Adding nivolumab to platinum-based chemotherapy prior to surgery can improve survival in patients with stage IIIA-B non-small cell lung cancer (NSCLC), according to results presented at the IASLC 2022 World Conference on Lung Cancer.1
The results, from the NADIM II trial, showed that nivolumab improved both progression-free survival (PFS) and overall survival (OS).
This is the first clinical trial to show improved OS with a neoadjuvant immunotherapy-based combination in this patient population, said study presenter Mariano Provencio, MD, PhD, of the Hospital Universitario Puerta de Hierro-Majadahonda in Madrid.
The phase 2 trial (ClinicalTrials.gov Identifier: NCT03838159) enrolled 86 patients with locally advanced, potentially resectable, stage IIIA-B NSCLC with no known alterations in EGFR or ALK.
Patients were randomly assigned to receive 3 cycles of neoadjuvant chemotherapy alone (n=29) or in combination with nivolumab (n=57). Chemotherapy consisted of paclitaxel (200 mg/m2) and carboplatin (AUC5) every 3 weeks. Nivolumab was given at 360 mg every 3 weeks.
At baseline, the median age was 63 (range, 58-70) years in the nivolumab arm and 62 (range, 57-66) years in the chemotherapy-alone arm. Less than half of patients were women (36.8% and 44.8%, respectively), and most had adenocarcinoma (43.9% and 37.9%) or squamous NSCLC (36.8% and 48.3%).
After completing neoadjuvant treatment, patients underwent surgery. Those with R0 resection in the chemotherapy-alone arm (n=13) underwent observation for 6 months, and those with R0 resection in the nivolumab arm (n=49) received adjuvant nivolumab (480 mg every 4 weeks) for 6 months.
The study’s primary endpoint is pathological complete response (pCR) rate, which was previously reported.2 The pCR rate was 36.8% in the nivolumab arm and 6.9% in the chemotherapy-alone arm (odds ratio, 7.88; 95% CI, 1.70-36.51; P =.0068).
For the current analysis, the median follow-up was 26.1 months. The median PFS was not reached in the nivolumab arm and was 18.3 months in the chemotherapy-alone arm (hazard ratio [HR], 0.48; 95% CI, 0.25-0.91; P =.025).
The 12-month PFS rate was 89.3% in the nivolumab arm and 60.7% in the chemotherapy-alone arm (P =.001). The 24-month PFS rate was 66.6% and 42.3%, respectively (P =.012).
The median OS was not reached in either arm (HR, 0.40; 95% CI, 0.17-0.93; P =.034). The 12-month OS rate was 98.2% in the nivolumab arm and 82.1% in the chemotherapy-alone arm (P =.007). The 24-month OS rate was 84.7% and 63.4%, respectively (P =.014).
These results confirm the superiority of neoadjuvant nivolumab plus chemotherapy in patients with resectable, stage IIIA-B NSCLC, Dr Provencio concluded.
Disclosures: This research was supported, in part, by Bristol Myers Squibb. Dr Provencio declared affiliations with Bristol Myers Squibb, AstraZeneca, Roche, Boehringer Ingelheim, Celgene, Merck Sharp & Dohme, Takeda, and Thermo-Fisher.
1. Provencio M, Serna R, Nadal E, et al. Progression-free survival and overall survival in NADIM II study. Presented at WCLC 2022. August 6-9, 2022. Abstract 1988.
2. Provencio-Pulla M, Nadal E, Gonzalez Larriba JL, et al. Nivolumab + chemotherapy versus chemotherapy as neoadjuvant treatment for resectable stage IIIA NSCLC: Primary endpoint results of pathological complete response (pCR) from phase II NADIM II trial. Presented at ASCO 2022; June 3-7, 2022. Abstract 8501.