Rami Manochakian, MD, on NSCLC: Clinical Implications of Findings on Nivolumab Plus Chemotherapy

The NADIM II Trial is a randomized open label Phase II trial of Neoadjuvant Nivolumab with a regimen, chemotherapy regimen, of carboplatin paclitaxel versus chemotherapy alone, given in three cycles for patients with Stage 3A non-small cell lung cancer. After the three cycle of the neoadjuvant therapy, patient proceeded with surgery, and following surgery, patient received six months of Adjuvant Nivolumab. This study was done by the Spanish Lung Cancer Group Trial. The study primary endpoint was the pathological complete response rate, and secondary endpoint, there was the major pathological response rate, as well as response rate and also adverse events. This study is important, since it's really looking in particular at the Stage 3A patients with non-small cell lung cancer. This is a challenging population. There is an evolving research and trials testing in particularly this population. We have recently reported CheckMate 816, that led to the approval of Neoadjuvant Nivolumab and chemotherapy in patients from Stage 1B to Stage 3. We have the Adjuvant therapy also approved in a patient with Stage 3. We have the patient who don't undergo resection, and they receive concurrent chemoradiation. So, what this trial is come as a validation to the CheckMate 816, looking in particularly to this patient of a Stage 3A. The result of the studies were positive. The primary endpoint, which was the pathological complete response rate, was about 36% versus 7% in the patients who did not get the immunotherapy and received the chemotherapy alone. The secondary endpoint, the major pathological response rate, which means the 10% or less of viable tumor in the resected specimen and lymph node, was 52% versus 13%. The overall response rate was 74% versus 48%. And the adverse event, there was some modest increase in the adverse event, in particularly the Grade 3, 4. It was about 24% versus 20%. This study is, again, comes as a validation for the role of Neoadjuvant chemotherapy and immunotherapy in patient with Stage 3A. This is something that has continued to evolve, as I mentioned earlier, and it's definitely set a standard of care option as one of the option for patients who potentially have resectable Stage 3 non-small cell lung cancer to receive chemotherapy and immunotherapy, followed by surgery and followed by Adjuvant immunotherapy.