Consolidation therapy with benmelstobart in stage III NSCLC

Programmed cell death-ligand 1 (PD-L1) inhibitor benmelstobart provides an effective consolidation therapy for participants with unresectable stage III non-small cell lung cancer (NSCLC), delivering a substantial progression-free survival (PFS) benefit and a manageable safety profile, as shown in the Chinese phase 3 R-ALPS study.

In 2017, the management of stage III NSCLC underwent a change with the publication of the PACIFIC trial (NCT02125461), which demonstrated a significant improvement in both PFS and overall survival in patients without disease progression after chemoradiation therapy who received durvalumab consolidation therapy [1]. “However, durvalumab (and other PD-L1 inhibitors) was not available in China until 2019,” explained Prof. Ming Chen (Sun Yat-sen University Cancer Center, China) [2]. Instead, the PD-L1 inhibitor benmelstobart was developed, and the current phase 3 R-ALPS study (NCT04325763) investigated the efficacy and safety of consolidation treatment with benmelstobart with and without the anti-angiogenic tyrosine kinase inhibitor anlotinib [2].

A total of 553 participants with unresectable stage III NSCLC who had not progressed after chemoradiation were 1:1:1 randomised to receive benmelstobart-anlotinib, benmelstobart monotherapy or placebo. The primary endpoint was PFS; key secondary endpoints were overall survival, objective response rate, and safety.

Median PFS was 15.1 (95% CI 9.4–21.7) months, 9.7 (95% CI 6.0–34.4) months, and 4.2 (95% CI 3.2–6.8) months, in the benmelstobart-anlotinib arm, the benmelstobart monotherapy arm and the placebo arm, respectively. The PFS benefit of benmelstobart-anlotinib and benmelstobart monotherapy over placebo was observed across all subgroups. The objective response rates were 25.6%, 23.3%, and 12.9%, and the disease control rates were 84.5%, 86.1%, and 70.5%, respectively. Treatment-related events grade 3–5 were observed in 49.8%, 31.8%, and 21.2%, respectively. Overall survival data are not yet mature.

Prof. Chen concluded that benmelstobart with or without anlotinib provides an effective consolidation therapy for unresectable stage III NSCLC, delivering substantial PFS benefits with a manageable safety profile.

1. Antonia SJ, et al. N Engl J Med. 2017;377(20):1919–1929.
2. Chen M, et al. R-ALPS study: a randomized, double-blind, multicenter, phase III trial of benmelstobart with or without anlotinib as consolidation therapy following chemoradiotherapy for patients with unresectable stage III non-small lung cancer. Abstract LBA8004, ASCO Annual Meeting 2025, May 30–June 3, Chicago, IL, USA.

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Posted on 30 July 2025