On February 14, Benmelstobart Injection (Andewei^®), a Class 1 new drug from CTTQ Pharma, a core enterprise of Sino Biopharmaceutical Limited (1177.HK), was approved by the National Medical Products Administration (NMPA). It is indicated for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) who do not have known epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements and whose disease has not progressed following platinum-based concurrent or sequential radiochemotherapy. This is the 4th indication approved for Benmelstobart, providing new evidence for the long-term value of synergistic radiochemotherapy and immunotherapy in the Chinese population. 

This approval is based on the positive results of the R-ALPS study. The study enrolled patients with locally advanced/unresectable Stage III NSCLC whose disease had not progressed after concurrent/sequential radiochemotherapy. Among them, 129 patients received Benmelstobart consolidation therapy, and 132 patients received placebo until disease progression. The primary endpoint was progression-free survival (PFS) as assessed by a Blinded Independent Central Review (BICR). 

Study results^[1] showed:

● With a median follow-up of 19.4 months, the median PFS for patients receiving Benmelstobart consolidation therapy was 9.69 months, compared to 4.17 months in the placebo group (HR=0.53, 95% CI 0.39-0.72, P<0.0001), representing a 47% reduction in the risk of disease progression or death; 

● Pre-specified subgroup analyses (smoking status, prior treatment modality of concurrent/sequential) showed a benefit trend consistent with the ITT population, demonstrating the broad applicability of this treatment regimen; 

● Overall survival (OS) data were not yet mature, and the median OS has not been reached. The hazard ratio between the two groups was HR=0.76 (0.50, 1.14), with the Benmelstobart consolidation therapy group already showing a trend towards OS benefit; 

● In terms of safety, the incidence of grade ≥3 treatment-related adverse events was (29.4% vs. 19.7%), ensuring compliance for long-term treatment. 

Globally, lung cancer remains the neoplasm malignant with the highest incidence and mortality rates. In 2022, there were 2.48 million new cases of lung cancer globally and 1.061 million in China. NSCLC accounted for approximately 80%-85% of these cases, with about 30% of patients diagnosed at a locally advanced or metastatic stage^[2,3]. Benmelstobart is the third PD-L1 inhibitor in the world, following durvalumab and sugemalimab, to be marketed for consolidation therapy after definitive radiochemotherapy for locally advanced/unresectable NSCLC. 

Currently, Benmelstobart has been approved for 4 indications in China. Previously approved indications include combination therapy with Anlotinib (Defu combination) for the first-line treatment of extensive-stage small cell lung cancer, recurrent or endometrial cancer metastatic, and first-line treatment of advanced unresectable or metastatic renal cell carcinoma. In addition, two other indications are currently under review for marketing approval: combination therapy with Anlotinib (Defu combination) for the first-line treatment of squamous NSCLC, and for the treatment of advanced or unresectable alveolar soft tissue sarcoma. 

References:

[1] Ming Chen, Yongling Ji, Long Chen, et al.R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.2025American Society of Clinical Oncology (ASCO) ( ). 

[2] Antonia SJ, Villegas A, Daniel D, et al.Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.N Engl J Med. 2017;377(20):1919-1929.

[3]  Qing Zhou,Ming Chen,et al.Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced, unresectable, stage III non-small-cell lung cancer in China (GEMSTONE-301): interim results of a randomised, double-blind, multicentre, phase 3 trial.The Lancet Oncology.2022;2(23).P209-219.

Disclaimer:

1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 

2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific information about disease diagnosis and treatment, please follow the advice or guidance of a doctor or other healthcare professional. 

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