Hansizhuang (serplulimab)

P1, N=162, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.

P2, N=37, Recruiting, Zhejiang Cancer Hospital

P2, N=61, Recruiting, Sichuan University | Not yet recruiting --> Recruiting

P2, N=35, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P1, N=20, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Aug 2025 | Trial primary completion date: Feb 2024 --> Dec 2024

P2, N=50, Recruiting, The First Affiliated Hospital with Nanjing Medical University

P2, N=117, Not yet recruiting, Shanghai Henlius Biotech

P2, N=100, Recruiting, Zhejiang Cancer Hospital

P1, N=23, Recruiting, Guangzhou FineImmune Biotechnology Co., LTD.

P2, N=96, Not yet recruiting, Peking Union Medical College Hospital

P2/3, N=152, Recruiting, Sun Yat-sen University

P2, N=132, Recruiting, Shanghai Henlius Biotech | N=60 --> 132

P2, N=55, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2025 --> Jun 2024

Here, this is the first report on an unknown primary LCNEC patient who had achieved a long-term response from ICI treatment (atezolizumab), but developed HPD after tumor progression due to receiving another ICI agent (serplulimab). Patients with the aforementioned genes should caution when selecting ICI treatment. These findings required further confirmation in a larger study cohort.

P1, N=9, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed

P2, N=23, Active, not recruiting, Zhejiang Cancer Hospital

Compared with chemotherapy, serplulimab coupled with chemotherapy was not cost-effective for the treatment of advanced OSCC in China.

P=N/A, N=39, Not yet recruiting, Shanghai Changzheng Hospital

Compared to chemotherapy alone, serplulimab combined with chemotherapy is currently not a cost-effective first-line treatment for advanced/metastatic ESCC in China. However, as serplulimab plus chemotherapy regimens evolve and price competition among programmed death 1 (PD-1) inhibitors intensifies, this combination may become a cost-effective treatment option.

This study aims to provide valuable insights into the efficacy and safety of combining serplulimab with chemotherapy for treating patients with T-SCLC originating from EGFR-mutant NSCLC.

P2, N=53, Not yet recruiting, Sun Yat-sen University

Conclusions No new safety signals were observed for the different doses of HLX26 in combination with serplulimab. HLX26 plus serplulimab was safe and well tolerated in patients with advanced solid tumours who had failed or could not receive standard therapies.

Serplulimab plus chemotherapy was not cost-effective, despite having a prior clinical benefical and a relative safety profile compared with chemotherapy. With the reduction in the price of serplulimab, ES-SCLC patients treated with serplulimab plus chemotherapy may be able to achieve a favorable cost-effectiveness rate.

Serplulimab plus chemotherapy is not a cost-effective strategy for first-line treatment of extensive-stage SCLC in China. Price discounts on serplulimab can enhance its cost-effectiveness.

P2, N=60, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting

P1, N=6, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Aug 2023

Compared with chemotherapy, SEP was not cost-effective from the perspective of the Chinese healthcare system. However, SEP was absolutely dominant in comparison with AEP.

Incremental cost-effectiveness ratios of serplulimab therapy were found to exceed the willingness-to-pay threshold of $37,304.34. Thus, serplulimab is not cost-effective compared with chemotherapy as a first-line treatment for esophageal squamous cell carcinoma patients.

P2, N=49, Suspended, Shanghai Henlius Biotech | Recruiting --> Suspended

P3, N=537, Active, not recruiting, Shanghai Henlius Biotech | Trial completion date: Jan 2023 --> Dec 2023 | Trial primary completion date: Mar 2021 --> Dec 2023

P1, N=20, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting | N=11 --> 20 | Trial completion date: May 2024 --> Feb 2025 | Trial primary completion date: Sep 2023 --> Feb 2024

P3, N=643, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Oct 2023

P2, N=114, Recruiting, Fudan University

P2, N=36, Recruiting, Guangdong Association of Clinical Trials

P2, N=50, Not yet recruiting, Junjie Peng

P2, N=49, Recruiting, Zhejiang University | Not yet recruiting --> Recruiting

The regimens were ipilimumabnu (Ipi), atezolizumab (Atez), durvalumab plus tremelimumab (Durv-Trem), durvalumab (Durv), pembrolizumab (Pemb), adebrelimab (Adeb), serplulimab (Serp), atezolizumab plus tiragolumab (Atez-Tira), and nivolumab (Nivo). Certainly, more head-to-head studies are needed to confirm these findings. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022373291.

P2, N=107, Recruiting, Tianjin Medical University Cancer Institute and Hospital

Adebrelimab plus EP and serplulimab plus EP were probably cost-effective for ES-SCLC in China, and serplulimab plus EP was probably cost-effective for ES-SCLC in the U.S. Lowering the price of ICIs and selecting ES-SCLC patients who were sensitive to ICIs could improve the cost-effectiveness of the ICIs-combined treatment.

P2, N=49, Recruiting, Shanghai Henlius Biotech | Trial completion date: Nov 2023 --> Apr 2026 | Trial primary completion date: Aug 2023 --> Aug 2024

P2, N=35, Recruiting, Peking Union Medical College Hospital

The objective response rate was 30.0% (95% confidence interval [CI], 11.9-54.3) in group A and 14.3% (95% CI, 3.0-36.3) in group B. Median duration of response was not reached (95% CI, 3.3-not evaluable [NE]) in group A and was 9.0 months (95% CI, 7.9-NE) in group B. Median progression-free survival was 2.2 months (95% CI, 1.4-5.5) and 4.1 months (95% CI, 1.5-NE), and median overall survival was 11.6 months (95% CI, 6.4-NE) and 14.3 months (95% CI, 8.2-NE) in groups A and B, respectively. Serplulimab plus HLX04 showed a manageable safety profile and promising antitumor activity in patients with previously treated advanced HCC.