Nivolumab Betters Event-Free Survival vs Chemo in Non-Small Cell Lung Cancer

3D rendered medical illustration of male anatomy with lung cancer: © Sebastian Kaulitzki- stock.adobe.com

The inclusion of perioperative nivolumab (Opdivo) to neoadjuvant chemotherapy delivered improvements in event-free survival (EFS) compared with chemotherapy alone in patients with resectable non-small cell lung cancer (NSCLC), according to findings from the phase 3 CheckMate 77T trial (NCT04025879).^1,2

The findings, published in The New England Journal of Medicine, showed that at a median follow-up of 25.4 months, 70.2% of patients in the nivolumab arm reached 18-month EFS vs 50.0% in the chemotherapy arm (HR, 0.58; 97.36% CI, 0.42-0.58; P <.001). Further, a pathological complete response (pCR) was observed in 25.3% and 4.7% of patients in the nivolumab and chemotherapy arms, respectively (OR, 6.64; 95% CI, 3.40-12.97), while a major pCR occurred in 35.4% and 12.1% of patients, respectively (OR, 4.01; 95% CI, 2.48-6.49).

Regarding safety, grade 3 and 4 treatment-related adverse events (AEs) were observed in 32.5% of patients in the nivolumab arm and 25.2% in the chemotherapy arm. Among patients who underwent surgery, surgery-related AEs were reported in 41.0% of patients in the nivolumab group vs 38.8% in the chemotherapy group. A total of 11.8% of patients in each group experienced grade 3 or 4 AEs.

“The rationale for the study stems from the evidence that nivolumab plus chemo is the standard of care neoadjuvant treatment for eligible patients with resectable non-small cell lung cancer, having demonstrated improvements in [event-free survival] and the pCR as compared with chemo in the CheckMate-816 study. [NCT02998528]. So, a perioperative treatment approach including adjuvant nivolumab could potentially further reduce the risk of disease relapse and improve clinical benefit in our patients with resectable non-small cell lung cancer,” Tina Cascone, MD, PhD, assistant professor, in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, said in an interview with Targeted Oncology^TM.

CheckMate 77T follows the landmark CheckMate 816 study, which showed an overall survival (OS) benefit with neoadjuvant nivolumab plus chemotherapy over chemotherapy alone at an interim analysis.2

CheckMate 77T randomized patients with stage IIA to IIIB NSCLC to receive neoadjuvant chemotherapy with or without nivolumab every 3 weeks for 4 cycles.^1,2 Surgery was then followed by neoadjuvant nivolumab or placebo every 4 weeks for 1 year. The study’s primary end point is EFS per blinded independent review, and secondary end points include pCR, major pathologic response, OS, and safety.

“As far as baseline patient characteristics, these were generally balanced between treatment arms. More than 50% of patients were from Europe, more than 20% were from Asia, approximately two-thirds of patients have stage III disease, and about 90% of patients currently smoke or have smoked in the past. More than 50% of patients had tumor PD-L1 expression of 1% or more, and about 40% of patients at tumor PD-L1 expression of less than 1% and most patients received carboplatin-based chemotherapy in both arms,” added Cascone.

REFERENCES:

1. Cascone T, Awad M, Spicer J, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769. doi:10.1056/NEJMoa2311926

2. Perioperative treatment with nivolumab results in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC. News release. ESMO. May 22, 2024. Accessed May 23, 2024. https://tinyurl.com/26d5d5de