Key Takeaways from ASH 2022: Real-World Data Gets Down to Business

Each year, the American Society of Hematology (ASH) brings together hundreds of researchers, clinicians, life science companies, and technology partners to share the latest breakthroughs in hematological care.

This year, experts descended on New Orleans to catch up on scientific progress and enjoy being in-person with their peers again after several years of enforced social distancing.

The COTA team was excited to be on site and take part in all the action. In addition to attending educational sessions and meeting with partners from the clinical and life sciences communities, COTA was proud to have several abstracts accepted for poster presentations at the conference.

We contributed directly to three posters showcasing the power of real-world data (RWD) in cancer research and supplied data to support four other important projects.  

After days of fascinating discussion, we took a moment to reflect on the major themes of the annual meeting – and not surprisingly, RWD was the thread that tied them all together.

No more explaining. It’s time to get work done.

Just a handful of years ago, we were still opening conversations with our elevator pitch defining RWD and explaining what we do with it. Now, we can skip the spiel and get right down to business.

RWD has quickly become an important part of the toolkit for therapeutic development and clinical research.  We’re not trying to figure out what it is anymore. Instead, we’re actively working together to solve the problems of accessing, curating, and applying these critical data assets to the thorniest problems of hematological care – and we’re making excellent progress on doing so.

It might not seem notable that RWD is no longer such a big deal, but it’s actually an important milestone. Now that stakeholders largely understand and embrace the potential of RWD to augment and expand our existing knowledge-generation systems, we can really get things done.

Generating new insights into comparative research

RWD is making it possible to answer unique questions about the comparative effectiveness of different therapies for blood cancers. As treatment patterns evolve, we need more insight into how different types of therapies compare to one another. RWD is helping to perform that research faster and with more diverse patient cohorts.

For example, there was a great deal of interest among ASH attendees in emerging research around chronic lymphocytic leukemia (CLL), the most common form of leukemia in adults. Not to blow our own horn, but we were delighted to see one of our posters become a focal point for the conversation.

Using real-world data, researchers from COTA and the University of Rochester were able to compare the outcomes of patients treated with Bruton tyrosine kinase inhibitors (BTKi) and B-cell lymphoma 2 (BCL2) therapy.

Although there were limitations to the research, the team found that progression-free survival and overall survival were slightly greater in patients receiving BCL2 therapies, adding important evidence to the discussion around the most suitable care pathways for similar patients.

Defining the role of regulators in the RWD environment

RWD may be fairly firmly established as a crucial component of clinical research, but the practical guardrails for its use are less well-developed. Regulators like the FDA and EMA are still working on guidance for using RWD in regulatory submissions and post-market surveillance, and industry stakeholders are keenly interested in how those efforts are going to play out.

It was a popular topic of conversation throughout the conference, and stakeholders were eager to swap theories about what’s going to happen next.  

The general consensus was that the industry is appreciative of the FDA’s recent draft guidance, but that finalized documents – and more specific details related to common use cases – would be extremely helpful. Industry stakeholders truly desire open collaboration on this matter, and it’s clear from the FDA’s willingness to participate in RWD research and share guidance that the regulator wants exactly the same thing.

Collaboration is likely to be the overarching theme bridging this year’s ASH and next year’s annual meeting. It’s essential for all members of the care and research communities to come together and share their challenges, opportunities, and successes so that we can all learn from one another.

COTA is proud to be part of the conversation and to contribute our knowledge about RWD to the ongoing development of more and more effective therapies for blood cancers and other oncological conditions. We’re looking forward to seeing what breakthroughs are in store for patients at ASH 2023!