Clinical Development of Novel-Novel Multi-Company Combination Therapies in Oncology
Patrick Y Muller1, Johannes Eisinger2, Pakeeza Sayyed3
1Bristol-Myers Squibb, Hematology Clinical Development, Boudry, Switzerland. patrick.mueller@bms.com.
Purpose Of Review:
Most novel anti-cancer therapies involve combining multiple immuno-oncology and/or targeted drugs. The historical paradigm of exploring combination regimens only after approval of the individual drugs is changing rapidly leading to clinical development of 'novel-novel' combination therapies consisting of at least two investigational agents.
Recent Findings:
Initiating those combination efforts early in development is an important strategy to accelerate evolution of the standard of care for high unmet need cancer indications. However, there are specific challenges associated with such development programs, with additional complexity if more than one company is involved. Representing a consortium of major oncology drug developers, we critically discuss those challenges and suggest potential solutions to encourage the development of novel multi-company combination therapies for solid and hematological tumors. The areas covered include trial strategies for early and late clinical development, including dose/regimen optimization, statistical considerations, optimizing safety profiles, dose modification approaches, contribution of components, choice of standard of care backbone and comparator regimens as well as regulatory strategies.
Insights
Developing novel combination cancer therapies early is crucial. This review addresses challenges and solutions for multi-company investigational drug combinations in oncology.
Area of Science:
- Oncology
- Clinical Trial Design
- Drug Development
Background:
- Novel anti-cancer therapies increasingly combine immuno-oncology and targeted drugs.
- The trend is shifting towards developing novel combination therapies with multiple investigational agents early in the process.
Purpose of the Study:
- To discuss the challenges and propose solutions for developing novel combination therapies involving multiple investigational agents, particularly when multiple companies are involved.
- To accelerate the evolution of the standard of care for cancers with high unmet needs.
Main Methods:
- Critical discussion of challenges based on a consortium of major oncology drug developers.
- Exploration of strategies for early and late clinical development of combination therapies.
Main Results:
- Identified key challenges in developing novel multi-company combination therapies.
- Suggested potential solutions and strategies for trial design, safety, and regulatory aspects.
Conclusions:
- Early development of novel combination therapies is essential for advancing cancer care.
- Addressing challenges in multi-company collaborations is key to successfully bringing these therapies to patients with solid and hematological tumors.
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