On August 6, the 12th indication for Anlotinib Hydrochloride Capsules (Fukewei^®), independently developed by SBP Group's (1177.HK) core enterprise Chia Tai Tianqing, was approved for marketing. The indication is for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC), using Benmelstobart Injection combined with paclitaxel and carboplatin, followed by sequential treatment with this product combined with Benmelstobart Injection. This approval is based on the positive clinical results of the ETER700 study—the world's first first-line treatment combination for sq-NSCLC to be validated in a head-to-head Phase III clinical trial as significantly superior to an immune checkpoint inhibitor combined with platinum-based chemotherapy. 

The approval of this indication marks the official entry of first-line sq-NSCLC treatment into a new era of "immune combination with anti-angiogenesis," which is expected to bring more potent and lasting hope for survival to a broad range of patients. 

The Urgent Need to Break Through the Chemo-Immuno Combination Ceiling

sq-NSCLC is one of the main histological subtypes of lung cancer. Due to its unique biological characteristics, progress in the field of targeted therapy has been relatively slow. In recent years, immunotherapy represented by PD-1/PD-L1 inhibitors combined with chemotherapy has become the standard first-line treatment for advanced sq-NSCLC, significantly improving the survival prognosis for the overall population. However, its clinical application still faces certain limitations: some patients fail to achieve lasting survival benefits, or experience rapid disease progression after an initial response. Therefore, exploring new regimens that can further improve the efficacy of first-line treatment and delay drug resistance is a pressing issue in the clinical treatment of sq-NSCLC. 

Studies have shown that anti-angiogenic drugs can synergize with immunosuppressants by promoting tumor vessel normalization and improving the tumor microenvironment[1]. As one of the representative drugs, Anlotinib has accumulated a large body of evidence-based medical evidence and has demonstrated robust anti-tumor activity in multiple indications, including later-line treatment for non-small cell lung cancer. However, for sq-NSCLC patients with a high proportion of central lesions, the application of first-line anti-angiogenic therapy may pose a higher risk of haemorrhage. To address this challenge, this study adopted an innovative clinical trial design, with sequential Benmelstobart combined with Anlotinib following Benmelstobart combined with chemotherapy. The results of the ETER700 study validated the scientific and rational basis of the "chemotherapy plus immune for rapid tumor shrinkage + targeted plus immune for sequential efficacy enhancement" treatment model, which controls safety risks while improving clinical benefits. 

ETER700 Study Shows Significant Improvement in PFS and OS

The ETER700 study is the world's first Phase III clinical study to validate that an immune-chemotherapy combination followed by a sequential combination with an anti-angiogenic drug achieves significant improvement in the first-line treatment of sq-NSCLC, in a head-to-head comparison against the standard immune-chemotherapy regimen^[2]. 

Clinical data showed that compared to the standard "immuno (tislelizumab) + chemotherapy" control group, the experimental group (Benmelstobart + chemotherapy sequentially combined with Anlotinib) achieved a median progression-free survival (PFS) of 11.20 months, versus 8.28 months in the control group. The hazard ratio (HR) was 0.68 (95% CI: 0.53, 0.88, p=0.0026), representing a 32% reduction in the risk of disease progression or death. The median overall survival (OS) in the experimental group has not yet been reached, while the median OS in the control group was 26.45 months, with an HR of 0.75 (95% CI: 0.59, 0.96, p=0.0199), showing a significant trend of OS benefit. 

In addition to the improvement in PFS, the Anlotinib combination regimen also showed advantages in the depth and durability of tumor response. The objective response rate (ORR) in the experimental group reached 76.33%, compared to 71.78% in the control group. Meanwhile, the median duration of response (DoR) in the experimental group was 13.14 months, compared to 11.07 months in the control group. Subgroup analysis results showed that the PFS benefit was consistent across almost all subgroups, including patients of different ages, ECOG PS scores, PD-L1 expression levels, and number of metastatic sites. The improvement in PFS was particularly significant in patient populations with an ECOG PS of 0, PD-L1 TPS of 1-49%, and age <65 years. 

In terms of safety, no new safety signals were identified. The incidence of serious adverse events (SAEs) was 39.9%, slightly lower than the 40.4% in the control group. 

References：
[1] Yi M, Jiao D, Qin S, Chu Q, Wu K, Li A. Synergistic effect of immune checkpoint blockade and anti-angiogenesis in cancer treatment. Mol Cancer. 2019;18(1):60. doi:10.1186/s12943-019-0974-6
[2] Yuankai Shi, et al. 2025 ASCO; Abstract 8514.

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