The introduction of ICI therapy has led to dramatic improvements in outcomes in patients with advanced NSCLC, with many individuals achieving durable benefits. We are hopeful that the addition of ICI therapy will also increase the cure rate in patients with earlier-stage disease. There is evidence that platinum-based chemotherapy increases the cure rate in the induction setting, preoperatively, and in the adjuvant setting, postoperatively. More recently, the anti-EGFR agent osimertinib became the first targeted therapy to be approved by the US Food and Drug Administration (FDA) in the adjuvant setting for patients with NSCLC with EGFR exon 19 deletions or EGFR exon 21 L858R mutations.

Whether the advances that we are observing with ICIs in advanced-stage disease will also translate to the adjuvant or neoadjuvant setting is the subject of a number of ongoing trials, and results are beginning to emerge. At the 2021 American Society of Clinical Oncology Annual Meeting, the interim results of the phase 3 IMpower010 study were reported. Adjuvant atezolizumab was administered after chemotherapy in patients with stage II to IIIA NSCLC. The interim results showed a statistically significant improvement in disease-free survival compared with best supportive care. The magnitude of disease-free survival benefit was particularly pronounced in the PD-L1–positive population.

Other ongoing adjuvant trials include those assessing nivolumab (the ANVIL trial; NCT02595944), pembrolizumab (the PEARLS trial; NCT02504372), and durvalumab (NCT02273375).

In the neoadjuvant setting, results from the CheckMate-816 trial recently presented at the American Association for Cancer Research Annual Meeting 2021 indicated that the addition of nivolumab to chemotherapy in patients with stage IB to IIIA resectable NSCLC prior to surgery was associated with an increased pathological complete response rate compared with chemotherapy alone (24% vs 2.2%).

All of this is new territory, so we will need to watch and learn from what emerges. There are several unanswered questions. Will the ICI therapies vary in terms of benefit? How long should we use ICI treatment? And I would say that one of the most important questions is: Should we prescribe ICI therapy preoperatively, postoperatively, or both?

For now, patients need to know that they may have the opportunity to participate in pre- or postoperative ICI therapy studies, and that is part of the overall discussion of treatment for NSCLC. Thus, we are optimistic about data emerging from ICI trials in conjunction with surgery, and we hope that FDA-approved options will be available in the future.