Benmelstobart plus anlotinib versus pembrolizumab as first-line treatment for PD-L1-positive advanced non–small cell lung cancer (CAMPASS)

The multicentre, blinded, randomised controlled phase 3 CAMPASS trial compared benmelstobart plus anlotinib with pembrolizumab as the first-line treatment for patients with driver-negative advanced NSCLC and a PD-L1 TPS of 1% or greater.
The primary endpoint was PFS as assessed by a blinded IRC per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1), which was defined as the time from randomisation until disease progression or all-cause death. The key secondary endpoint was OS (time from randomisation to death from any cause) and other prespecified secondary endpoints included investigator-assessed PFS, objective response rate (ORR, percentage of patients with complete or partial responses according to RECIST v1.1), disease control rate (DCR, percentage of patients with objective response and stable disease according to RECIST v1.1), duration of response (DoR, time from the first documented objective response to disease progression or all-cause death), 6-/12-month PFS rates (percentage of patients who were alive without disease progression at 6 and 12 months), and 12-month OS rate (percentage of patients who were alive at 12 months), safety, patient-reported health-related quality of life (published separately later), and immunogenicity (published separately later).
Between August 2021 and December 2022, 531 of 1420 patients assessed for eligibility were enrolled and randomly assigned to benmelstobart plus anlotinib (n=354) or pembrolizumab (n=177), composing the intention-to-treat population.
The CAMPASS trial demonstrated that benmelstobart plus anlotinib resulted in a significantly improved PFS and a better objective response compared to pembrolizumab in previously untreated, driver-negative, PD-L1-positive, advanced NSCLC, supporting benmelstobart plus anlotinib as a potential first-line treatment option in this population, especially with TPS of 50% or greater. The safety profiles were manageable and no new safety signals were observed.