Perioperative Nivolumab Improves Outcomes in Stage IIIA-B NSCLC

Adding perioperative nivolumab to neoadjuvant chemotherapy improves outcomes in patients with resectable stage IIIA-B non-small cell lung cancer (NSCLC), according to research published in The New England Journal of Medicine.

In this phase 2 trial, patients who received perioperative nivolumab and neoadjuvant chemotherapy had better pathologic complete response (pCR) rates, progression-free survival (PFS), and overall survival (OS) than patients who received neoadjuvant chemotherapy alone.

This trial, NADIM II (ClinicalTrials.gov Identifier: NCT03838159), included 86 patients with resectable stage IIIA or IIIB NSCLC. The patients were randomly assigned to receive neoadjuvant nivolumab and chemotherapy (n=57) or chemotherapy alone (n=29). In both arms, chemotherapy consisted of carboplatin and paclitaxel.

Patients in the nivolumab arm were more likely than those in the control arm to undergo surgery after neoadjuvant treatment — 93% and 69%, respectively (relative risk [RR], 1.35; 95% CI, 1.05-1.74).

Patients in the nivolumab arm were also more likely than those in the control arm to have R0 resections — 94% and 85%, respectively. Patients in the nivolumab arm who had R0 resections could receive adjuvant nivolumab as well. Most of those patients (84%) received at least 1 cycle of adjuvant nivolumab, and 66% received all assigned adjuvant therapy (6 months).

The pCR rate was significantly higher in the nivolumab arm than in the control arm — 37% and 7%, respectively (RR, 5.34; 95% CI, 1.34-21.23; P =.02). The researchers noted that this benefit was observed across subgroups.

All of the patients who had a pCR were still alive and free from progression at a median follow-up of 26.1 months.

The 24-month PFS rate was 67.2% in the nivolumab arm and 40.9% in the control arm (hazard ratio [HR], 0.47; 95% CI, 0.25-0.88). The 24-month OS rate was 85.0% in the nivolumab arm and 63.6% in the control arm (HR, 0.43; 95% CI, 0.19-0.98).

During neoadjuvant treatment, the rate of adverse events (AEs) was 88% in the nivolumab arm and 90% in the control arm. The rate of grade 3-4 AEs was 19% and 10%, respectively.

Treatment-related AEs that led to discontinuation of neoadjuvant treatment occurred in 4 patients in the nivolumab arm and 1 patient in the control arm. There were no AEs in either arm that delayed surgery.

Of 44 evaluable patients who received adjuvant treatment, 57% experienced any-grade AEs during the treatment, and 5% had grade 3-4 AEs.

Disclosures: This research was supported by Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference
Provencio M, Nadal E, González-Larriba JL, et al. Perioperative nivolumab and chemotherapy in stage III non-small-cell lung cancer. N Engl J Med. Published online June 28, 2023. doi:10.1056/NEJMoa2215530

This article originally appeared on Cancer Therapy Advisor