GASTO-1901 Trial Evaluates Nivolumab Consolidation After Neoadjuvant Therapy Plus CCRT in Unresectable Stage III NSCLC

Patients with unresectable stage III non-small cell lung cancer (NSCLC) lived longer without disease progression following nivolumab (Opdivo) consolidation therapy compared with patients who only received neoadjuvant therapy and concurrent chemo-radiotherapy (CCRT), according to a recent study.

The phase 2 randomized, multi-center clinical trial investigated progression-free survival (PFS) in 264 patients who underwent neoadjuvant therapy consisting of docetaxel, cisplatin, and nivolumab. Hypo-CCRT was given to 242 patients. Patients were then randomly selected to either receive nivolumab consolidation (n=86) or observation (n=86).

To be eligible for the study, patients were required to have an Eastern Oncology Cooperative Group performance status of 0 or 1 and be aged 18-75 years old. Patients with prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy were excluded.

The secondary endpoints of the GASTO-1901 trial were overall survival, objective response rate, symptoms and health-related quality of life, and adverse events (AEs).

Findings of the trial were presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. At 22.8 months, the nivolumab consolidation group showed significantly longer PFS compared with the observation group (median not reached vs 12.2 months, respectively).

In the consolidation group, the 12- and 18-month PFS rates were 72.6% and 64.8% versus 52.5% and 42.3%, respectively, in the observation group.

“Consolidation with nivolumab after neoadjuvant chemotherapy plus nivolumab and hypo-CCRT demonstrates effectiveness and tolerability for patients with unresectable stage III NSCLC,” the researchers said.

Patients in both groups experienced AEs. During neoadjuvant therapy and hypo-CCRT, a grade 3-4 nonhematological AE occurred in 14% (n=37/264) of patients.

Following randomization, grade 3-5 AEs happened in 7% (n=6/86) of patients in the consolidation group. They included grade 3 pneumonitis (2.3%), grade 3 proximal bronchial tree toxicity (3.5%), and grade 5 pneumonitis (1.2%).

In the observation group, grade 3 AEs were seen in 4.6% (n=4/86) of patients. They were grade 3 pneumonitis (2.3%) and grade 3 proximal bronchial tree toxicity (2.3%).

Although these findings are promising, the researchers said extended follow-up of nivolumab consolidation is essential.

Reference

Liu H, Qiu B, Zhao Y, et al. A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091). Abstract #8008. Presented at the 2024 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024, Chicago, Illinois.