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.

Abstract

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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