Camillo Porta, Francesco Massari, Tarek Taha, Enrique Grande, Maria T Bourlon, Ravindran Kanesvaran, Umberto Basso, Javier Molina-Cerrillo, Teresa Alonso-Gordoa, Zin W Myint, Giuseppe Fornarini, Thomas Buttner, Se Hoon Park, Yüksel Ürün, Ugo De Giorgi, Renate Pichler, Pasquale Rescigno, Tomas Buchler, Hana Studentova, Bohuslav Melichar, Jawaher Ansari, Veronica Mollica, Jakub Kucharz, Mimma Rizzo, Alessandro Rizzo, Ray Manneh Kopp, Sebastiano Buti, Fernando Sabino Marques Monteiro, Andrey Soares, Aristotelis Bamias, Matteo Santoni
{"title":"Pembrolizumab联合Lenvatinib治疗转移性肾细胞癌：来自国际ARON- 1研究的真实证据","authors":"Camillo Porta, Francesco Massari, Tarek Taha, Enrique Grande, Maria T Bourlon, Ravindran Kanesvaran, Umberto Basso, Javier Molina-Cerrillo, Teresa Alonso-Gordoa, Zin W Myint, Giuseppe Fornarini, Thomas Buttner, Se Hoon Park, Yüksel Ürün, Ugo De Giorgi, Renate Pichler, Pasquale Rescigno, Tomas Buchler, Hana Studentova, Bohuslav Melichar, Jawaher Ansari, Veronica Mollica, Jakub Kucharz, Mimma Rizzo, Alessandro Rizzo, Ray Manneh Kopp, Sebastiano Buti, Fernando Sabino Marques Monteiro, Andrey Soares, Aristotelis Bamias, Matteo Santoni","doi":"10.1007/s00262-025-04019-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Pembrolizumab plus lenvatinib is a treatment option for metastatic Renal Cell Carcinoma (mRCC). In the ARON-1 study we investigated we the real-world experiences gained from the use of this combination for mRCC.</p><p><strong>Methods: </strong>We retrospectively investigated real-world clinical outcomes of mRCC patients receiving pembrolizumab plus lenvatinib within the ARON-1 study. Overall survival (OS) was calculated from the start of pembrolizumab plus lenvatinib to death for any cause. Progression-Free Survival (PFS) was defined as the time from the start of pembrolizumab to progression or death from any cause. Duration of response (DoR) was defined as the time from the start of pembrolizumab to disease progression or death, whichever occurred first, in patients who achieved complete remission (CR) or partial response (PR). Overall Response Rate (ORR) was defined as the proportion of patients who achieve a CR or PR per RECIST criteria. Adverse events were retrospectively collected from electronic and paper charts and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.</p><p><strong>Results: </strong>Overall, we included 202 mRCC patients treated with pembrolizumab plus lenvatinib. The median follow-up time was 15.1 months. The median OS was not reached (NR), with a median PFS of 25.6 months and an Overall Response Rate (ORR) of 59%. The median Duration of Response (DoR) was 26.2 months. G3-G4 adverse events (AEs) were observed in 92 patients (46%), with hypertension being the most common AE (13%).</p><p><strong>Conclusions: </strong>Pembrolizumab plus lenvatinib is an effective and tolerable treatment for mRCC also in the real-world setting.</p>","PeriodicalId":9595,"journal":{"name":"Cancer Immunology, Immunotherapy","volume":"74 7","pages":"196"},"PeriodicalIF":4.6000,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12064502/pdf/","citationCount":"0","resultStr":"{\"title\":\"Pembrolizumab plus Lenvatinib in patients with metastatic Renal Cell Carcinoma: real-world evidences from the international ARON- 1 study.\",\"authors\":\"Camillo Porta, Francesco Massari, Tarek Taha, Enrique Grande, Maria T Bourlon, Ravindran Kanesvaran, Umberto Basso, Javier Molina-Cerrillo, Teresa Alonso-Gordoa, Zin W Myint, Giuseppe Fornarini, Thomas Buttner, Se Hoon Park, Yüksel Ürün, Ugo De Giorgi, Renate Pichler, Pasquale Rescigno, Tomas Buchler, Hana Studentova, Bohuslav Melichar, Jawaher Ansari, Veronica Mollica, Jakub Kucharz, Mimma Rizzo, Alessandro Rizzo, Ray Manneh Kopp, Sebastiano Buti, Fernando Sabino Marques Monteiro, Andrey Soares, Aristotelis Bamias, Matteo Santoni\",\"doi\":\"10.1007/s00262-025-04019-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Pembrolizumab plus lenvatinib is a treatment option for metastatic Renal Cell Carcinoma (mRCC). In the ARON-1 study we investigated we the real-world experiences gained from the use of this combination for mRCC.</p><p><strong>Methods: </strong>We retrospectively investigated real-world clinical outcomes of mRCC patients receiving pembrolizumab plus lenvatinib within the ARON-1 study. Overall survival (OS) was calculated from the start of pembrolizumab plus lenvatinib to death for any cause. Progression-Free Survival (PFS) was defined as the time from the start of pembrolizumab to progression or death from any cause. Duration of response (DoR) was defined as the time from the start of pembrolizumab to disease progression or death, whichever occurred first, in patients who achieved complete remission (CR) or partial response (PR). Overall Response Rate (ORR) was defined as the proportion of patients who achieve a CR or PR per RECIST criteria. Adverse events were retrospectively collected from electronic and paper charts and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.</p><p><strong>Results: </strong>Overall, we included 202 mRCC patients treated with pembrolizumab plus lenvatinib. The median follow-up time was 15.1 months. The median OS was not reached (NR), with a median PFS of 25.6 months and an Overall Response Rate (ORR) of 59%. The median Duration of Response (DoR) was 26.2 months. G3-G4 adverse events (AEs) were observed in 92 patients (46%), with hypertension being the most common AE (13%).</p><p><strong>Conclusions: </strong>Pembrolizumab plus lenvatinib is an effective and tolerable treatment for mRCC also in the real-world setting.</p>\",\"PeriodicalId\":9595,\"journal\":{\"name\":\"Cancer Immunology, Immunotherapy\",\"volume\":\"74 7\",\"pages\":\"196\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2025-05-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12064502/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Immunology, Immunotherapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00262-025-04019-x\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Immunology, Immunotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00262-025-04019-x","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Pembrolizumab plus Lenvatinib in patients with metastatic Renal Cell Carcinoma: real-world evidences from the international ARON- 1 study.
Background: Pembrolizumab plus lenvatinib is a treatment option for metastatic Renal Cell Carcinoma (mRCC). In the ARON-1 study we investigated we the real-world experiences gained from the use of this combination for mRCC.
Methods: We retrospectively investigated real-world clinical outcomes of mRCC patients receiving pembrolizumab plus lenvatinib within the ARON-1 study. Overall survival (OS) was calculated from the start of pembrolizumab plus lenvatinib to death for any cause. Progression-Free Survival (PFS) was defined as the time from the start of pembrolizumab to progression or death from any cause. Duration of response (DoR) was defined as the time from the start of pembrolizumab to disease progression or death, whichever occurred first, in patients who achieved complete remission (CR) or partial response (PR). Overall Response Rate (ORR) was defined as the proportion of patients who achieve a CR or PR per RECIST criteria. Adverse events were retrospectively collected from electronic and paper charts and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Results: Overall, we included 202 mRCC patients treated with pembrolizumab plus lenvatinib. The median follow-up time was 15.1 months. The median OS was not reached (NR), with a median PFS of 25.6 months and an Overall Response Rate (ORR) of 59%. The median Duration of Response (DoR) was 26.2 months. G3-G4 adverse events (AEs) were observed in 92 patients (46%), with hypertension being the most common AE (13%).
Conclusions: Pembrolizumab plus lenvatinib is an effective and tolerable treatment for mRCC also in the real-world setting.
期刊介绍：
Cancer Immunology, Immunotherapy has the basic aim of keeping readers informed of the latest research results in the fields of oncology and immunology. As knowledge expands, the scope of the journal has broadened to include more of the progress being made in the areas of biology concerned with biological response modifiers. This helps keep readers up to date on the latest advances in our understanding of tumor-host interactions.
The journal publishes short editorials including "position papers," general reviews, original articles, and short communications, providing a forum for the most current experimental and clinical advances in tumor immunology.
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