Camrelizumab Combo Shows Sustained Benefit in Resectable NSCLC

Neoadjuvant therapy with camrelizumab plus apatinib (Aitan) produced long-term efficacy among patients with resectable stage IIA to IIIB non–small cell lung cancer (NSCLC), according to 3-year findings from a phase 2 study (ChiCTR2000033588) published in the European Journal of Cancer.

Data showed that the median event-free survival (EFS) and disease-free survival (DFS) were not reached (NR); the 3-year rates for each respective end point were 58.9% (95% CI, 46.9%-69.1%) and 61.5% (95% CI, 48.6%-72.1%). The median time to disease recurrence among those whose disease recurred was 39.7 months (IQR, 16.1-45.4). Although overall survival (OS) data were immature at the time of analysis, the estimated OS rate at 3 years was 92.3% (95% CI, 83.6%-96.5%). Subgroup data demonstrated significantly improved EFS outcomes among those with squamous cell carcinoma (HR, 0.46; 95% CI, 0.22-0.95; P = .032), postoperative stage 0 or I disease (HR, 0.37; 95% CI, 0.16-0.82; P = .011), and postoperative stage N0 status (HR, 0.31; 95% CI, 0.14-0.69; P = .002).

The neoadjuvant regimen yielded a major pathological response (MPR) in 56.9% of patients and a pathologic complete response (pCR) in 23.1%. Those who achieved an MPR tended to have numerically improved EFS (HR, 0.49; 95% CI, 0.22-1.07; P = .0681) and DFS outcomes (HR, 0.49; 95% CI, 0.23-1.08; P = .0698), with similar trends reported for those with a pCR in terms of EFS (HR, 0.58; 95% CI, 0.20-1.69; P = .3118) and DFS (HR, 0.59; 95% CI, 0.20-1.70; P = .3201).

Among patients with a complete or partial metabolic response, improvements in EFS (HR, 0.23; 95% CI, 0.08-0.62; P = .0016) and DFS (HR, 0.26; 95% CI, 0.09-0.74; P = .0065) occurred compared with those with stable or progressive metabolic disease following neoadjuvant treatment. Additionally, clearance of circulating tumor DNA (ctDNA) during the perioperative period correlated with favorable EFS outcomes (HR, 0.23; 95% CI, 0.09-0.59; P = .0009).

“The 3-year follow-up data demonstrate the potential sustained efficacy of neoadjuvant camrelizumab plus apatinib in resectable NSCLC. These data also support the roles of metabolic response on PET/CT and ctDNA clearance as potential biomarkers for predicting EFS,” lead study author Wei Guo, from the Department of Thoracic Surgery at National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing, China, wrote with coauthors. “These findings provide preliminary evidence for this neoadjuvant combined strategy as a promising option for patients with resectable NSCLC, particularly for those who are intolerant of or refuse chemotherapy.”

In this single-center, single-arm trial, 62 patients received 3 cycles of neoadjuvant treatment consisting of camrelizumab at 200 mg intravenously every 2 weeks plus apatinib at 250 mg orally once daily for 5 days on and 2 days off. Following surgery, investigators administered adjuvant camrelizumab alone at 200 mg intravenously every 2 weeks for up to 12 cycles after 4 to 8 weeks.

The trial’s primary end point was the MPR rate. Secondary end points included the pCR rate, objective response rate, disease control rate, EFS, DFS, and safety. Patients 18 to 70 years old with previously untreated resectable stage IIA to IIIB NSCLC and an ECOG performance status of 0 or 1 were eligible for enrollment on the trial.

Regarding baseline characteristics, 76% of patients had squamous cell carcinoma, while 24% had adenocarcinoma. N2 lymph node status was reported in 34.6% of patients. Investigators conducted surgery for 83.3% of patients, and 95.4% of those patients received subsequent adjuvant therapy. The most common adjuvant regimens included camrelizumab monotherapy (83.9%), camrelizumab plus chemotherapy (11.3%), sintilimab (Tyvyt) plus chemotherapy (3.2%), and osimertinib (Tagrisso; 1.6%).

Based on multivariate analysis, metabolic response per PET/CT (HR, 0.26; 95% CI, 0.07-0.93; P = .038) and ctDNA clearance during any treatment period (HR, 7.94; 95% CI, 1.67-37.76; P = .009) independently correlated with EFS. These respective factors were also associated with DFS (HR, 0.27; 95% CI, 0.07-0.95; P = .042; HR, 6.94; 95% CI, 1.47-32.68; P = .014).

Reference

Guo W, Zhao L, Chen X, et al. Phase II trial of neoadjuvant camrelizumab and apatinib in resectable NSCLC: 3-year survival outcomes and dynamic circulating tumor DNA analyses. Eur J Cancer. 2026;234:116198. doi:10.1016/j.ejca.2025.116198.