Benmelstobart-anlotinib combination superior to pembrolizumab in advanced NSCLC

In patients with PD-L1-positive advanced non-small cell lung cancer (NSCLC), the combination of benmelstobart and anlotinib demonstrated superior efficacy over pembrolizumab monotherapy in the phase 3 CAMPASS trial.

Pembrolizumab monotherapy is currently a first-line standard-of-care for patients with NSCLC and high PD-L1 expression, based on earlier trials, such as KEYNOTE-042, which showed improved overall survival compared with chemotherapy [1]. However, newer combinations may offer improved outcomes. Benmelstobart, a PD-L1 inhibitor, and anlotinib, an anti-angiogenic tyrosine kinase inhibitor (TKI), are both approved in China and have shown promising efficacy in later-line treatment of advanced or metastatic NSCLC [2,3]. The phase 3 CAMPASS trial (NCT04964479) evaluated this combination in the first-line setting, directly comparing it with pembrolizumab monotherapy. A total of 531 patients were randomised 2:1 to receive benmelstobart plus anlotinib or pembrolizumab monotherapy, continued until disease progression or unacceptable toxicity. Dr Baohui Han (Shanghai Chest Hospital, China) presented the interim results [4].

After a median follow-up of 11.4 months in the combination arm and 10.6 months in the pembrolizumab arm, median progression-free survival (PFS) was significantly longer with the combination: 11.0 versus 7.1 months, corresponding to a hazard ratio (HR) of 0.70 (95% CI 0.54–0.90; P=0.0057). Subgroup analysis showed the greatest PFS benefit in participants with high PD-L1 expression (HR 0.60; 95% CI 0.41–0.88) and participants with squamous NSCLC (HR 0.63; 95% CI 0.46–0.86).

The objective response rate was also significantly higher in the combination arm compared with pembrolizumab alone (57.3% vs 39.5%; P=0.0001). Disease control rates were 85.9% versus 79.1%, respectively (P=0.047). Even though treatment-related grade ≥3 adverse events were more common with the combination (58.5% vs 29.0%), rates of treatment discontinuation were comparable (7.1% vs 8.0%).

“These results suggest that the benmelstobart plus anlotinib could represent a promising new first-line option for patients with PD-L1-positive advanced NSCLC,” said Dr Han. Still, not all patients benefit equally from checkpoint monotherapy. “Pembrolizumab is not standard-of-care across all PD-L1 levels,” noted Dr Ticiana Leal (Winship Cancer Institute, GA, USA), who commented on the findings.

1. Mok TSK, et al. Lancet. 2019;393:1819-1830.
2. Zhang W, et al. Lung Cancer. 2023;184:107353.
3. Han B, et al. JAMA Oncol. 2018; 4(11):1569-1575.
4. Han B, 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. LBA8502, ASCO Annual Meeting 2025, 30 May–3 June, Chicago, IL, USA.

Medical writing support was provided by Dr Marten Dooper.
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Posted on 4 June 202530 July 2025