Neoadjuvant Nivolumab Plus Chemotherapy Improves EFS vs Chemotherapy Alone in Resectable NSCLC

Neoadjuvant nivolumab plus chemotherapy for resectable non-small-cell lung carcinoma (NSCLC) was associated with prolonged event-free survival (EFS) and a higher percentage of patients with a pathologic complete response (PCR) compared to chemotherapy alone, according to findings from a phase 3 trial.

“Nivolumab-based regimens have shown a survival benefit in patients with metastatic NSCLC,” explained Patrick M. Forde, MB, BCh, Johns Hopkins Kimmel Cancer Center, Baltimore, MD, and colleagues.

“Although recent advances have been made with adjuvant therapies for resectable NSCLC, effective systemic treatments continue to be needed for nonmetastatic disease across perioperative contexts,” they added.

This open-label, phase 3 trial aimed to assess the clinical benefit of nivolumab plus platinum-based chemotherapy compared to platinum-based chemotherapy alone in resectable NSCLC.

The primary end points of the trial were EFS and pathological complete response, defined as 0% viable tumor in resected lung and lymph nodes. Secondary end points included overall survival and safety.

The median EFS was 31.6 months (95% confidence interval [CI], 30.2 to not reached) with nivolumab plus chemotherapy and 20.8 months (95% CI, 14.0 to 26.7) with chemotherapy alone (hazard ratio for disease progression, disease recurrence, or death, 0.63; 97.38% CI, 0.43 to 0.91; P = .005). The percentage of patients with a pathological complete response was 24% (95% CI, 18 to 31) and 2.2% (95% CI, 0.6 to 5.6), respectively (odds ratio, 13.94; 99% CI, 3.49 to 55.75; P <.001).

“Results for event-free survival and pathological complete response across most subgroups favored nivolumab plus chemotherapy over chemotherapy alone,” wrote Dr Forde and colleagues.

The most common treatment-related adverse events were neutropenia (8.5% with nivolumab plus chemotherapy and 11.9% with chemotherapy alone) and decreased neutrophil count (7.4% and 10.8%, respectively).

“The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence of adverse events or impede the feasibility of surgery,” concluded Dr Forde et al.

Source:                                        

Forde PM, Spicer J, Lu S, et al. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N Engl J Med. 2022;386(21):1973-1985. doi:10.1056/nejmoa2202170.