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The ASTRUM-005 trial (NCT04063163) revealed that combination serplulimab plus chemotherapy (etoposide and carboplatin [EC]) treatment was associated with survival advantages relative to chemotherapy alone in patients diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). As these immuno-chemotherapeutic regimens are extremely expensive, however, it is critical that the relative cost-effectiveness of combination serplulimab and chemotherapy treatment as a first-line treatment for ES-SCLC patients be examined in detail. The cost-effectiveness of combined serplulimab plus chemotherapeutic treatment was examined using a comprehensive Markov model with a 10-year boundary, enabling the calculation of overall cost, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). Model instability was interrogated through one-way and probabilistic sensitivity analyses. Serplulimab plus chemotherapy or chemotherapy alone respectively yielded 1.217 QALYs (2.243 LYs) and 0.885 QALYs (1.661 LYs) with corresponding total costs of $11,202 and $7,194, with an ICER of $12,077 per QALY ($6,883 per LY). This model was most strongly influenced by the utility of progression-free survival. Probabilistic sensitivity analysis showed that serplulimab plus chemotherapy had a 91.6% probability of being cost-effective at a willingness-to-pay (WTP) of $37,653 per QALY (3 × capita gross domestic product of China in 2021). In subgroup analyses, this combination treatment regimen was found to be most cost-effective in patients who were former smokers, had an ECOG performance status of 0, and were diagnosed with brain metastases. From a payer perspective in China, combination serplulimab plus chemotherapy treatment represents a cost-effective first-line intervention for ES-SCLC patients.

Immune checkpoint inhibitors targeting the PD-1/PD-L1 axis, in combination with platinum-based chemotherapy, have become the standard first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Among these agents, serplulimab is a PD-1 inhibitor, while adebrelimab, durvalumab, and atezolizumab are PD-L1 inhibitors, all of which have been integrated into clinical practice based on emerging evidence. However, the comparative efficacy of these combined therapies remains unclear. This study aims to compare the efficacy of Serplulimab, Adebrelimab, Durvalumab, and Atezolizumab when combined with chemotherapy, providing real-world data on their clinical benefits in ES-SCLC. This retrospective study included 322 patients diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) who received first-line treatment with platinum-based chemotherapy combined with a PD-1 or PD-L1 immune checkpoint inhibitor between March 2019 and December 2023. The primary endpoints were overall survival (OS)and progression-free survival (PFS). A total of 322 patients with extensive-stage small-cell lung cancer (ES-SCLC) were enrolled in this study. All patients received chemotherapy in combination with one of the following PD-L1 inhibitors: Adebrelimab (n = 71), Serplulimab (n = 80), Durvalumab (n = 93), or Atezolizumab (n = 78).The median PFS was 7.63 months (95% CI 6.57–8.77) for Atezolizumab, 6.9 months (95% CI 5.67–8.57) for Serplulimab, 7.43 months (95% CI 6.3–9.43) for Durvalumab, and 7.4 months (95% CI 6.3–9.43) for Adebrelimab. No significant differences in PFS were observed between Serplulimab and the other PD-L1 inhibitors, with p values of 0.96 for Adebrelimab, 0.8 for Atezolizumab, and 0.44 for Durvalumab.The median OS was 17.2 months (95% CI 13.3–27.7) for Atezolizumab, 15.0 months (95% CI 12.8–NA) for Serplulimab, 17.6 months (95% CI 16.2–26.6) for Durvalumab, and 23.2 months (95% CI 23.1–NA) for Adebrelimab. No significant differences in OS were observed between Serplulimab and either Durvalumab ( p  = 0.23) or Atezolizumab ( p  = 0.61). However, Adebrelimab was associated with a significantly longer OS compared to Serplulimab ( p  = 0.029). Multivariate Cox regression analysis revealed that liver metastasis was an independent adverse prognostic factor for both PFS and OS. The combination of chemotherapy with PD-1 and PD-L1 inhibitors, including Serplulimab, Adebrelimab, Durvalumab, and Atezolizumab, demonstrates comparable efficacy regarding PFS. However, Adebrelimab provides a significantly better long-term survival benefit, indicating its potential as a superior treatment option for extensive-stage small cell lung cancer (ES-SCLC).

ObjectiveThe ASTRUM-005 trial demonstrated that adding serplulimab to chemotherapy significantly prolonged the survival of patients with extensive-stage small cell lung cancer (SCLC), but also increased the risk of adverse events. Given the high cost of serplulimab compared to chemotherapy, this study aimed to evaluate the cost-effectiveness of serplulimab plus chemotherapy as a first-line treatment for extensive-stage SCLC from the perspective of China’s healthcare system.MethodsA Markov model was developed to simulate the disease process of extensive-stage SCLC and estimate the health outcomes and direct medical costs of patients. Scenario analyses, univariate sensitivity analyses, and probabilistic sensitivity analyses were conducted to explore the impact of different parameters on model uncertainty. The primary model outcomes included costs, life-years (LYs), quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER).ResultsCompared to placebo plus chemotherapy, serplulimab plus chemotherapy resulted in an additional 0.25 life-years and 0.15 QALYs, but also increased costs by $26,402, resulting in an ICER of 179,161 USD/QALY. Sensitivity analysis showed that the ICER was most sensitive to the cost of serplulimab, and the probability that serplulimab was cost-effective when added to chemotherapy was only 0 at the willingness-to-pay threshold of 37,423 USD/QALY. Scenario analysis revealed that price discounts on serplulimab could increase its probability of being cost-effective.ConclusionSerplulimab 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.

BackgroundImmunochemotherapy is standard for small-cell lung cancer (SCLC), yet efficacy and safety of serplulimab for patients with brain metastases (BM) remain to be fully elucidated in routine clinical practice.MethodsIn this multicenter, prospective cohort study, SCLC patients with BM who received first-line serplulimab plus platinum-based chemotherapy or chemotherapy alone were included. Primary endpoint was intracranial progression-free survival (iPFS). Secondary endpoints included extracranial PFS, systemic PFS, overall survival (OS), tumor response, and safety.ResultsA total of 62 patients with SCLC and confirmed BM were included. Patients treated with serplulimab achieved an intracranial objective response rate of 78.57%. With a median follow-up of 22.17 months, serplulimab combined with chemotherapy demonstrated significant benefits across all survival outcomes. The serplulimab group demonstrated significantly prolonged median iPFS (8.93 vs. 6.37 months; log-rank P = 0.004) and OS (28.77 vs. 12.95 months; log-rank P < 0.001) compared with chemotherapy alone. Exploratory analyses revealed that the addition of cranial radiotherapy to immunotherapy significantly augmented survival benefits. Safety profiles were manageable, with no new safety signals identified.ConclusionFirst-line serplulimab plus chemotherapy demonstrates robust intracranial efficacy and survival benefits with manageable safety in SCLC patients with BM. Integrating cranial radiotherapy appears to offer complementary clinical value, supporting this multimodal strategy as a viable therapeutic option.

The present study compared the effectiveness and safety of immunotherapy retreatment with serplulimab vs. chemotherapy in extensive-stage small cell lung cancer (ES-SCLC). This real-world retrospective cohort study included patients with ES-SCLC who experienced failed first-line immunotherapy and received second-line immunotherapy retreatment (serplulimab) or chemotherapy. There were 67 and 93 patients in the serplulimab and chemotherapy groups, respectively. Progression-free survival (PFS) time was prolonged with the administration of serplulimab compared with chemotherapy [median, 7.65 vs. 5.25 months; hazard ratio (HR), 0.601; 95% confidence interval (CI), 0.426-0.848; P=0.003]; the results were similar after confounder adjustment in the multivariable Cox regression analysis (HR, 0.572; 95% CI, 0.395-0.828; P=0.003). The median overall survival (OS) time was 15.56 vs. 13.48 months (HR, 0.680; 95% CI, 0.478-0.966; P=0.031). Multivariable Cox regression analysis showed that serplulimab was also an independent protective factor for OS compared with chemotherapy (HR, 0.158; 95% CI, 0.096-0.261; P<0.001). The incidence of grade ≥3 adverse events was 29.9 and 34.4% with serplulimab and chemotherapy, respectively (P=0.760). In conclusion, immunotherapy retreatment with serplulimab is associated with prolonged PFS and OS times compared with chemotherapy in ES-SCLC, with a similar safety profile.

We report the efficacy and safety of serplulimab, a novel humanized anti-programmed death-1 antibody, plus nanoparticle albumin-bound (nab)-paclitaxel in previously treated patients with programmed death ligand-1 (PD-L1)-positive advanced cervical cancer. Patients diagnosed with PD-L1-positive (combined positive score ≥1) cervical cancer were enrolled in this single-arm, open-label, phase II study. They were given serplulimab 4.5 mg/kg for up to 2 years (35 dosing cycles) plus nab-paclitaxel 260 mg/m for up to six cycles once every 3 weeks. Primary endpoints were safety and objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST version 1.1. Secondary endpoints included ORR assessed by the investigator, duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Between December 2019 and June 2020, 52 patients were screened and 21 were enrolled. IRRC-assessed ORR was 57.1% (95% confidence interval [CI] 34.0-78.2%); 3 (14.3%) patients achieved complete response and 9 (42.9%) partial response. The median DOR was not reached (NR) (95% CI 4.1-NR). IRRC-assessed median PFS was 5.7 months (95% CI 3.0-NR), and median OS was 15.5 months (95% CI 10.5-NR). Investigator-assessed ORR was 47.6% (95% CI 25.7-70.2%). Seventeen (81.0%) patients experienced grade ≥3 treatment-emergent adverse events. Grade ≥3 adverse drug reactions were reported in 7 (33.3%) patients. Immune-related adverse events occurred in 12 (57.1%) patients. In previously treated patients with PD-L1-positive advanced cervical cancer, serplulimab plus nab-paclitaxel provided durable clinical activity and a manageable safety profile. ClinicalTrials.gov, identifier NCT04150575.

IntroductionPancreatic cancer remains a leading cause of death with poor prognosis. Current standard chemotherapies offer limited survival benefits, and no standard treatment exists for patients failing two lines of therapy. Preclinical evidence suggests that targeting MNK and VEGFR pathways can remodel the immunosuppressive tumor microenvironment and enhance immunotherapy efficacy. This study evaluates the safety and efficacy of JDB153 (an MNK/VEGFR inhibitor) combined with serplulimab (an anti-PD-L1 antibody) in refractory advanced pancreatic cancer.Methods and analysisThis is a prospective, open-label, single-center, phase Ib/II clinical trial (NCT07175389). It will enroll patients with advanced pancreatic adenocarcinoma who have progressed after standard therapies. The study follows a Simon’s two-stage design. The initial phase will enroll 10 patients to test safety and preliminary efficacy. Patients will receive oral JDB153 and intravenous serplulimab. If at least one patient responds, the study will expand to a total of 32 patients. The primary endpoints are safety and ORR. Secondary endpoints include DFS, OS, and PFS. Safety will be graded using NCI-CTCAE version 5.0. Comprehensive biomarker analyses (PD-L1 expression, spatial immune profiling, next-generation sequencing, et al.) are integrated.DiscussionPatients with advanced pancreatic cancer need effective options that are less toxic than chemotherapy. Immunotherapy alone often fails in this disease due to the immunosuppressive microenvironment. By combining MNK/VEGFR inhibition with PD-1 blockade, this study investigates a promising strategy to overcome immune resistance and establish a novel treatment paradigm for advanced pancreatic adenocarcinoma.

Introduction This study aimed to evaluate the safety and preliminary efficacy of serplulimab, a novel programmed death-1 inhibitor, with or without bevacizumab biosimilar HLX04 as first-line treatment in patients with advanced hepatocellular carcinoma. Methods This open-label, multicenter phase 2 study (clinicaltrials.gov identifier NCT03973112) was conducted in China and consisted of four treatment groups: group A (serplulimab 3 mg/kg plus HLX04 5 mg/kg, subsequent-line), group B (serplulimab 3 mg/kg plus HLX04 10 mg/kg, subsequent-line), group C (serplulimab 3 mg/kg, subsequent-line) and group D (serplulimab 3 mg/kg plus HLX04 10 mg/kg, first-line). Group D was the only group in which participants received the study treatment in the first-line setting. The primary endpoint was safety. Results Following previous report on groups A and B, results of group D are herein presented. As of February 7, 2023, 61 patients were enrolled and were followed up for a median of 25.5 months. Grade ≥ 3 treatment-emergent adverse events were reported by 29 (47.5%) patients. One patient died from adverse events that were considered related to study treatment. Among the patients with at least one post-baseline tumor assessment (n = 58), the objective response rate was 29.3% (95% CI: 18.1–42.7) as assessed by an independent radiological review committee (IRRC) per RECIST v1.1. IRRC-assessed median progression-free survival was 7.3 months (95% CI: 2.8–11.0), and median overall survival was 20.4 months (95% CI: 15.0–NE), respectively. Conclusion Serplulimab combination therapy with HLX04 showed a manageable safety profile as well as preliminary efficacy in patients with advanced HCC in the first-line setting.

To determine the cost-effectiveness of imported immune checkpoint inhibitors (ICIs) such as atezolizumab and durvalumab, and domestic ICIs like serplulimab and adebrelimab, in combination with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC) in China. Using a 21-day cycle length and a 20-year time horizon, a Markov model was established to compare the clinical and economic outcomes of five first-line ICIs plus chemotherapy versus chemotherapy alone, as well as against each other, from the perspective of the Chinese healthcare system. Transition probabilities were estimated by combining the results of the CAPSTONE-1 trial and a published network meta-analysis. Cost and health state utilities were collected from multiple sources. Both cost and effectiveness outcomes were discounted at a rate of 5% annually. The primary model output was incremental cost-effectiveness ratios (ICERs). A series of sensitivity analyses were preformed to assess the robustness of the model. In the base-case analysis, the addition of first-line ICIs to chemotherapy resulted in the ICERs ranged from $80,425.31/QALY to $812,415.46/QALY, which exceeded the willing-to-pay threshold set for the model. When comparing these first-line immunochemotherapy strategies, serplulimab plus chemotherapy had the highest QALYs of 1.51286 and the second lowest costs of $60,519.52, making it is the most cost-effective strategy. Our subgroup-level analysis yielded results that are consistent with the base-case analysis. The sensitivity analysis results confirmed the validity and reliability of the model. In China, the combination of fist-line ICIs plus chemotherapy were not considered cost-effective when compared to chemotherapy alone. However, when these fist-line immunochemotherapy strategies were compared with each other, first-line serplulimab plus chemotherapy consistently demonstrated superiority in terms of cost-effectiveness. Reducing the cost of serplulimab per 4.5 mg/kg would be a realistic step towards making first-line serplulimab plus chemotherapy more accessible and cost-effective.