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Neoadjuvant Nivolumab Demonstrated Promising Efficacy and Safety Among Patients With High-Risk Early Non-Small Cell Lung Cancer
According to results from the phase 2 POTENTIAL study, neoadjuvant nivolumab demonstrated efficacy and safety among patients with stage I non-small cell lung cancer (NSCLC), at high-risk of recurrence.
These results will be presented by Yasuhiro Tsutani, MD, PhD, Kindai University, Higashiosaka, Osaka, Japan, at the 2024 European Society for Medical Oncology (ESMO) Congress.
In this study, researchers enrolled 52 patients with a pure solid tumor with no ground-glass opacity component or a solid component measuring 2/4 cm on preoperative high-resolution computed tomography. Patients were excluded on the basis of EGFR-mutations, ALK-translocations, or ROS-1 translocations. Patients received 240 mg of neoadjuvant nivolumab once every 2 weeks for up to 3 cycles. The primary end point was pathologic complete response (pCR) rate, as assessed by central review, with a 10% threshold. Key secondary end points included safety, relapse-free survival (RFS) rate, and overall survival (OS) rate.
At the data cutoff point, the pCR rate was 23.1% and the major pCR rate was 46.2%. No new safety signals or treatment-related deaths occurred. At a median follow-up of 33.7 months, the 2-year RFS rate was 88% and the 2-year OS rate was 93.8%.
As Dr Tsutani concluded, “Neoadjuvant nivolumab demonstrated safety and efficacy in high-risk clinical stage I NSCLC.”
Source:
Tsutani Y. Sakairi Y, Ikeda N, et al. Neoadjuvant nivolumab monotherapy for high-risk clinical stage I non-small cell lung cancer: A phase II POTENTIAL study. Presented at the 2024 ESMO Congress; September 13-17, 2024. Barcelona, Spain. Abstract 1207MO
