Dr Raez on the Effect of the NADIM II Trial on the Neoadjuvant Treatment Paradigm in NSCLC

Luis E. Raez, MD, FACP, FCCP, hematology/oncology, medical director, chief scientific officer, Memorial Cancer Institute, Memorial Healthcare System, clinical professor of medicine, Florida International University, research professor, Florida Atlantic University, visiting professor of medicine, Cayetano Heredia University, Peru, discusses how findings from the phase 2 NADIM II trial (NCT03838159) inform the neoadjuvant treatment paradigm in non–small cell lung cancer (NSCLC).

Administration of neoadjuvant immunotherapy before surgery is still a fairly novel approach within lung cancer. This treatment approach is supported by data from the phase 3 CheckMate 816 trial (NCT02998528), which demonstrated the superiority and safety of neoadjuvant nivolumab (Opdivo) plus chemotherapy in resectable NSCLC, Raez says. Based on these data, the regimen gained FDA approval in 2022. However, the study did not involve the use of adjuvant immunotherapy, Raez notes. 

The open-label, randomized, multicenter NADIM II trial evaluated the addition of neoadjuvant nivolumab to platinum-based chemotherapy in patients with potentially resectable, stage IIIA to IIIB NSCLC and no known EGFR/ALK alterations, Raez states. Patients were randomly assigned to receive 3 cycles of neoadjuvant nivolumab plus paclitaxel and carboplatin followed by surgery, or chemotherapy followed by surgery. Notably, patients in the experimental arm were also given adjuvant nivolumab for 6 months following surgery, while patients in the control arm were under observation every 12 weeks for this period, Raez adds.

Updated survival data presented at the 2022 World Conference on Lung Cancer showed that patients given neoadjuvant nivolumab plus chemotherapy experienced significant overall survival (OS) benefit vs chemotherapy alone, Raez reports. The 24-month OS rate with the experimental regimen was 85.3%, and the pathologic complete response rate was 36.2%. These rates were 64.8% and 6.8% in the control arm. 

Overall, these findings confirm the utility of neoadjuvant immunotherapy-based regimens in resectable stage IIIA to IIIB NSCLC and indicate the value of adjuvant immunotherapy in this space.