{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T11:35:53Z","timestamp":1793360153666,"version":"4.5.0"},"reference-count":29,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2024,9,1]]},"abstract":"Importance<\/jats:title>Cervical cancer is a common and lethal cancer worldwide. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the human transforming growth factor \u03b2 receptor II (or transforming growth factor \u03b2 trap) fused via a flexible linker to the C-terminus of each heavy chain of an immunoglobulin G1 antibody blocking programmed cell death 1 ligand 1.<\/jats:p><\/jats:sec>Objective<\/jats:title>To evaluate the safety and response rates of bintrafusp alfa in patients with recurrent or metastatic cervical cancer.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This phase 2 nonrandomized controlled trial evaluated bintrafusp alfa monotherapy in patients with recurrent or metastatic cervical cancer with disease progression during or after platinum-based chemotherapy. Data were collected from March 2020 to February 2022.<\/jats:p><\/jats:sec>Intervention<\/jats:title>Patients received bintrafusp alfa, 1200 mg, intravenously once every 2 weeks.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary end point was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by an independent review committee.<\/jats:p><\/jats:sec>Results<\/jats:title>At data cutoff, 146 of 203 screened patients received 1 or more doses of bintrafusp alfa; of these, the median (range) age was 53 (24-79) years. The study met its primary end point of a 95% CI above the objective response rate benchmark of 15%, with a confirmed objective response rate of 21.9% (95% CI, 15.5-29.5) per the independent review committee. Of these patients, 19 (59.4%) had a durable response of 6 months or more. At data cutoff, responses were ongoing in 13 of 32 responders (40.6%). The most common treatment-related adverse events were anemia (25 [17.1%]), rash (21 [14.4%]), hypothyroidism (15 [10.3%]), and pruritus (15 [10.3%]). Any-cause adverse events of special interest included anemia (82[56.2%]), bleeding events (81 [55.5%]), and immune-related adverse events (49 [33.6%]).<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>This phase 2 nonrandomized controlled trial of bintrafusp alfa met its primary end point, which may support the potential of a bispecific therapy targeting transforming growth factor \u03b2 and programmed cell death 1 ligand 1 in patients with recurrent or metastatic cervical cancer.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT04246489<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamaoncol.2024.2145","type":"journal-article","created":{"date-parts":[[2024,7,25]],"date-time":"2024-07-25T15:41:23Z","timestamp":1721922083000},"page":"1204","source":"Crossref","is-referenced-by-count":37,"title":["Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum 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