MD Anderson, BMS tout successes of researcher-led clinical trial model

MD Anderson Cancer Center
MD Anderson's researcher-led collaboration with Bristol-Myers Squibb included the first triplet immunotherapy combination study and changes in the standard of care for CML. (MD Anderson Cancer Center)

MD Anderson Cancer Center detailed the successes of their collaborative clinical research model launched in 2014, which directly connects academic experts to big pharma studies through a leukemia pilot program allowing for multiple, simultaneous immunotherapy studies.

By partnering with Bristol-Myers Squibb, MD Anderson leukemia researchers were able to explore BMS’ immuno-oncology pipeline across multiple blood malignancies. The resulting clinical trials included the first triplet immunotherapy combination study for leukemia, as well as in other treatments for several leukemia types. 

The proposed model places tumor‐specific researchers as the primary drivers of protocol design and implementation, with the potential to lower overall costs, improve success rates and hasten development timelines.

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MD Anderson’s collaboration with BMS has already led to a new standard of care for chronic myeloid leukemia, using an altered dose of dasatinib that makes the chemotherapy more effective and less toxic, according to the center. In addition, the partnership included a set level of funding for all research trials, eliminating the need to negotiate on a trial-by-trial basis.

The alternative research process was outlined in a review of today’s clinical cancer research, including its six decades of evolution from academic-based to industry-based, and the rise of contract research organizations. The review was published in the journal Cancer.

“This cancer research model is flexible and modifiable according to existing needs because it does not pretend to create a ‘one-size-fits-all’ approach,” said MD Anderson’s leukemia chair, Hagop Kantarjian, who co-authored the review.

“These types of alliances have significant variations that accommodate the partnering drug company—its drug pipeline, research needs, financial benefits and other considerations,” Kantarjian said.

RELATED: Bristol-Myers Squibb and MD Anderson Cancer Center Announce Novel Research Collaboration in Immuno-Oncology Focused on Leukemia and Hematologic Malignancies

Current methods can limit patient access and slow down development, MD Anderson said. CROs are typically outside groups and can have limited input from academic experts, focusing on a one-drug, one-cancer approach that may exclude higher-risk patients from trials through stricter eligibility criteria.

The new model can also allow researchers faster access to the study results. In the collaboration, results for all trials were analyzed by MD Anderson’s immunotherapy researchers.

“The success of this initiative has resulted in program expansion in a number of directions,” said co-author Ferran Prat, MD Anderson’s senior VP for research administration and industry ventures. 

“BMS extended the program to other clinical and research departments at MD Anderson, and is partnering with other academic cancer treatment institutions,” Prat said. “Our leukemia department and other MD Anderson programs have also established similar alliances with leading drug industry partners.”