CAMPASS: Benmelstobart Plus Anlotinib Shows Superior PFS in PD-L1 Positive Advanced NSCLC

Phase 3 data from CAMPASS, a randomized, single-blind, multicenter trial, demonstrated that the combination of benmelstobart, a humanized anti–PD-L1 monoclonal antibody, and anlotinib, a multikinase inhibitor, significantly improves progression-free survival (PFS) versus pembrolizumab alone in the first-line treatment of PD-L1–positive advance non–small cell lung cancer (NSCLC).

Baohui Han, MD, PhD, of the Shanghai Chest Hospital, and colleagues conducted the study and presented the phase 3 results at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

It was important to perform this research because although anti–PD-L1 monotherapy has been the standard first-line treatment for PD-L1–positive NSCLC, the clinical benefit of the treatment “remains unsatisfactory.” The goal of this phase 3 study was to compare the efficacy data of this drug combination with that of pembrolizumab monotherapy.

Eligible patients included those who were treatment naive to previous systemic therapy, diagnosed with locally advanced or recurrent or metastatic NSCLC with PD-L1–positive expression. PD-L1–positive expression was defined as a tumor proportion score of 1% or higher.

Patients were randomized 2:1 to receive either the combination of benmelstobart plus anlotinib or pembrolizumab plus placebo. Benmelstobart (1,200 mg/d) or pembrolizumab (200 mg/d) was administered IV on the first day of a 21-day cycle, and anlotinib (12 mg/d) or placebo (0 mg/d) was administered orally on days 1 to 14 of the 21-day cycle.

The researchers explained that the primary end point was PFS as evaluated by an independent review committee.

From August 2021 to December 2022, 531 patients were randomized for treatment, and a total of 528 patients were treated. The data cutoff was May 20, 2023, and the median follow-up PFS at that time was 11.4 months for the benmelstobart plus anlotinib group and 10.6 months for the pembrolizumab plus placebo group.

The investigators highlighted that the study met its primary end point, demonstrating a “significantly prolonged” median PFS of 11 months (95% CI, 9.2-12.6) in the benmelstobart plus anlotinib group versus 7.1 months (95% CI, 5.8-9.5) in the pembrolizumab plus placebo group (P=0.007).

They also noted that the hazard ratio (HR) was 0.70 (95% CI, 0.55-0.91), and the HR for patients with squamous cell carcinoma plus PD-L1 expression of 50% or higher was 0.63 (95% CI, 0.46-0.86) and 0.60 (95% CI, 0.41-0.88), respectively. In addition, the objective response rate) was confirmed to be higher in the benmelstobart plus anlotinib arm versus the pembrolizumab plus placebo arm (57.3% vs 39.6%; P<0.001).

Moreover, the overall survival (OS) data were reported as “immature.” The investigators also evaluated treatment-related adverse events (TRAE) and found that 98.3% of patients in the benmelstobart plus anlotinib group and 88.1% of those in the pembrolizumab plus placebo group experienced at least one TRAE, with the incidence of grade 3 or higher TRAE being 58.5% and 29%, respectively.

“Tolerability is favourable with a lower incidence of treatment discontinuation due to TRAE, the researchers concluded. “The data support this combination as a new option for these pts [patients].”