Dr Halmos on Selection Criteria for Adjuvant Therapy After Chemo/IO in NSCLC

"This is an evolving space. What's very clear is that the category of patients [who achieve] a pCR, which is about a quarter of the patients, have outstanding OS [outcomes]. Can we improve that prognosis further with adjuvant treatment? We're not sure, but it will be hard [to do]."

Balazs Halmos, MD, professor in the Department of Oncology (Medical Oncology) and Department of Medicine (Oncology & Hematology) and associate director of Clinical Science at Montefiore Einstein Comprehensive Cancer Center, discussed evolving considerations for selecting patients for additional adjuvant therapy after neoadjuvant chemoimmunotherapy and surgery in resectable non–small cell lung cancer (NSCLC), based on recent data from the 2025 Bridging the Gaps in Lung Cancer consensus meeting.

Halmos noted that ongoing advances in the perioperative setting are reshaping treatment decisions, particularly in the context of pathological response. In the phase 3 CheckMate 816 trial (NCT02998528), neoadjuvant nivolumab (Opdivo) plus chemotherapy yielded a pathological complete response (pCR) rate of approximately 24% in concurrently randomized patients, with higher rates observed among patients with PD-L1–high tumors. For patients who achieved a pCR in the nivolumab arm, the median overall survival was not reached, underscoring their favorable long-term prognosis.

Given these outcomes, the potential benefit of adding further adjuvant therapy in pCR patients remains uncertain, Halmos explained. Because their prognosis is already excellent, demonstrating a survival advantage from additional treatment will be challenging. As such, observation with close surveillance is considered a reasonable management strategy for this subgroup, he said.

For patients without a pCR, the decision-making process is more nuanced, Halmos continued. Residual disease following neoadjuvant therapy may indicate a higher risk of recurrence, supporting consideration of additional systemic treatment in the adjuvant setting. However, selection should incorporate clinical, pathological, and biomarker-driven risk assessment to optimize therapeutic benefit while minimizing overtreatment.

Halmos also highlighted the role of clinical trials in refining these strategies. Randomized studies comparing observation versus adjuvant immunotherapy or other targeted approaches in patients with pCR could help clarify whether further intervention meaningfully improves outcomes, he concluded.