Written by:
Adam Callahan, MS, MBA, VP
Gonzalo Rubio, MD, Medical Director
Why Immunotherapy Combinations Demand New Thinking
The past decade has seen immunotherapy shift from a promising innovation to a core pillar of cancer treatment. What began with checkpoint inhibitors has now expanded into a crowded pipeline of biologics, antibody-drug conjugates, cell therapies, and precision medicine strategies. This wave of progress brings both opportunity and challenge for biopharma innovators seeking to bring new therapies to market.
Rising Complexity and Costs
Developing an oncology therapy today can cost anywhere from $161 million to over $4.5 billion. At the same time, regulatory agencies are requiring greater clarity on how each component of a combination contributes to a patients’ overall outcome. This raises the stakes for biopharma innovators. It is no longer enough to show that a combination or targeted therapy works. Why it works, and how risks such as toxicity are managed become interwoven to the development, regulatory, and commercialization strategies.
Also, the financial and operational pressures mean that biopharma innovators must be intentional about evidence strategies, design of their clinical development plan, and the partners they select.
What’s Driving Change
Several forces are reshaping the landscape:
- Precision medicine is redefining patient selection, ensuring therapies reach the right populations.
- Immunotherapy combinations are expanding treatment options, moving into earlier lines of therapy and more complex indications.
- Advanced technologies like artificial intelligence and machine learning make it possible to analyze larger, complex data sets, improve trial efficiency, and manage costs.
- Flexible trial models that incorporate novel or adaptive trial designs, and prioritize patient safety while capitalizing on early signal detection to shorten timelines.
These shifts demand a new mindset from executives leading oncology programs—one that balances innovation with regulatory, operational, and economic realities.
Why It Matters for Executives
The opportunity in oncology has never been greater but so has the level of complexity Leaders must decide how to invest in new therapies and which CRO partners can provide both strategic guidance and global operational delivery excellence.
Getting these decisions right, early in development, can determine whether a therapy advances successfully or stalls under the weight of limited subject matter expertise, increasing costs, regulatory demands, and trial inefficiencies.
Watch the Full Discussion
In this recent webinar, we explore these trends in depth. From novel immunotherapy combinations and precision medicine strategies to advanced technologies and novel trial designs that are transforming trial execution. This session offers executives practical insight into current trends and strategic design considerations to support incremental evidence generation and commercial launch strategy for oncology drug development programs.