Data from the phase 2 NADIM II trial appear to reinforce the superiority of nivolumab and chemotherapy vs chemotherapy alone after the regimen significantly improved overall survival progression-free survival, and pathologic complete response in patients with stage IIIA/B non–small cell lung cancer, according to investigators.
Treatment with nivolumab (Opdivo) and chemotherapy in patients with stage IIIA/B non–small cell lung cancer yielded significantly improved survival and responses, according to data from the phase 2 NADIM II study (NCT03838159) presented at the 2022 World Conference on Lung Cancer.
Patients who received the nivolumab/chemotherapy combination demonstrated 12- and 24-month progression-free survival (PFS) rates of 89.3% and 66.6%, respectively, compared with 60.7% and 42.3% with chemotherapy alone. Median PFS was not reached in the experimental cohort compared with 18.3 months in the chemotherapy cohort (HR, 0.48; 95% CI, 0.25-0.91; P = .025).
The overall survival (OS) rates at 12 and 24 months were 98.2% and 84.7%, respectively, in the nivolumab plus chemotherapy cohort, compared with 82.1% and 63.5% in the chemotherapy cohort. Median OS was not reached in either arm (HR, 0.40; 95% CI, 0.17-0.93; P = .034).
In addition, PFS and OS probabilities showed that patients who achieved a pathological complete response (pCR) did not die or progress following treatment.
“Our conclusion is that [this] confirms the superiority of nivolumab plus chemotherapy in the neoadjuvant setting,” lead author Mariano Provencio Pulla, MD, PhD, head of the Department of Medical Oncology at Puerta de Hierro University Hospital, said during a presentation on the findings. “Neoadjuvant nivolumab plus chemotherapy significantly improved the pCR, improved PFS, and improved the [OS].”
A total of 90 patients enrolled on the study, 57 of whom were included in the nivolumab arm and 29 in the chemotherapy arm. Within the experimental arm, 59.6% of patients went on to receive maintenance therapy. The trial included patients with locally advanced, potentially resectable stage IIA/IIIB disease. Patients were randomized 2:1 to receive either 360 mg of nivolumab plus 200 mg/m2 of paclitaxel plus carboplatin ever 3 weeks for 3 cycles, or the chemotherapy backbone alone. Patients then underwent surgery followed by adjuvant nivolumab at 480 mg for 6 months in the experimental arm, vs observation every 12 weeks for 6 months in the control arm. Follow up was 5 years.
The primary end point was pCR within the intent to treat population, with secondary end points including major pathological response, safety, OS, and PFS.
Patients in the experimental arm had a median age of 63 years compared with 62 years in the control arm. Most patients across both respective arms were current smokers (50.9% vs 65.5%, respectively), with fewer being former smokers (40.4% vs 44.8%) and never smokers (8.7% vs 0.0%). Additionally, most patients across both groups had adenocarcinoma (43.9% vs 37.9%) and squamous histology (36.8% vs 48.3%).
Definitive surgery was performed in 93.0% of patients in the experimental arm compared with 69.0% of patients in the control arm (odds ratio [OR], 5.96; 95% CI, 1.65-21.56; P = .00807). Across the overall patient population, 11.0% of patients underwent pneumonectomy, 78.1% received a lobectomy, 6.8% received a bilobectomy, 2.7% received a segmentectomy, and 1.4% received a right lower lobectomy and segmentectomy. A total of 92.5% of those in the combination arm and 65.0% in the chemotherapy alone arm received an R0 resection (OR, 6.60; 95% CI, 1.67-26.02; P = .007). Moreover, the downstaging rate was 69.8% in the nivolumab arm vs 40.0% in the chemotherapy arm (OR, 3.47; 95% CI, 1.19-10.1; P = .04).
Provencio M, Serna R, Nadal E, et al. Progression free survival and overall survival in NADIM II study. Presented at 2022 World Conference on Lung Cancer; August 6-9, 2022; Vienna, Austria; abstract PL03.12.