An increasing amount of clinical evidence has amassed in support of circulating tumor DNA (ctDNA) as a predictive biomarker for immunotherapy response.
Most notably, a Phase 2 study of metastatic solid tumor patients (Bratman et al., Nature Cancer 2020) demonstrated that ctDNA could predict response to pembrolizumab as early as after 2 cycles (approx. 6-7 weeks) of treatment. The latest data from the i-SPY 2 and BELLINI studies, presented at AACR 2022 and ESMO 2022 respectively, suggest that early clearance of ctDNA (after 3-4 weeks of IO) is also associated with treatment benefit in the neoadjuvant setting for breast cancer.
Additionally, stratification of patients by detection of molecular residual disease (MRD) as assessed by ctDNA is shown to predict adjuvant atezolizumab benefit in muscle-invasive bladder cancer, as compared to patients without detectable MRD (Powles et. al, Nature 2021). This analysis has subsequently led to the initiation of a registrational Phase 3 study that uses ctDNA-guided enrollment.
Finally, Medicare reimbursement is available for immunotherapy response monitoring by ctDNA in all approved solid tumor indications, enabling its use in clinical practice.
Watch this webinar and panel discussion on the ways in which ctDNA is changing immuno-oncology clinical trials and patient management, including:
- Latest data from clinical studies leveraging circulating tumor DNA (ctDNA) to select patients most likely to benefit from immunotherapy and to predict therapy response within weeks after beginning treatment
- Real-world patient case studies using immunotherapy response monitoring in clinical practice
- Opportunities to continue validating ctDNA as a predictive biomarker in patient stratification for clinical trials and identifying responders
- Future directions and path to realizing the potential of ctDNA in this setting