David M O'Malley1, Ana Oaknin2, Bradley J Monk3, Frédéric Selle4, Carlos Rojas5, Laurence Gladieff6, Dominique Berton7, Alexandra Leary8, Kathleen N Moore9, Maria D P Estevez-Diz10, Anne-Claire Hardy-Bessard11, Jérôme Alexandre12, Christina P Opperman13, Carla Rameri A S de Azevedo14, Leslie M Randall15, Waldo Ortuzar Feliu16, Marek Ancukiewicz17, Isabelle Ray-Coquard18. 1. The Ohio State University, James Comprehensive Cancer Center, Columbus, OH, United States. Electronic address: David.O'Malley@osumc.edu. 2. Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain. Electronic address: aoaknin@vhio.net. 3. Arizona Oncology (US Oncology Network), Creighton University School of Medicine, Phoenix, AZ, United States. Electronic address: Bradley.Monk@usoncology.com. 4. Groupe Hospitalier Diaconesses-Croix Saint Simon, Paris, France. Electronic address: fselle@hopital-dcss.org. 5. Centro de Investigacion Clinica, Bradford Hill, Santiago, Chile. Electronic address: cirojas@bradfordhill.cl. 6. Institut Claudius Regaud-Institut Universitaire du Cancer (IUCT)-Oncopole, Toulouse, France. Electronic address: gladieff.laurence@iuct-oncopole.fr. 7. ICO Centre René Gauducheau, Saint-Herblain, France. Electronic address: dominique.berton@ico.unicancer.fr. 8. Gustave Roussy Cancer Center, Villejuif, France. Electronic address: alexandra.leary@gustaveroussy.fr. 9. Stephenson Oklahoma Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: Kathleen-Moore@ouhsc.edu. 10. Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil. 11. Clinique Armoricaine de Radiologie, Saint-Brieuc, France. Electronic address: ac.hardy@cario-sante.fr. 12. Hôpital Cochin, Paris, France. Electronic address: jerome.alexandre@cch.aphp.fr. 13. Hospital Mãe de Deus, Porto Alegre, Brazil. 14. Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Recife, Brazil. 15. Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, United States. Electronic address: leslie.randall@vcuhealth.org. 16. Agenus Inc., Lexington, MA, United States. Electronic address: waldo.ortuzar@agenusbio.com. 17. Agenus Inc., Lexington, MA, United States. Electronic address: marek.ancukiewicz@agenusbio.com. 18. Centre Léon Bérard, Lyon, France. Electronic address: isabelle.ray-coquard@lyon.unicancer.fr.
Abstract
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.
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.
Authors: David M O'Malley; Maryna Neffa; Bradley J Monk; Tamar Melkadze; Marilyn Huang; Anna Kryzhanivska; Iurie Bulat; Tarek M Meniawy; Andrea Bagameri; Edward W Wang; Bernard Doger de Speville Uribe; Roberto Hegg; Waldo Ortuzar Feliu; Marek Ancukiewicz; Iwona Lugowska Journal: J Clin Oncol Date: 2021-12-21 Impact factor: 50.717
Authors: Michael J Birrer; Keiichi Fujiwara; Ana Oaknin; Leslie Randall; Laureen S Ojalvo; Christian Valencia; Isabelle Ray-Coquard Journal: Front Oncol Date: 2022-02-23 Impact factor: 6.244
Authors: Tynisha S Rafael; Jossie Rotman; Oscar R Brouwer; Henk G van der Poel; Constantijne H Mom; Gemma G Kenter; Tanja D de Gruijl; Ekaterina S Jordanova Journal: J Clin Med Date: 2022-02-19 Impact factor: 4.241
Authors: Carly A Burmeister; Saif F Khan; Georgia Schäfer; Nomonde Mbatani; Tracey Adams; Jennifer Moodley; Sharon Prince Journal: Tumour Virus Res Date: 2022-04-20
Authors: Corinne A Calo; David A Barrington; Morgan Brown; Lynette Gonzalez; Jae Baek; Allison Huffman; Jason Benedict; Floor Backes; Laura Chambers; David Cohn; Larry Copeland; Casey Cosgrove; Christa Nagel; David O'Malley; Kristin Bixel Journal: Gynecol Oncol Rep Date: 2022-07-08