Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Wang, Jie; Zhou, Caicun; Yao, Wenxiu; Wang, Qiming; Min, Xuhong; Chen, Gongyan; Xu, Xiaowei; Li, Xingya; Xu, Fei; Fang, Yong; Yang, Runxiang; Yu, Guohua; Gong, Youling; Zhao, Jun; Fan, Yun; Liu, Quan; Cao, Lejie; Yao, Yu; Liu, Yunpeng; Li, Xiaoling; Wu, Jingxun; Zhou, He; Lu, Kaihua; Jiang, Liyan; Hu, Chengping; Zhao, Wenhua; Zhang, Ben; We, Shi; Zhang, Xiaojing; Cheng, Ying

doi:10.1016/s1470-2045(22)00224-8

Cited by 162 publications

(179 citation statements)

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“…On the other hand, the anticipation of immunotherapy to first line makes even more urgent the research on effective second-line strategies, since the modest results of topotecan may be even more negligible after chemo-immunotherapy, and one patient out of two would need at least one further line of treatment, as demonstrated in several phase 3 trials investigating EP plus immunotherapy [ 13 , 15 , 17 , 19 ]. In Europe, two options are available for first line treatment of ES-SCLC with similar schedules (atezolizumab and durvalumab) that have demonstrated similar efficacy and safety profiles.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, a Chinese phase 3 trial of first line chemo-immunotherapy was recently published [ 19 ]. The experimental treatment consisted of a combination of carboplatin and etoposide with adebrelimab (a novel anti-PD-L1 agent).…”

Section: The Establishment Of a New First-line Standardmentioning

confidence: 99%

“…Chemotherapy was administered together with adebrelimab for four to six cycles, followed by adebrelimab maintenance. OS was significantly improved by adebrelimab (mOS 15.3 vs. 12.8 months [HR 0.72 95% CI 0.58–0.90]; p = 0.0017), with an acceptable safety profile [ 19 ]. Notably, hematological adverse events were the most common in both groups, suggesting that they were mainly related to chemotherapy.…”

Section: The Establishment Of a New First-line Standardmentioning

confidence: 99%

“…In particular, grade 3–4 neutropenia was reported in 76% of patients, while anemia and platelet count decrease were mainly of grade 1–2 (57% and 45%, respectively). With the limitations of comparison among different studies, hematological toxicity rates were higher than those reported in the CASPIAN and Impower133 trials, probably due to the possibility of administering more cycles of chemotherapy in the Capstone-1 study (median number of cycles was six in both arms) [ 19 ].…”

Section: The Establishment Of a New First-line Standardmentioning

confidence: 99%

“…Unlike for NSCLC, PD-L1 expression is indeed typically low or absent in SCLC, and its use as a predictive biomarker is limited [ 81 ]. In phase 3 trials of chemotherapy plus PD-(L)1 checkpoint inhibitors, a survival benefit was observed across different PD-L1 subgroups, and thus in clinical practice ICIs can be administered for ES-SCLC regardless of PD-L1 status [ 13 , 15 , 17 , 19 ].…”

Section: Chasing Predictive Biomarkers For Sclc Immunotherapymentioning

confidence: 99%

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Dissecting Immunotherapy Strategies for Small Cell Lung Cancer: Antibodies, Ionizing Radiation and CAR-T

Guaitoli

Neri

Cabitza

et al. 2022

IJMS

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Small cell lung cancer (SCLC) is a highly aggressive malignancy that accounts for about 14% of all lung cancers. Platinum-based chemotherapy has been the only available treatment for a long time, until the introduction of immune checkpoint inhibitors (ICIs) recently changed first-line standard of care and shed light on the pivotal role of the immune system. Despite improved survival in a subset of patients, a lot of them still do not benefit from first-line chemo-immunotherapy, and several studies are investigating whether different combination strategies (with both systemic and local treatments, such as radiotherapy) may improve patient outcomes. Moreover, research of biomarkers that may be used to predict patients’ outcomes is ongoing. In addition to ICIs, immunotherapy offers other different strategies, including naked monoclonal antibodies targeting tumor associated antigens, conjugated antibody, bispecific antibodies and cellular therapies. In this review, we summarize the main evidence available about the use of immunotherapy in SCLC, the rationale behind combination strategies and the studies that are currently ongoing in this setting, in order to give the reader a clear and complete view of this rapidly expanding topic.

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Section: Discussionmentioning

confidence: 99%

Section: The Establishment Of a New First-line Standardmentioning

confidence: 99%

Section: The Establishment Of a New First-line Standardmentioning

confidence: 99%

Section: The Establishment Of a New First-line Standardmentioning

confidence: 99%

Section: Chasing Predictive Biomarkers For Sclc Immunotherapymentioning

confidence: 99%

See 3 more Smart Citations

Dissecting Immunotherapy Strategies for Small Cell Lung Cancer: Antibodies, Ionizing Radiation and CAR-T

Guaitoli

Neri

Cabitza

et al. 2022

IJMS

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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

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164

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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Advances in immune checkpoint inhibitors therapy for small cell lung cancer

Liang

et al. 2023

Cancer Medicine

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According to the latest National Cancer Center of China data, lung cancer is the most frequent tumor in China with a high incidence and fatality rate. 1 Small cell lung cancer (SCLC) was one of the most dangerous subtypes of lung cancer, accounting for about 15%-20% of all cases. 2 Tobacco use was strongly connected to the development of SCLC, and there is evidence that the mutational nature of SCLC has a distinct smoking profile. 3 Almost all patients have a smoking history, and only 2% of SCLC patients do not smoke. 4 SCLC increases more rapidly, is

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Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Cited by 162 publications

References 19 publications

Dissecting Immunotherapy Strategies for Small Cell Lung Cancer: Antibodies, Ionizing Radiation and CAR-T

Dissecting Immunotherapy Strategies for Small Cell Lung Cancer: Antibodies, Ionizing Radiation and CAR-T

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

Advances in immune checkpoint inhibitors therapy for small cell lung cancer

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