MMS Holdings (MMS), a global, data-focused clinical research organisation (CRO), has been selected by Friends of Cancer Research (Friends), a leading nonprofit dedicated to accelerating innovation in cancer research, to support the development of practical decision frameworks to inform the interpretation of interim overall survival (OS) data in oncology clinical trials.

The collaboration addresses a longstanding challenge in cancer drug development: how to assess long-term treatment benefit when OS data remain immature. In many oncology studies, developers use endpoints such as progression-free survival (PFS) and objective response rate (ORR) as an initial indicator of treatment efficacy. However, evaluating OS data at the same interim point can complicate the assessment of long-term benefit or harm. To provide clarity, Friends has convened a consortium of stakeholders to develop and evaluate different modeling scenarios, including crossover effects and delayed treatment benefits.

MMS will lead simulation and modeling efforts for this project based on both its simulation platform, KerusCloud, and its deep bench of regulatory and statistical experts.

KerusCloud enables realistic modeling of oncology endpoints and allows stakeholders to explore different scenarios and decision thresholds, providing a clear view of the potential risks and benefits associated with acting on immature data in oncology clinical trials, and supporting more informed decisions earlier in the trial process.

Commenting on the partnership, Jeff Allen, President and CEO, Friends of Cancer Research, said, “As timely access to innovative cancer therapies remains a key factor for patients, this initiative represents an important step toward optimal acceleration.”  

“We are excited to partner with MMS along with the consortium who bring a combination of statistical depth, real-world understanding of oncology trial design, and powerful simulation tools to help tackle these challenges,” he added.

Expressing gratitude for the collaboration, MMS CEO Uma Sharma said, “Having supported several key oncology approvals, we are uniquely positioned to help model the right questions and deliver practical frameworks that will shape future regulatory guidance and support better decision-making across the field.”

Aiden Flynn, Sr. VP Strategic Statistical Consulting at MMS, added, “By combining our regulatory insight with advanced simulation capabilities, we are helping develop practical tools and decision frameworks that give developers greater confidence to act on early data, and ultimately improve access for patients.”

The initiative aims to deliver practical guidance and a simulation toolbox that can be shared broadly across the oncology community, helping stakeholders better anticipate the implications of interim OS data on regulatory decisions.