Abstract 210P
Background
Perioperative chemoimmunotherapy has become the standard of care for resectable, locally advanced non-small cell lung cancer (NSCLC). Pathological complete response (pCR) is emerging as an early endpoint correlating with over 95% five-year overall survival (OS). Minimal residual disease (MRD), assessed via circulating tumor DNA (ctDNA), could offer improved risk-stratification. Here, we evaluate the prognostic value of MRD in the NADIM II trial (NCT03838159).
Methods
Patients with resectable NSCLC and no known EGFR/ALK alterations were randomized to receive neoadjuvant nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection. Patients, in experimental arm, with R0 resection initiated adjuvant nivolumab. MRD was measured in 58 plasma samples collected after surgery and during adjuvant treatment in 21 cases, using Guardant Reveal, a tissue-free epigenomic assay intended for detection and quantification of ctDNA. Event-free survival (EFS) and OS analysis was performed considering only cancer-related events.
Results
MRD detection after surgery or during adjuvant treatment was associated with inferior EFS and OS (HR: 10.2; 95%CI: 3.7–28.3 and HR: 10; 95%CI: 2.0–49.9, respectively). All patients with MRD-negative plasma samples at both time points were alive (HR: NE, P < 0.001), with only one relapse (HR: 41.6; 95% CI: 5.0–348.8). MRD assessment significantly enhanced the prognostic value of pCR for EFS (P < 0.001) and OS (P=0.015). Among non-pCR patients, MRD measured postsurgery or during adjuvant therapy remained a significant prognostic marker (HR: 6.2; 95%CI: 2.2–17.1 and HR: 6.5; 95%CI: 1.3–32.5, for EFS and OS respectively). All non-pCR patients with MRD-negative results at both time points were alive (HR: NE, P=0.025), with only one relapse (HR: 19.8; 95% CI: 2.4–165.6).
Conclusions
MRD significantly enhances the prognostic value pCR, being a valuable tool for monitoring adjuvant therapy. Clinical trial identification: NCT03838159.
Legal entity responsible for the study
Fundacion GECP.
Funding
BMS.
Disclosure
All authors have declared no conflicts of interest.