Neoadjuvant nivolumab is safe and provides a comparable pathologic response to that with cisplatin-based neoadjuvant chemotherapy in resectable non–small cell lung cancer (NSCLC), according to a study that will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
Though nivolumab is approved for the treatment of metastatic NSCLC, the role of PD-1 inhibitors in resectable NSCLC is not known. This is the first study to evaluate nivolumab in the neoadjuvant setting.
The study treated 22 patients with stage IB-IIIA NSCLC with 2 doses of 3 mg/kg of nivolumab over 4 weeks prior to tumor resection. Complete resection was not possible in 1 patient.
There were no surgery delays, and nivolumab was well-tolerated.
Major pathologic response occurred in 43% of patients (95% CI, 24-63%), and 86% were alive and recurrence-free after 9 months of median postoperative follow-up.
Exome sequencing of pretreatment tumors demonstrated an association of pathologic response with tumor mutation and predicted neoantigen loads.
Tumors with a response to nivolumab demonstrated an influx of PD-1+CD8+ T cells, and TCR sequencing showed expanded peripheral T cell clones after treatment.
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According to the investigators, the “major pathologic response rate was encouraging and compares favorably to outcomes with cisplatin-based neoadjuvant chemotherapy.”
- Chaft JE, Forde PM, Smith KN, et al. Neoadjuvant nivolumab in early-stage, resectable non-small cell lung cancers. J Clin Oncol. 2017;35(suppl; abstr 8508).