A novel anti-PD-1 antibody HLX10 study led to the initiation of combination immunotherapy

Chao, Tsu Yi; Ho, C.L.; Cheng, Wun Hao; Chang, Che‐Mai; Hsieh, Yao Yu; Jiang, Weidong; Liu, S.; Luk, Alvin; Lin, Shitong; Hsieh, T’sang‐T’ang; Liu, E.

doi:10.1093/annonc/mdz438.007

Cited by 5 publications

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“…Serplulimab (formerly HLX10) is a fully humanized IgG 4 monoclonal antibody against the PD-1 receptor. In a phase 1 trial, up to 10 mg/kg of serplulimab was well tolerated and demonstrated similar pharmacokinetic characteristics to pembrolizumab and nivolumab . Serplulimab showed antitumor activity and a manageable adverse event profile for a variety of cancers in phase 2 clinical trials .…”

Section: Introductionmentioning

confidence: 96%

“…In a phase 1 trial, up to 10 mg/kg of serplulimab was well tolerated and demonstrated similar pharmacokinetic characteristics to pembrolizumab and nivolumab. 13 Serplulimab showed antitumor activity and a manageable adverse event profile for a variety of cancers in phase 2 clinical trials. 14,15 The ASTRUM-005 trial aimed to evaluate the efficacy and adverse event profile of PD-1 inhibitor serplulimab plus chemotherapy vs placebo plus chemotherapy in patients with extensive-stage SCLC who had not previously received systemic therapy.…”

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confidence: 99%

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Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer

Cheng

Liang

et al. 2022

JAMA

169

120

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ImportanceProgrammed cell death ligand 1 inhibitors combined with chemotherapy has changed the approach to first-line treatment in patients with extensive-stage small cell lung cancer (SCLC). It remained unknown whether adding a programmed cell death 1 (PD-1) inhibitor to chemotherapy provided similar or better benefits in patients with extensive-stage SCLC, which would add evidence on the efficacy of checkpoint inhibitors in the treatment of extensive-stage SCLC.ObjectiveTo evaluate the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with extensive-stage SCLC.Design, Setting, and ParticipantsThis international, double-blind, phase 3 randomized clinical trial (ASTRUM-005) enrolled patients at 114 hospital sites in 6 countries between September 12, 2019, and April 27, 2021. Of 894 patients who were screened, 585 with extensive-stage SCLC who had not previously received systemic therapy were randomized. Patients were followed up through October 22, 2021.InterventionsPatients were randomized 2:1 to receive either 4.5 mg/kg of serplulimab (n = 389) or placebo (n = 196) intravenously every 3 weeks. All patients received intravenous carboplatin and etoposide every 3 weeks for up to 12 weeks.Main Outcomes and MeasuresThe primary outcome was overall survival (prespecified significance threshold at the interim analysis, 2-sided P &lt; .012). There were 13 secondary outcomes, including progression-free survival and adverse events.ResultsAmong the 585 patients who were randomized (mean age, 61.1 [SD, 8.67] years; 104 [17.8%] women), 246 (42.1%) completed the trial and 465 (79.5%) discontinued study treatment. All patients received study treatment and were included in the primary analyses. As of the data cutoff (October 22, 2021) for this interim analysis, the median duration of follow-up was 12.3 months (range, 0.2-24.8 months). The median overall survival was significantly longer in the serplulimab group (15.4 months [95% CI, 13.3 months-not evaluable]) than in the placebo group (10.9 months [95% CI, 10.0-14.3 months]) (hazard ratio, 0.63 [95% CI, 0.49-0.82]; P &lt; .001). The median progression-free survival (assessed by an independent radiology review committee) also was longer in the serplulimab group (5.7 months [95% CI, 5.5-6.9 months]) than in the placebo group (4.3 months [95% CI, 4.2-4.5 months]) (hazard ratio, 0.48 [95% CI, 0.38-0.59]). Treatment-related adverse events that were grade 3 or higher occurred in 129 patients (33.2%) in the serplulimab group and in 54 patients (27.6%) in the placebo group.Conclusions and RelevanceAmong patients with previously untreated extensive-stage SCLC, serplulimab plus chemotherapy significantly improved overall survival compared with chemotherapy alone, supporting the use of serplulimab plus chemotherapy as the first-line treatment for this patient population.Trial RegistrationClinicalTrials.gov Identifier: NCT04063163

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Section: Introductionmentioning

confidence: 96%

mentioning

confidence: 99%

Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer

Cheng

Liang

et al. 2022

JAMA

169

120

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“…Serplulimab (HLX10) is a novel humanised monoclonal anti-PD-1 antibody. In a phase I study involving patients with previously treated advanced or metastatic solid tumours (NCT03468751), serplulimab up to 10 mg/kg was safe and well tolerated [ 18 ]. Here we present data from a phase II study evaluating the antitumour activity and safety of serplulimab 3 mg/kg in Chinese patients with unresectable or metastatic MSI-H/dMMR solid tumours in the subsequent line setting.…”

Section: Introductionmentioning

confidence: 99%

Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial

Qin

Huang

et al. 2022

Br J Cancer

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Background Microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) tumours have a high response rate to immunotherapy. Antitumour activity and safety of serplulimab, a novel humanised anti-PD-1 monoclonal antibody, were evaluated in this phase II study. Methods In this ongoing, single-arm, open-label, phase II trial, patients with previously treated unresectable or metastatic MSI-H/dMMR solid tumours received intravenous serplulimab 3 mg/kg every 2 weeks for up to 52 cycles. The primary endpoint was objective response rate (ORR) assessed by an independent radiological review committee per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included additional efficacy measures, safety, and tolerability. Results As of 9 January 2021, 108 patients were enrolled, and 68 patients with confirmed MSI-H solid tumours were included in the main efficacy analysis population (MEAP). The median follow-up duration in the MEAP was 7.7 months, with an ORR of 38.2% (95% confidence interval, 26.7–50.8). Of the 108 patients, grade ≥3 treatment-emergent adverse events were reported in 53 (49.1%) patients; immune-related adverse events occurred in 52 (48.1%) patients. Conclusions Serplulimab demonstrates a durable antitumour effect and a manageable safety profile in previously treated patients with MSI-H solid tumours. Serplulimab is a promising tissue-agnostic treatment for previously treated MSI-H solid tumours. Trial registration NCT03941574.

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Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study

Ho,

Chao,

Chang

et al. 2024

BioDrugs

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A novel anti-PD-1 antibody HLX10 study led to the initiation of combination immunotherapy

Cited by 5 publications

References 0 publications

Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer

Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer

Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial

Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study

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