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ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2–Positive Gastric or Gastroesophageal Junction Adenocarcinoma
DC Field | Value | Language |
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dc.contributor.author | Klempner, Samuel J. | - |
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Shitara, Kohei | - |
dc.contributor.author | Metges, Jean-Phillippe | - |
dc.contributor.author | Lonardi, Sara | - |
dc.contributor.author | Ilson, David H. | - |
dc.contributor.author | Fazio, Nicola | - |
dc.contributor.author | Kim, Tae Yong | - |
dc.contributor.author | Bai, Li-Yuan | - |
dc.contributor.author | Moran, Diarmuid | - |
dc.contributor.author | Yang, Jianning | - |
dc.contributor.author | Arozullah, Ahsan | - |
dc.contributor.author | Park, Jung Wook | - |
dc.contributor.author | Raizer, Jeffrey J. | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Shah, Manish A. | - |
dc.date.accessioned | 2023-11-30T05:48:32Z | - |
dc.date.available | 2023-11-30T05:48:32Z | - |
dc.date.created | 2023-11-10 | - |
dc.date.issued | 2023-10 | - |
dc.identifier.citation | Clinical Cancer Research, Vol.29 No.19, pp.3882-3891 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://hdl.handle.net/10371/197573 | - |
dc.description.abstract | Purpose: Zolbetuximab, an IgG1 monoclonal antibody, binds to claudin 18.2 (CLDN18.2) and mediates tumor cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. We sought to examine zolbetuximab combinations in CLDN18.2-positive HER2-negative gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. Patients and Methods: This phase II study assessed efficacy and safety of zolbetuximab, alone or with modified FOLFOX6 (mFOLFOX6) or pembrolizumab, in CLDN18.2-positive advanced/metastatic G/GEJ adenocarcinoma. Patients received zolbetuximab as monotherapy in third/later-line (Cohort 1A, n ¼ 30), with mFOLFOX6 in first-line (Cohort 2, n ¼ 21), or with pembrolizumab in third/later-line (Cohort 3A, n ¼ 3) treatment. The primary endpoint for Cohort 1A was objective response rate (ORR). Key secondary endpoints were ORR (Cohorts 2 and 3A), overall survival (OS; Cohort 1A), and progression-free survival (PFS) and safety (all cohorts). Results: ORR was 0% in Cohorts 1A and 3A, and 71.4% [95% confidence interval (CI), 47.82–88.72] in Cohort 2. Median PFS was 1.54 months (95% CI, 1.31–2.56) in Cohort 1A, 2.96 months (95% CI, 1.48–4.44) in Cohort 3A, and 17.8 months (95% CI, 8.05–25.69) in Cohort 2. Median OS in Cohort 1A was 5.62 months (95% CI, 2.27–11.53). Gastrointestinal adverse events occurred across cohorts [nausea, 63%–90% (grade ≥ 3, 4.8%–6.7%) and vomiting, 33%–67% (grade ≥ 3, 6.7%–9.5%)]. Conclusions: Zolbetuximab plus mFOLFOX6 demonstrated promising efficacy in previously untreated patients with CLDN18.2-positive G/GEJ adenocarcinoma. These data support the first-line development of zolbetuximab in patients whose tumors are CLDN18.2-positive. Across cohorts, zolbetuximab treatment was tolerable with no new safety signals. | - |
dc.language | 영어 | - |
dc.publisher | American Association for Cancer Research | - |
dc.title | ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2–Positive Gastric or Gastroesophageal Junction Adenocarcinoma | - |
dc.type | Article | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-23-0204 | - |
dc.citation.journaltitle | Clinical Cancer Research | - |
dc.identifier.wosid | 001085034200010 | - |
dc.identifier.scopusid | 2-s2.0-85174080393 | - |
dc.citation.endpage | 3891 | - |
dc.citation.number | 19 | - |
dc.citation.startpage | 3882 | - |
dc.citation.volume | 29 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Lee, Keun-Wook | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | PLUS CHEMOTHERAPY | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordPlus | PEMBROLIZUMAB | - |
dc.subject.keywordPlus | NIVOLUMAB | - |
dc.subject.keywordPlus | STOMACH | - |
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