.

Merck's expanded commitment to oncology builds on a strong portfolio of medicines and a diverse pipeline of investigational agents. In addition, Merck is committed to helping ensure eligible patients have access to our medicines.

Source Merck