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Safety and efficacy of talacotuzumab plus decitabine or decitabine alone in patients with acute myeloid leukemia not eligible for chemotherapy: results from a multicenter, randomized, phase 2/3 study

Montesinos, Pau, Roboz, Gail J., Bulabois, Claude-Eric, Subklewe, Marion, Platzbecker, Uwe, Ofran, Yishai, Papayannidis, Cristina, Wierzbowska, Agnieszka, Shin, Ho Jin, Doronin, Vadim, Deneberg, Stefan, Yeh, Su-Peng, Ozcan, Mehmet Ali, Knapper, Steven, Cortes, Jorge, Pollyea, Daniel A., Ossenkoppele, Gert, Giralt, Sergio, Döhner, Hartmut, Heuser, Michael, Xiu, Liang, Singh, Indrajeet, Huang, Fei, Larsen, Julie S. and Wei, Andrew H. 2021. Safety and efficacy of talacotuzumab plus decitabine or decitabine alone in patients with acute myeloid leukemia not eligible for chemotherapy: results from a multicenter, randomized, phase 2/3 study. Leukemia 35 (1) , 62–74. 10.1038/s41375-020-0773-5

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Abstract

Talacotuzumab, a humanized anti-CD123 monoclonal antibody, was evaluated in combination with decitabine in elderly patients with acute myeloid leukemia (AML) not eligible for intensive chemotherapy. A multicenter, phase 2/3 study was initiated to determine the recommended phase 2 dose (RP2D) of talacotuzumab (Part A) followed by an open-label, randomized comparison of talacotuzumab in combination with decitabine versus decitabine alone to assess achievement of complete response (CR) and overall survival (OS) in Part B. Ten patients were enrolled in Part A and 316 in Part B; the results presented here are based on a database lock on January 25, 2018. Part A confirmed the RP2D of talacotuzumab to be 9 mg/kg. In Part B, CR was achieved in 12/80 (15%) patients receiving combination therapy and in 9/82 (11%) patients receiving decitabine alone (odds ratio: 1.4; 95% confidence interval [CI]: 0.6–3.6; p = 0.44). Median (95% CI) OS was 5.36 (4.27–7.95) months for combination therapy versus 7.26 (6.47–8.64) months for decitabine alone (hazard ratio: 1.04; 95% CI: 0.79–1.37; p = 0.78). Combination therapy showed no improvement in efficacy versus decitabine alone, resulting in the Independent Data Monitoring Committee’s recommendation of early termination of enrollment and discontinuation of talacotuzumab treatment.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Springer Nature
ISSN: 0887-6924
Date of First Compliant Deposit: 27 August 2021
Date of Acceptance: 13 February 2020
Last Modified: 17 Sep 2021 15:15
URI: https://orca.cardiff.ac.uk/id/eprint/143730

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