Key Takeaways & Executive Findings
- •• • Major pathological response (MPR) rate of 60% (18/30) in resectable stage IIIA NSCLC, significantly higher than historical chemotherapy alone (15-20%), indicating enhanced tumor regression. • • Pathological complete response (pCR) rate of 33.3% (10/30), a key surrogate for long-term survival, suggesting potential for improved disease-free survival. • • Overall response rate (ORR) of 70% (21/30) by RECIST 1.1, demonstrating rapid tumor shrinkage and high clinical activity. • • Grade ≥3 treatment-related adverse events occurred in 20% of patients, with no treatment-related deaths, indicating a manageable safety profile suitable for perioperative use.
Abstract
This prospective phase II trial evaluated the efficacy and safety of neoadjuvant chemotherapy combined with anti-PD-1 immunotherapy in patients with resectable non-small cell lung cancer (NSCLC). A total of 30 patients with stage IIIA NSCLC received two cycles of platinum-based chemotherapy plus pembrolizumab (200 mg) prior to surgery. The primary endpoint was major pathological response (MPR), defined as ≤10% viable tumor cells in the resected specimen. Secondary endpoints included pathological complete response (pCR), overall response rate (ORR), and safety. Results demonstrated an MPR rate of 60% (18/30) and a pCR rate of 33.3% (10/30). The ORR was 70% (21/30) by RECIST 1.1. Grade 3 or higher treatment-related adverse events occurred in 20% of patients, with no treatment-related deaths. The combination regimen showed promising antitumor activity with manageable toxicity, supporting further investigation in larger randomized trials.
1. Introduction
Non-small cell lung cancer (NSCLC) remains a leading cause of cancer-related mortality worldwide. For patients with resectable disease, surgical resection followed by adjuvant chemotherapy has been the standard of care, yet recurrence rates remain high, particularly in stage IIIA disease. The advent of immune checkpoint inhibitors targeting PD-1/PD-L1 has revolutionized the treatment of advanced NSCLC, but their role in the neoadjuvant setting is still evolving. Early-phase trials have suggested that neoadjuvant immunotherapy combined with chemotherapy can induce robust pathological responses, potentially eradicating micrometastatic disease and improving long-term outcomes. However, the optimal regimen, patient selection, and biomarkers of response are yet to be defined.
This prospective phase II trial was designed to evaluate the efficacy and safety of neoadjuvant chemotherapy (platinum-based doublet) combined with pembrolizumab in patients with resectable stage IIIA NSCLC. The primary endpoint was major pathological response (MPR), a validated surrogate for survival in this setting. By integrating immunotherapy into the neoadjuvant window, we aimed to harness the antitumor immune response while the primary tumor is still in situ, potentially enhancing systemic tumor control. The results demonstrate a high MPR rate of 60% and a pCR rate of 33.3%, with manageable toxicity, supporting the further development of this approach in larger randomized trials.
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ZHANG Wei, LI Ming, WANG Fang, et al. (2025). Efficacy of Neoadjuvant Chemotherapy Combined with Anti-PD-1 Immunotherapy in Resectable Non-Small Cell Lung Cancer: A Prospective Phase II Trial. Chinese Journal of New Drugs. https://doi.org/pub_80__articleID_254
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Frequently Asked Questions
What is the rationale for using MPR as the primary endpoint in this neoadjuvant trial?
MPR, defined as ≤10% viable tumor cells in the resected specimen, has been validated as a surrogate for overall survival in multiple neoadjuvant lung cancer trials. In our study, an MPR rate of 60% (18/30) was achieved, which is substantially higher than historical chemotherapy alone (15-20%), indicating a strong antitumor effect that may translate into improved survival.
How does the safety profile of this combination compare to standard neoadjuvant chemotherapy?
The incidence of grade ≥3 treatment-related adverse events was 20%, which is comparable to chemotherapy alone (typically 30-40%). Importantly, no treatment-related deaths occurred, and immune-related adverse events were manageable with standard protocols. This suggests that the addition of pembrolizumab does not significantly increase toxicity in the perioperative setting.
What are the implications of the 33.3% pCR rate for long-term outcomes?
pCR is associated with excellent long-term survival in NSCLC. A pCR rate of 33.3% (10/30) is among the highest reported for neoadjuvant chemo-immunotherapy, suggesting that a substantial proportion of patients may achieve durable remission. This could lead to improved disease-free and overall survival, though longer follow-up is needed.
Were there any biomarkers predictive of response to this regimen?
While PD-L1 expression and tumor mutational burden (TMB) were exploratory biomarkers, the small sample size precluded definitive conclusions. However, subgroup analyses suggested that patients with PD-L1 ≥50% had higher MPR rates, consistent with prior studies. Future trials should incorporate comprehensive biomarker analysis to optimize patient selection.
What are the next steps for this research?
Given the promising efficacy and manageable safety, a phase III randomized trial comparing neoadjuvant chemo-immunotherapy versus chemotherapy alone is warranted. Additionally, translational studies are needed to identify predictive biomarkers and mechanisms of resistance, which will guide personalized treatment strategies.
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