Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum Failure: A Nonrandomized Controlled Trial.
JAMA Oncol
; 10(9): 1204-1211, 2024 Sep 01.
Article
em En
| MEDLINE
| ID: mdl-39052242
ABSTRACT
Importance 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 ß receptor II (or transforming growth factor ß 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. Objective:
To evaluate the safety and response rates of bintrafusp alfa in patients with recurrent or metastatic cervical cancer. Design, Setting, andParticipants:
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. Intervention Patients received bintrafusp alfa, 1200 mg, intravenously once every 2 weeks. Main Outcomes andMeasures:
The primary end point was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by an independent review committee.Results:
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%]). Conclusions and Relevance 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 ß and programmed cell death 1 ligand 1 in patients with recurrent or metastatic cervical cancer. Trial Registration ClinicalTrials.gov Identifier NCT04246489.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias do Colo do Útero
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Recidiva Local de Neoplasia
Limite:
Adult
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Aged
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
JAMA Oncol
Ano de publicação:
2024
Tipo de documento:
Article