Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab in patients with recurrent and/or metastatic cervical cancer
| Autor: | Kathleen N. Moore, Alexandra Leary, Dominique Berton, Christina P. Opperman, Maria Del Pilar Estevez-Diz, Laurence Gladieff, Marek Ancukiewicz, Anne-Claire Hardy-Bessard, Frédéric Selle, Isabelle Ray-Coquard, Waldo Ortuzar Feliu, Carlos Rojas, Bradley J. Monk, David M. O'Malley, Ana Oaknin, Carla Rameri Alexandre Silva de Azevedo, Leslie M Randall, Jérôme Alexandre |
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| Přispěvatelé: | Institut Català de la Salut, [O'Malley DM] The Ohio State University, James Comprehensive Cancer Center, Columbus, OH, United States. [Oaknin A] Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Monk BJ] Arizona Oncology (US Oncology Network), Creighton University School of Medicine, Phoenix, AZ, United States. [Selle F] Groupe Hospitalier Diaconesses-Croix Saint Simon, Paris, France. [Rojas C] Centro de Investigacion Clinica, Bradford Hill, Santiago, Chile. [Gladieff L] Institut Claudius Regaud-Institut Universitaire du Cancer (IUCT)-Oncopole, Toulouse, France, Vall d'Hebron Barcelona Hospital Campus |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Diarrhea medicine.medical_specialty medicine.medical_treatment Programmed Cell Death 1 Receptor Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Uterine Cervical Neoplasms Phases of clinical research Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms Female::Uterine Neoplasms::Uterine Cervical Neoplasms [DISEASES] Other subheadings::Other subheadings::/drug therapy [Other subheadings] Antibodies Monoclonal Humanized Gastroenterology Drug Administration Schedule Coll uterí - Càncer - Tractament Internal medicine Clinical endpoint Humans Medicine Infusions Intravenous Adverse effect Immune Checkpoint Inhibitors Response Evaluation Criteria in Solid Tumors Aged Aged 80 and over Enterocolitis Cervical cancer business.industry Obstetrics and Gynecology Immunotherapy Middle Aged medicine.disease Progression-Free Survival Clinical trial Oncology Medicaments - Eficàcia Avaluació de resultats (Assistència sanitària) Female Neoplasm Recurrence Local medicine.symptom business neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales femeninos::neoplasias uterinas::neoplasias del cuello uterino [ENFERMEDADES] |
| Zdroj: | Scientia |
| ISSN: | 0090-8258 |
| DOI: | 10.1016/j.ygyno.2021.08.018 |
| Popis: | Cervical cancer; Checkpoint inhibitor; Immunotherapy Cáncer de cuello uterino; Inhibidor de puntos de control; Inmunoterapia Càncer cervical; Inhibidor de punts de control; Immunoteràpia Objective This phase II clinical trial evaluated the safety and antitumor activity of balstilimab, an anti-PD-1 antibody, in patients with previously-treated, recurrent/metastatic cervical cancer. Methods Eligible patients were 18 years or older with recurrent and/or metastatic cervical cancer and who had relapsed after a prior platinum-based treatment regimen for advanced disease. Balstilimab was administered intravenously at 3 mg/kg once every two weeks, for up to 24 months. The primary endpoint was objective response rate (ORR, RECIST v1.1) as assessed by an independent review committee. Results At data cutoff, 161 women (median age, 53 years [range 25–81]) were enrolled and treated with balstilimab. Of these, 140 had measurable disease at baseline and one prior line of platinum-based therapy in the metastatic, persistent, or recurrent setting; these patients were included in the efficacy analyses. The ORR was 15% (95% CI, 10.0%–21.8%) and included 5 patients with a complete response and 16 with a partial response. The median duration of response was 15.4 months. In patients with PD-L1-positive tumors the ORR was 20%, however patients with PD-L1-negative tumors also responded to balstilimab (ORR, 7.9%). Responses were not restricted to tumors of squamous cell histology, and an ORR of 12.5% was seen in the subset of patients with cervical adenocarcinoma. The disease control rate was 49.3% (95% CI, 41.1%–57.5%). Immune-mediated enterocolitis (3.1%) and diarrhea (1.9%) were the most common grade 3 or higher treatment-related adverse events. Conclusion Balstilimab demonstrated meaningful and durable clinical activity, with manageable safety, in patients with previously-treated, recurrent/metastatic cervical cancer. This study was funded by Agenus Inc. |
| Databáze: | OpenAIRE |
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