Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial
Abstract Background Combining the programmed death-1 inhibitor toripalimab and the angio-immuno kinase inhibitor surufatinib showed preliminary antitumor activity in patients with advanced solid tumors in a phase I study. Here, we report the efficacy and safety of this combination regimen in treatme...
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| Format: | Article |
| Language: | English |
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Springer
2025-02-01
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| Series: | Cancer Immunology, Immunotherapy |
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| Online Access: | https://doi.org/10.1007/s00262-024-03932-x |
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| _version_ | 1832571632597598208 |
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| author | Ying Cheng Panpan Zhang Ming Lu Zhendong Chen Lijie Song Si Shi Feng Ye Xing Zhang Baorui Liu Dongmei Ji Yanqiao Zhang Weiguo Su Michael Shi Songhua Fan Panfeng Tan Chen Zhong |
| author_facet | Ying Cheng Panpan Zhang Ming Lu Zhendong Chen Lijie Song Si Shi Feng Ye Xing Zhang Baorui Liu Dongmei Ji Yanqiao Zhang Weiguo Su Michael Shi Songhua Fan Panfeng Tan Chen Zhong |
| author_sort | Ying Cheng |
| collection | DOAJ |
| description | Abstract Background Combining the programmed death-1 inhibitor toripalimab and the angio-immuno kinase inhibitor surufatinib showed preliminary antitumor activity in patients with advanced solid tumors in a phase I study. Here, we report the efficacy and safety of this combination regimen in treatment-naive advanced or metastatic non-small-cell lung cancer (NSCLC) patients with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1% or greater (PD-L1-positive) and patients with previously treated small-cell lung cancer (SCLC). Methods This open-label, single-arm phase II study included patients with treatment-naive advanced or metastatic PD-L1-positive NSCLC or previously treated SCLC in China. Patients received surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every 3 weeks). Primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. Secondary endpoints included duration of response (DoR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety. Results Forty-three patients were treated (NSCLC cohort, n = 23; SCLC cohort, n = 20). ORRs (95% CIs) were 57.1% (34.0–78.2) in the NSCLC cohort and 15.8% (3.4–39.6) in the SCLC cohort. Median duration of response was not reached (NR) in both cohorts. Median PFS was 9.6 (5.5–NR) and 3.0 months (2.8–4.1), respectively, and median OS was 24.3 (10.8–NR) and 11.0 months (5.0–15.7), respectively. Grade ≥ 3 treatment-related adverse events were reported in 24 patients (55.8%) overall. Conclusion Surufatinib plus toripalimab showed encouraging antitumor activity and a tolerable safety profile in patients with treatment-naive advanced or metastatic PD-L1-positive NSCLC and previously treated SCLC. |
| format | Article |
| id | doaj-art-12397313df3b422c99fd04bc344604f6 |
| institution | Kabale University |
| issn | 1432-0851 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Springer |
| record_format | Article |
| series | Cancer Immunology, Immunotherapy |
| spelling | doaj-art-12397313df3b422c99fd04bc344604f62025-02-02T12:26:20ZengSpringerCancer Immunology, Immunotherapy1432-08512025-02-0174311310.1007/s00262-024-03932-xEfficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trialYing Cheng0Panpan Zhang1Ming Lu2Zhendong Chen3Lijie Song4Si Shi5Feng Ye6Xing Zhang7Baorui Liu8Dongmei Ji9Yanqiao Zhang10Weiguo Su11Michael Shi12Songhua Fan13Panfeng Tan14Chen Zhong15Department of Oncology, Jilin Cancer HospitalKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Centre, Peking University Cancer Hospital & InstituteState Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Gastrointestinal Oncology, Peking University Cancer Hospital & InstituteDepartment of Oncology, The Second Affiliated Hospital of Anhui Medical UniversityFirst Department of Oncology, The First Affiliated Hospital of Zhengzhou UniversityDepartment of Pancreatic Hepatobiliary Surgery, Fudan University Shanghai Cancer CenterDepartment of Medical Oncology, The First Affiliated Hospital of Xiamen UniversityBiotherapy Center, Sun Yat-Sen University Cancer CenterThe Comprehensive Cancer Center of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing UniversityDepartment of Medical Oncology, Fudan University Shanghai Cancer CenterSecond Department of Gastroenterology, Harbin Medical University Cancer HospitalHUTCHMED LimitedHUTCHMED LimitedHUTCHMED LimitedHUTCHMED LimitedHUTCHMED LimitedAbstract Background Combining the programmed death-1 inhibitor toripalimab and the angio-immuno kinase inhibitor surufatinib showed preliminary antitumor activity in patients with advanced solid tumors in a phase I study. Here, we report the efficacy and safety of this combination regimen in treatment-naive advanced or metastatic non-small-cell lung cancer (NSCLC) patients with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1% or greater (PD-L1-positive) and patients with previously treated small-cell lung cancer (SCLC). Methods This open-label, single-arm phase II study included patients with treatment-naive advanced or metastatic PD-L1-positive NSCLC or previously treated SCLC in China. Patients received surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every 3 weeks). Primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. Secondary endpoints included duration of response (DoR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety. Results Forty-three patients were treated (NSCLC cohort, n = 23; SCLC cohort, n = 20). ORRs (95% CIs) were 57.1% (34.0–78.2) in the NSCLC cohort and 15.8% (3.4–39.6) in the SCLC cohort. Median duration of response was not reached (NR) in both cohorts. Median PFS was 9.6 (5.5–NR) and 3.0 months (2.8–4.1), respectively, and median OS was 24.3 (10.8–NR) and 11.0 months (5.0–15.7), respectively. Grade ≥ 3 treatment-related adverse events were reported in 24 patients (55.8%) overall. Conclusion Surufatinib plus toripalimab showed encouraging antitumor activity and a tolerable safety profile in patients with treatment-naive advanced or metastatic PD-L1-positive NSCLC and previously treated SCLC.https://doi.org/10.1007/s00262-024-03932-xCombination therapyImmune checkpoint inhibitorImmunotherapyLung cancerSurufatinibToripalimab |
| spellingShingle | Ying Cheng Panpan Zhang Ming Lu Zhendong Chen Lijie Song Si Shi Feng Ye Xing Zhang Baorui Liu Dongmei Ji Yanqiao Zhang Weiguo Su Michael Shi Songhua Fan Panfeng Tan Chen Zhong Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial Cancer Immunology, Immunotherapy Combination therapy Immune checkpoint inhibitor Immunotherapy Lung cancer Surufatinib Toripalimab |
| title | Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial |
| title_full | Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial |
| title_fullStr | Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial |
| title_full_unstemmed | Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial |
| title_short | Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial |
| title_sort | efficacy and safety of surufatinib plus toripalimab in treatment naive pd l1 positive advanced or metastatic non small cell lung cancer and previously treated small cell lung cancer an open label single arm multicenter multi cohort phase ii trial |
| topic | Combination therapy Immune checkpoint inhibitor Immunotherapy Lung cancer Surufatinib Toripalimab |
| url | https://doi.org/10.1007/s00262-024-03932-x |
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