3 key takeaways from ASCO 2025: Staying nimble in a changing environment
The annual meeting of the American Society of Clinical Oncology (ASCO) is a chance for oncology professionals, patient advocates, data experts, and industry representatives to come together and share the latest research in cancer care. This year, thousands of attendees descended on Chicago to attend educational sessions, view research posters, collaborate in workshops, and strengthen connections with colleagues across five days of non-stop learning. For members of the COTA team, it’s also an opportunity to keep our finger on the pulse of a rapidly evolving industry: one that is highly sensitive to shifts in regulatory, economic, and scientific circumstances.
As we reflect on a conference packed with fruitful conversations and edifying events, a few major themes stand out. Here are our top 3 takeaways from ASCO 2025.
Pharma companies are focused on reducing risk and prioritizing flexibility
Pharma companies are actively working on moving away from the traditional “ten years and a billion dollars” approach to drug development. To do so, they are exploring new ways to take the risks out of the process, whether through using real-world data (RWD) and artificial intelligence to better pinpoint promising avenues or working more closely with regulatory bodies earlier in the process of trial design to prevent avoidable back-and-forth later in the game. Drug developers are also searching for better ways to make the most of their existing investments by expanding indications in a safe and effective manner. Companies are showing strong interest in new techniques to scale up indications quickly to cover more conditions without reinventing the wheel.
The ability to leverage robust, representative, and accurate RWD will be essential for understanding how to best position approved therapies for expanded indications and maximize the potential for better patient outcomes.
The industry is keeping a cautious eye on FDA changes
Regulatory uncertainty was a much-discussed topic at ASCO this year. The FDA is undergoing significant internal changes, which could affect the approvals process for new oncology therapies. Fortunately, industry insiders are not seeing negative consequences from the activity just yet, with many reporting that FDA responses to pending approvals applications are still coming back on time.
There is a sense of restrained optimism that cancer approvals won’t be too badly affected by the stressors affecting the FDA in general, so companies are still moving ahead with their plans to move potential products through the regulatory pipeline.
A push to close gaps in traditional data sources
The race to innovate with as little risk as possible means that pharma companies are looking for proven ways to expand and augment their standard process with data that can help them get ahead. As a result, RWD is becoming increasingly embedded in the drug development process due to its ability to close gaps in traditional data sources and enhance visibility into net-new areas of discovery. Major companies are exploring a variety of projects with an RWD component, from better understanding why and how certain guidelines are being followed in real-world practice to improving their ability to trace adverse events and deliver optimal outcomes.
The companies that can harness RWD’s potential quickly and effectively are going to be best positioned for success in the highly competitive world of oncology therapies, so it’s no wonder that RWD featured prominently in many poster presentations and educational sessions across many different areas of cancer research.
Overall, the mood at ASCO 2025 was enthusiastic and resolute, with a return to pre-pandemic energy and attendance levels. We’re eager to see how the oncology community continues to build on the knowledge shared during this event throughout the year. Now on to EHA where COTA data is powering nine accepted abstracts in Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, and Multiple Myeloma.
