Adding nivolumab to stereotactic ablative radiotherapy (SABR) improves event-free survival (EFS) in patients with early-stage non-small cell lung cancer (NSCLC), according to findings presented at the 2023 World Conference on Lung Cancer.1
Nivolumab plus SABR could be a treatment option for these patients, but results from ongoing phase 3 studies are needed to establish the standard of care, said study presenter Joe Y. Chang, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston.
Dr Chang presented results with SABR and nivolumab from a phase 2 trial (ClinicalTrials.gov Identifier: NCT03110978). The trial included 156 adults with treatment-naive, stage I-II NSCLC or NSCLC with isolated parenchymal recurrences.
The patients were randomly assigned to receive SABR alone (n=78) or nivolumab plus SABR (n=78). Patients in both arms received SABR at 50 Gy in 4 fractions or 70 Gy in 10 fractions. Patients in the nivolumab arm received the drug at 480 mg every 4 weeks for 12 weeks.
Baseline characteristics were generally well balanced between the arms. However, patients in the nivolumab arm were more likely to be women (70% vs 55%), be White (94% vs 85%), have recurrent lung cancer (24% vs 16%), and have larger tumors (median, 2.0 cm and 1.7 cm, respectively).
Among patients treated per protocol, the 4-year EFS rate was 77% in the nivolumab arm and 53% in the SABR-alone arm (hazard ratio [HR], 0.38; 95% CI, 0.19-0.75; P =.0056). Results were similar in the intent-to-treat population (HR, 0.42; 95% CI, 0.22-0.80; P =.008).
The rate of local failure was 13.3% in the SABR-alone arm and 0% in the nivolumab arm. The rate of regional failure was 10.7% and 6.1%, respectively. The rate of distant failure was 16% and 3%, respectively. The rate of second primary lung cancer was 8% and 3%, respectively.
Overall, 64% of patients in the SABR-alone arm and 87.9% of those in the nivolumab arm were alive and free from relapse at last follow-up. The proportion of patients who died was 12% and 6.1%, respectively.
Grade 2 pneumonitis occurred in 2 patients who received nivolumab plus SABR and 1 patient who received SABR alone. Grade 2-3 fatigue occurred in 9 patients in the nivolumab arm and 1 in the SABR-alone arm.
These results were recently published in The Lancet as well.2
Disclosures: This research was partly supported by Bristol-Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the Lancet article for a full list of disclosures.
1. Chang JY, Lin SH, Dong W, et al. Nivolumab after stereotactic ablative radiotherapy for early-stage non-small cell lung cancer: Randomized I-SABR Trial. Presented at WCLC 2023. September 9-12, 2023. Abstract OA12.04.
2. Chang JY, Lin SH, Dong W, et al. Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: An open-label, randomised, phase 2 trial. Lancet. 2023;402(10405):871-881. doi:10.1016/S0140-6736(23)01384-3.