The combination of benmelstobart, an anti–PD-L1 monoclonal antibody, and anlotinib, a multikinase inhibitor, demonstrated significantly improved survival outcomes compared to pembrolizumab monotherapy in patients with PD-L1–positive advanced non-small cell lung cancer (NSCLC), according to results from a randomized phase 3 trial.

These results will first be presented by Baohui Han, MD, Shanghai Chest Hospital, Shanghai, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting at Chicago, Illinois.

Previous research has found anti–PD-L1 monotherapy efficacious for PD-L1–positive NSCLC as a frontline treatment and anlotinib as a third-line treatment. However, research on the efficacy of benmelstobart combined with anlotinib and pembrolizumab as a frontline treatment of PD-L1–positive advanced NSCLC.

Researchers conducted a single-blind, multicenter study which enrolled 531 previously untreated patients with locally advanced or metastatic NSCLC expressing PD-L1 (tumor proportion score ≥1%). Treated patients (n = 528) were randomized 2 to 1 to receive either benmelstobart (1200 mg IV every 3 weeks) plus anlotinib (12 mg orally, days 1–14 of each 21-day cycle) or pembrolizumab (200 mg IV every 3 weeks) plus placebo.

The primary end point was progression-free survival (PFS) as assessed by independent review committee (IRC).

The median follow-up for patients treated with benmelstobart and anlotinib was 11.4 months, which was shorter than patients treated with pembrolizumab and placebo (10.6 months). The median PFS was prolonged to 11 months (95% confidence interval [CI], 9.2 to 12.6) for the benmelstobart and anlotinib group versus 7.1 months (95% CI, 5.8 to 9.5) in the pembrolizumab and placebo (hazard ratio [HR], 0.70; 95% CI, 0.55 to 0.91; P = .007).

Subgroup analysis showed greater benefit for patients with squamous cell carcinoma (HR, 0.63; 95% CI, 0.46 to 0.86) and PD-L1 expression ≥50% (HR, 0.60; 95% CI, 0.41 to 0.88).

Additionally, the confirmed objective response rate was also significantly higher in the benmelstobart and anlotinib group compared with the pembrolizumab and placebo group (57.3% vs 39.6%; P <.001).

Treatment-related adverse events of any grade occurred in 98.3% of patients in the benmelstobart and anlotinib group and 88.1% in the pembrolizumab and placebo group. Grade ≥3 treatment-related adverse events were more frequent among patients treated with benmelstobart and anlotinib than patients who received pembrolizumab and placebo (58.5% vs 29%).

"To our knowledge, this is the first phase III study to demonstrate the significant PFS benefit of a multikinase inhibitor plus an anti-PD-L1 mAb in the first-line treatment of PD-L1-positive aNSCLC compared to pembrolizumab," the researchers concluded.

Source:

Han B, Yang R, Yongzhong L, et al. CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC)—A randomized, single-blind, multicenter phase 3 study. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract LBA8502.