Last week at the 2023 ASCO Annual Meeting, Friends presented new results from several projects: ctMoniTR Step 2, rw-Response, and the ASCO-Friends project. Here are some key takeaways from those presentations and why these results matter:

Changes in ctDNA levels as an early indicator of outcomes in advanced NSCLC treated with TKI: Initial findings from a retrospective aggregate analysis of 8 clinical trials

Circulating tumor DNA (ctDNA) shows promise as an early endpoint to support drug development and regulatory decision-making. Friends aggregated data from 8 clinical trials in patients with advanced non-small cell lung cancer (aNSCLC) treated with tyrosine kinase inhibitors (TKIs) to understand the relationship between changes in ctDNA levels and clinical outcomes. The analysis showed that when ctDNA was not detected within the first 10-weeks of treatment, patients had the best outcomes (i.e., progression-free and overall survival) compared to when ctDNA was detected during the same time frame. These findings suggest ctDNA may be able to be used to assess response to treatment in patients treated with TKIs as early as 10-weeks after start of therapy. Read the ASCO abstract here and register for Friends’ ctDNA meeting on July 11 to learn more here.

Real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets

Clinical trials often measure response to treatment, such as evaluating a reduction in tumor size using imaging, as an early indication of treatment activity. While measurement of response in clinical trials is often based on the evaluation of radiographic images at prespecified time points, in real-world clinical practice there may be variation in when and how response is evaluated and reported. To build on previous work in our real-world evidence (RWE) portfolio which aims to support use of real-world data (RWD) for regulatory decision-making, Friends convened stakeholders and conducted an analysis across seven electronic health record (EHR) data aggregators to assess the availability of data components that measure real-world response rate (rwRR) and evaluated the consistency of the measure across sources. The analysis showed measurement of response was consistent across data sources and demonstrated the feasibility of measuring rwRR based on clinician assessments reported in the EHR. Future work to use RWD to measure response has the potential to inform the evaluation of drug effectiveness in real-world patient populations. Read the ASCO abstract here and register for Friends’ RWE meeting on September 11 to learn more here.

Impact of COVID-19 pandemic mitigation strategies on industry and NCI cancer treatment trials

The COVID-19 pandemic disrupted enrollment and conduct of cancer treatment trials. As a result, regulators encouraged flexibility in trial processes to support continuity in clinical research and care. An analysis of surveys and interviews with pharmaceutical companies and National Cancer Institute (NCI) cooperative groups indicated wide adoption of mitigation strategies such as telemedicine and remote informed consent discussions. Despite adoption of flexibilities which were sometimes considered clinical trial protocol deviations pre-pandemic, survey and interview participants perceived minimal impact on trial data integrity. These results provide support for continued adoption of mitigation strategies in future clinical trials. Incorporating these flexibilities in future clinical trials can help to improve access to clinical trials for patients. Read the ASCO abstract here.