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A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML.
Zeidan, Amer M; Boss, Isaac; Beach, C L; Copeland, Wilbert B; Thompson, Ethan; Fox, Brian A; Hasle, Vanessa E; Hellmann, Andrzej; Taussig, David C; Tormo, Mar; Voso, Maria Teresa; Cavenagh, James; O'Connor, Tim; Previtali, Alessandro; Rose, Shelonitda; Silverman, Lewis R.
Afiliação
  • Zeidan AM; Yale University and Yale Cancer Center, New Haven, CT.
  • Boss I; Bristol Myers Squibb, Princeton, NJ.
  • Beach CL; Bristol Myers Squibb, Princeton, NJ.
  • Copeland WB; Bristol Myers Squibb, Princeton, NJ.
  • Thompson E; Bristol Myers Squibb, Princeton, NJ.
  • Fox BA; Bristol Myers Squibb, Princeton, NJ.
  • Hasle VE; Bristol Myers Squibb, Princeton, NJ.
  • Hellmann A; University Clinical Center of Medical University of Gdansk, Gdansk, Poland.
  • Taussig DC; The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom.
  • Tormo M; Hospital Clinico Universitario de Valencia and INCLIVA Biomedical Research Institute, Valencia, Spain.
  • Voso MT; AF Oncoematologia-Universita' di Roma Tor Vergata, Rome, Italy.
  • Cavenagh J; Barts Health NHS Trust, St. Bartholomew's Hospital, West Smithfield, London, United Kingdom; and.
  • O'Connor T; Bristol Myers Squibb, Princeton, NJ.
  • Previtali A; Bristol Myers Squibb, Princeton, NJ.
  • Rose S; Bristol Myers Squibb, Princeton, NJ.
  • Silverman LR; Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY.
Blood Adv ; 6(7): 2219-2229, 2022 04 12.
Article em En | MEDLINE | ID: mdl-34933333
Evidence suggests that combining immunotherapy with hypomethylating agents may enhance antitumor activity. This phase 2 study investigated the activity and safety of durvalumab, a programmed death-ligand 1 (PD-L1) inhibitor, combined with azacitidine for patients aged ≥65 years with acute myeloid leukemia (AML), including analyses to identify biomarkers of treatment response. Patients were randomized to first-line therapy with azacitidine 75 mg/m2 on days 1 through 7 with (Arm A, n = 64) or without (Arm B, n = 65) durvalumab 1500 mg on day 1 every 4 weeks. Overall response rate (complete response [CR] + CR with incomplete blood recovery) was similar in both arms (Arm A, 31.3%; Arm B, 35.4%), as were overall survival (Arm A, 13.0 months; Arm B, 14.4 months) and duration of response (Arm A, 24.6 weeks; Arm B, 51.7 weeks; P = .0765). No new safety signals emerged with combination treatment. The most frequently reported treatment-emergent adverse events were constipation (Arm A, 57.8%; Arm B, 53.2%) and thrombocytopenia (Arm A, 42.2%; Arm B, 45.2%). DNA methylation, mutational status, and PD-L1 expression were not associated with response to treatment. In this study, first-line combination therapy with durvalumab and azacitidine in older patients with AML was feasible but did not improve clinical efficacy compared with azacitidine alone. ClinicalTrials.gov: NCT02775903.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Azacitidina / Leucemia Mieloide Aguda Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Azacitidina / Leucemia Mieloide Aguda Idioma: En Ano de publicação: 2022 Tipo de documento: Article