Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial
Introduction: The study (ClinicalTrials.gov, NCT04346914) is an open label, single-arm, phase 1b clinical trial investigating the safety, tolerability, and efficacy of the recombinant human anti–programmed death-ligand 1 monoclonal antibody socazolimab in combination with carboplatin and etoposide i...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-04-01
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| Series: | JTO Clinical and Research Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666364323000176 |
| _version_ | 1827957225076817920 |
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| author | Shun Lu, PhD, MD Zhiwei Chen, MD Jiuwei Cui, MD Renhua Guo, MD Ziming Li, MD Benjamin Xiaoyi Li, PhD Xiangrong Dai, PhD |
| author_facet | Shun Lu, PhD, MD Zhiwei Chen, MD Jiuwei Cui, MD Renhua Guo, MD Ziming Li, MD Benjamin Xiaoyi Li, PhD Xiangrong Dai, PhD |
| author_sort | Shun Lu, PhD, MD |
| collection | DOAJ |
| description | Introduction: The study (ClinicalTrials.gov, NCT04346914) is an open label, single-arm, phase 1b clinical trial investigating the safety, tolerability, and efficacy of the recombinant human anti–programmed death-ligand 1 monoclonal antibody socazolimab in combination with carboplatin and etoposide in the first-line treatment of extensive-stage SCLC. Good safety and efficacy were found in previous phase 1 clinical trials of other cancers, such as cervix cancer. Methods: Patients received socazolimab (5 mg/kg) every three weeks until disease progression or physician decision. Carboplatin (area under the curve: 5) was also administered every three weeks and etoposide (100 mg/m2) on days 1, 2, and 3 of the treatment cycle. The primary purpose of the study was safety measured by the Common Terminology Criteria for Adverse Events. Secondary purposes included objective response rate, progression-free survival, duration of response, and overall survival. Results: From April 15, 2020 (enrollment date), to December 30, 2021 (data cutoff), 20 patients with extensive-stage SCLC were administered with socazolimab, carboplatin, and etoposide. Objective response rate was 70.0% (95% confidence interval [CI]: 45.72%–88.11%). Median progression-free survival was 5.65 months (95% CI: 4.14–6.54), and the median duration of response was 4.29 months (95% CI: 2.76–5.85). Median overall survival was 14.88 months (95% CI: 10.09–not evaluated). The highest incidence of treatment-related adverse events included anemia (100%), decreased neutrophil count (95%), decreased platelet count (95%), and decreased white blood cell count (95%), which occurred during combination therapy. The most common grade 3 or 4 treatment-related adverse events were neutropenia (90%), decreased white blood cell count (65%), decreased platelet count (50%), and anemia (30%), which were also common adverse reactions of chemotherapy. No adverse events leading to death had occurred. Conclusions: Results revealed that the combination therapy of socazolimab, carboplatin, and etoposide had preliminarily confirmed the safety of socazolimab in the first-line treatment of SCLC combined with EC chemotherapy. Currently, a phase 3, randomized, placebo-controlled trial (ClinicalTrials.gov, NCT04878016) is being conducted with 498 patients. |
| first_indexed | 2024-04-09T15:15:53Z |
| format | Article |
| id | doaj.art-32d4080e546746b8a96ff2bcd272221d |
| institution | Directory Open Access Journal |
| issn | 2666-3643 |
| language | English |
| last_indexed | 2024-04-09T15:15:53Z |
| publishDate | 2023-04-01 |
| publisher | Elsevier |
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| series | JTO Clinical and Research Reports |
| spelling | doaj.art-32d4080e546746b8a96ff2bcd272221d2023-04-29T14:58:45ZengElsevierJTO Clinical and Research Reports2666-36432023-04-0144100478Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical TrialShun Lu, PhD, MD0Zhiwei Chen, MD1Jiuwei Cui, MD2Renhua Guo, MD3Ziming Li, MD4Benjamin Xiaoyi Li, PhD5Xiangrong Dai, PhD6Department of Oncology, Shanghai Chest Hospital, Shanghai, People’s Republic of China; Corresponding author. Address for correspondence: Shun Lu, PhD, MD, Department of Oncology, Shanghai Chest Hospital, 241 West Huaihai Road, Shanghai 200030, People’s Republic of China.Department of Oncology, Shanghai Chest Hospital, Shanghai, People’s Republic of ChinaDepartment of Oncology, First Hospital of Jilin University, Changchun, People’s Republic of ChinaDepartment of Oncology, Jiangsu Provincial People’s Hospital, Nanjing, People’s Republic of ChinaDepartment of Oncology, Shanghai Chest Hospital, Shanghai, People’s Republic of ChinaLee’s Pharmaceutical Holdings Limited, Shatin, Hong Kong, People’s Republic of ChinaLee’s Pharmaceutical Holdings Limited, Shatin, Hong Kong, People’s Republic of ChinaIntroduction: The study (ClinicalTrials.gov, NCT04346914) is an open label, single-arm, phase 1b clinical trial investigating the safety, tolerability, and efficacy of the recombinant human anti–programmed death-ligand 1 monoclonal antibody socazolimab in combination with carboplatin and etoposide in the first-line treatment of extensive-stage SCLC. Good safety and efficacy were found in previous phase 1 clinical trials of other cancers, such as cervix cancer. Methods: Patients received socazolimab (5 mg/kg) every three weeks until disease progression or physician decision. Carboplatin (area under the curve: 5) was also administered every three weeks and etoposide (100 mg/m2) on days 1, 2, and 3 of the treatment cycle. The primary purpose of the study was safety measured by the Common Terminology Criteria for Adverse Events. Secondary purposes included objective response rate, progression-free survival, duration of response, and overall survival. Results: From April 15, 2020 (enrollment date), to December 30, 2021 (data cutoff), 20 patients with extensive-stage SCLC were administered with socazolimab, carboplatin, and etoposide. Objective response rate was 70.0% (95% confidence interval [CI]: 45.72%–88.11%). Median progression-free survival was 5.65 months (95% CI: 4.14–6.54), and the median duration of response was 4.29 months (95% CI: 2.76–5.85). Median overall survival was 14.88 months (95% CI: 10.09–not evaluated). The highest incidence of treatment-related adverse events included anemia (100%), decreased neutrophil count (95%), decreased platelet count (95%), and decreased white blood cell count (95%), which occurred during combination therapy. The most common grade 3 or 4 treatment-related adverse events were neutropenia (90%), decreased white blood cell count (65%), decreased platelet count (50%), and anemia (30%), which were also common adverse reactions of chemotherapy. No adverse events leading to death had occurred. Conclusions: Results revealed that the combination therapy of socazolimab, carboplatin, and etoposide had preliminarily confirmed the safety of socazolimab in the first-line treatment of SCLC combined with EC chemotherapy. Currently, a phase 3, randomized, placebo-controlled trial (ClinicalTrials.gov, NCT04878016) is being conducted with 498 patients.http://www.sciencedirect.com/science/article/pii/S2666364323000176SocazolimabExtensive-stage small cell lung cancer (ES-SCLC)CarboplatinEtoposidePD-L1 |
| spellingShingle | Shun Lu, PhD, MD Zhiwei Chen, MD Jiuwei Cui, MD Renhua Guo, MD Ziming Li, MD Benjamin Xiaoyi Li, PhD Xiangrong Dai, PhD Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial JTO Clinical and Research Reports Socazolimab Extensive-stage small cell lung cancer (ES-SCLC) Carboplatin Etoposide PD-L1 |
| title | Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial |
| title_full | Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial |
| title_fullStr | Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial |
| title_full_unstemmed | Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial |
| title_short | Efficacy and Safety of Anti–Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial |
| title_sort | efficacy and safety of anti programmed death ligand 1 monoclonal antibody socazolimab with carboplatin and etoposide for extensive stage sclc results from the phase 1b clinical trial |
| topic | Socazolimab Extensive-stage small cell lung cancer (ES-SCLC) Carboplatin Etoposide PD-L1 |
| url | http://www.sciencedirect.com/science/article/pii/S2666364323000176 |
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