{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T21:47:41Z","timestamp":1792619261916,"version":"4.5.0"},"reference-count":22,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"22","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>\n                      The phase III randomized open-label LEAP-015 study (ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04662710\">NCT04662710<\/jats:ext-link>\n                      ) evaluated first-line lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy for advanced metastatic gastroesophageal adenocarcinoma.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Eligible participants 18 years and older with untreated human epidermal growth factor receptor 2\u2013negative locally advanced unresectable or metastatic gastroesophageal adenocarcinoma were randomly assigned 1:1 to induction with oral lenvatinib 8 mg once daily plus pembrolizumab 400 mg intravenously once every 6 weeks (\u00d72) and investigators\u2019 choice of capecitabine and oxaliplatin once every 3 weeks (\u00d74) or fluorouracil, leucovorin, and oxaliplatin once every 2 weeks (\u00d76) and consolidation with lenvatinib plus pembrolizumab, or chemotherapy. Dual primary end points were progression-free survival (PFS) and overall survival (OS) in participants with PD-L1 combined positive score (CPS) \u22651 and all participants. Secondary end points included objective response rate (ORR) and duration of response.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Of 880 participants randomly assigned, 443 received lenvatinib plus pembrolizumab and 437 received chemotherapy. The median follow-ups were 32.2 months (range, 19.0-41.7) in participants with PD-L1 CPS \u22651 and 31.8 months (19.0-41.7) in all participants. At interim analysis, PFS was statistically significant with lenvatinib plus pembrolizumab versus chemotherapy in participants with PD-L1 CPS \u22651 (median, 7.3\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      6.9 months; hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.9];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .0012) and all participants (median, 7.2\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      7.0 months; HR, 0.78 [95% CI, 0.66 to 0.92];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .0019). The ORR was 59.5% versus 45.4% in participants with PD-L1 CPS \u22651 and 58.0% versus 43.9% in all participants,\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .0001 for both. At final analysis, OS was not statistically significant in participants with PD-L1 CPS \u22651 (median, 12.6\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      12.9 months; HR, 0.84 [95% CI, 0.71 to 1.00];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .0244;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      value boundary = .0204). Grade \u22653 drug-related adverse event rates were 65% versus 49%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy provided a statistically significant improvement in PFS in advanced unresectable or metastatic gastroesophageal carcinoma at interim analysis although the clinical significance of this difference seems to be limited. No significant improvement occurred in OS in participants with PD-L1 CPS \u22651.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-00748","type":"journal-article","created":{"date-parts":[[2025,5,31]],"date-time":"2025-05-31T08:00:26Z","timestamp":1748678426000},"page":"2502-2514","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":28,"title":["Lenvatinib Plus Pembrolizumab and Chemotherapy Versus Chemotherapy in Advanced Metastatic Gastroesophageal Adenocarcinoma: The Phase III, Randomized LEAP-015 Study"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct04662710","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5196-3630","authenticated-orcid":true,"given":"Kohei","family":"Shitara","sequence":"first","affiliation":[{"name":"National Cancer Center Hospital East, Kashiwa, 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